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NR I Magazine

Oral Anticoagulants

And Other Medical Conditions

8

Reasons to Start Walking Take a Stroll

Dabigatran Demystified

“What Every Warfarin Patient Should Know”

Evolution or Revolution? INR Patient Self-Testing

Managing Your Fears

Good News for Every Patient and Their Loved Ones

Lovenox: The Other Blood Thinner Point-of-Care Home Monitoring : “Why Aren’t More Patients Using This?” Jack Ansell, M.D.

Exciting Breakthrough in Accurate Non-invasive Testing


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Contents 5

Dabigatran Demystified

11

Taking Care of your Heart

15

Oral Anticoagulants...and other medical Conditions

Marie B. Walker Henry I. Bussey, Pharm.D., FCCP, FAHA

Bonnie Arkus, RN

Diana M. Schneider, Ph.D.

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Test your INR at Home

26

Managing your Fears

30

Point-of-Care....and Anticoagulant Therapy

Rhonda Lollar, R.N.,L.H.R.M.

Wayne Carley

Jack Ansell, M.D. Professor of Medicine Boston University School of Medicine Director, Anticoagulation Service Boston Medical Center

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INR Patient Self-Testing: Evolution or Revolution

By David L .Phillips Vice President, Market Development, Alere, Inc.

INR Magazine is published by The Carley Group LLC www.inrmagazine.com

36

Take a Stroll

43

Lovenox: The Other Blood Thinner

19

Free copies of INR Magazine for your clinic

Wayne Carley

Reproduction of contents is prohibited without written permission.


Readers need to know... The contents of INR Magazine are for informational purposes only. Magazine content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or concern. NEVER disregard professional medical advice or delay seeking it because of something you have read in INR Magazine. INR Magazine does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information mentioned in this publication. Reliance or actions taken on any information provided by INR Magazine is the sole decision of the reader.


Would you take better care of your heart, if it were on the outside? Over 99% of Americans need to improve their heart health*.

That’s why it’s time we all start taking better care of our hearts. By reducing the risk of heart disease and stroke, we can all live healthier lives. The American Heart Association has all of resources we need to learn about ideal heart health, and simple steps that we can take toward living a longer life.

Today’s the day to start. For encouragement and support, visit todaysthedayistart.org.

*American Heart Assiciation survey 2010


Dabigatran Demystified â&#x20AC;&#x153;What Warfarin Patients Should Know About This New Anticoagulantâ&#x20AC;?

Marie B. Walker Henry I. Bussey, Pharm.D., FCCP, FAHA www.clotcare.org

The FDA recently approved a new anticoagulant drug called dabigatran (brand name Pradaxa), and much has been written about this new drug in both the news media and medical literature. This is the first orally administered alternative to warfarin (brand name Coumadin) to be approved by the FDA in more than 50 years since warfarin became available. The attention that dabigatran has drawn is in large part to the fact that frequent blood test and dosage titration are not required for this medication as is the case with warfarin. Most of the published information, however, has been directed at health care professionals or those with an interest in health cadre costs and pharmaceutical marketing. Little has been done to communicate to patients on warfarin (brand name Coumadin) what they should know about this new medication. This article will attempt to cover the key points you, as a warfarin patient, should know about dabigatran.

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What are some major differences between taking dabigatran and taking warfarin? If you are currently taking warfarin, then you probably know that the correct dose of warfarin has to be determined for each individual and may change from time-totime. Factors that may require a change in warfarin dose include such things as changes in diet, supplement use, physical activity, concomitant illness, alcohol use, smoking practices, and other issues. When taking warfarin, you should have your INR checked at least once every four weeks, and your clinician will adjust your dose as necessary to keep your INR in the target range, usually 2.0-3.0.

other conditions), tend to have the drug accumulate in the body if the dose is not reduced. With dabigatran, you take a capsule twice a day, and there is no blood test to measure the effect of the drug. Except for the special storage and handling issues addressed above, taking dabigatran is simple and not having a blood test every few weeks may sound appealing. On the other hand, fingerstick devices are readily available such that if you are taking warfarin, your INR can be checked with a quick stick of your finger rather than a traditional blood draw. Additionally, there is no way to monitor the effect of dabigatran, and there is no easy way to

â&#x20AC;&#x153;...no easy way to reverse the effect...â&#x20AC;? Dabigatran is a new medication that works by blocking the role of thrombin which plays a key role in the bodyâ&#x20AC;&#x2122;s ability to form a clot. This medication comes as two standard doses in the U.S., one that is to be used for most patients [150 mg twice daily] and a smaller dose [75 mg twice daily] for patients with reduced kidney function. In Canada, and perhaps other countries, a 110 mg capsule is available, but this size was not approved by the U.S. FDA. A lower dose [75 mg twice daily] is used in patients with reduced kidney function because the drug is eliminated from the body by the kidneys. Consequently, patients with reduced kidney function (as may occur in older people, those with diabetes and/or hypertension, or

reverse the effect of dabigatran if bleeding should occur. If you take too much warfarin and bleeding occurs, the effects of warfarin can be reversed by administering vitamin K or, if more urgent reversal is needed, by administering clotting factors. Can any warfarin patient switch to dabigatran? No. When the FDA approves a drug, it approves it only for specific conditions. Currently dabigatran is approved for patients with atrial fibrillation only. FDA approval was based largely on a study that involved more than 18,000 patients who received either warfarin or one of two doses of dabigatran (110 mg twice daily or 150 mg twice


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daily). In the future, dabigatran may be approved for other indications in which blood clots may be a problem; but in order for such approval to be granted by the FDA, the manufacturer will have to conduct clinical trials in patients who have the specific indication in question for anticoagulation.

Is dabigatran better than warfarin? In order to get approval from the FDA, dabigatran had to go through “non-inferiority” trials. The purpose of a non-inferiority trial is to show that the investigational drug (in this case, dabigatran) is at least as safe and effective as the comparator drug (in this case, warfarin). The trials do not have to show that the new drug is better than the old drug. In the trial mentioned above, dabigatran 110 mg twice daily was “non-inferior” to warfarin in preventing strokes and had less bleeding than warfarin. The dose of 150 mg twice daily was actually found to be superior to warfarin in preventing strokes but with a similar rate of bleeding complications. It also is important to understand that the studies look at group data. In other words, they have to show that the group on dabigatran does at least as well as the group taking warfarin. When you look at individual data, however, the results sometimes look different. For example, 50% of warfarin-treated patients in the study mentioned above had their INRs in range 67% of the time or more. In such patients, the data suggest that warfarin is more effective and safer than dabigatran. On the other hand, when you compare data from the 25% of warfarin-treated patients with the poorest INR control (INRs in range less than 53% of the time), then dabigatran appears to be safer and more effective.

Should I switch to dabigatran? So, what’s the bottom line; should you make the switch? Patients with severe reduction in kidney function and those with significant liver disease should not take dabigatran because of a potential increased risk of bleeding. Otherwise, the answer as to whether you should switch is…it depends. Well-managed warfarin appears to be safer and more effective than dabigatran. So, if you are taking warfarin and have a good clinician management system in place such that your INR is usually in range and stable, then warfarin is probably safer and more effective for you than dabigatran would be. If, however, your INR is often out of control and measures to improve INR stability have not worked, then dabigatran may be a better option for you.

__________________________________ INR References 1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. RE-LY Steering Committee and Investigators. Dabigatran vs warfarin in patients with atrial fibrillation. New England Journal of Medicine 2009; 361:113-51 2. Gage BF (2009) Can we rely on RE-LY? New England Journal of Medicine 2009; 361:1200-1202. 3. Wallentin L. www.theheart.org/article/1046957.do (accessed last on December 28, 2010)


INR: International Normalized Ratio

A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation tests.

INR Magazine is designed for the INR patient, their physician, clinician and their families to better understand effective warfarin use and management. Improved communication with one another, familiarity with new self-testing INR devices, supplies, technology, vitamin K dietary considerations, management tools, and exercise are key components to accomplishing this understanding. Many of the nations leading authorities on warfarin management, technology and related medical conditions will be featured in these quarterly issues, keeping both physicians and their patients aware of the latest studies, innovations and educational opportunities available. Over 4 million Americans are currently on warfarin therapy. Nearly 400,000 are mechanical heart valve recipients, and that number continues to increase in the United States with new and safer innovations in management and technology. The emergence of patient self-testing and portable point-of-care (POC) INR devices has revolutionized the industry and welcomed the personal involvement of patients in their warfarin management. Historically, warfarin testing has been done with a venous draw at the lab, physicians office, or clinic as needed with test results often taking days. The risks of clotting, stroke and bleeding were an on-going concern for physicians and patients. INR Magazine is committed to the continuing education of the warfarin patient under the supervision of their personal physician, to maintain the highest level of health and safety during their warfarin therapy. Thank you for reading INR Magazine.

Wayne Carley Publisher

INR Magazine

Publisher

Wayne Carley Literary Contributors

American Heart Association Henry I. Bussey Pharm.D., FCCP, FAHA Marie B. Walker, BBA Diana M. Schneider, Ph.D. Philips Remote Cardiac Services David L. Phillips Bonnie Arkus, RN Rhonda Lollar, R.N., L.H.R.M.

Subscriptions INR Magazine is provided at no cost to all physicians, clinicians and their patients upon request. Simply contact INR Magazine at:

free@inrmagazine.com We request that you provide postage to your practice when possible. The Carley Group 6080 Lakeview Rd. Suite 2605 Warner Robins, Ga. 31088 478.319.7177 All rights reserved. The Carley Group LLC Copyright 2010


www.womensheart.org

As the front-runner of the women and heart disease awareness movement, the Women’s Heart Foundation has been in your corner for 25 years. WHF strives to give you the most reliable and trusted information on topics such as a new groundbreaking non-invasive tool for accurate testing in women, best care models and the latest on “whole-health” and prevention. Take the Women’s Heart Risk Quiz online and become aware of your personal risk. Go to our Links page to easily connect to other great sites and resources. Sign up for e-News and join our Facebook page to keep abreast of WHF events and activities. This way, we can speak with one voice as we bring wellness and prevention to schools. Please consider making a donation. You can donate today online at www.WomensHeart.org and remember WHF in your Will. Take care of your heart.


H

Take Care of Your Heart

A new, highly accurate, risk-free inexpensive test for heart disease...

By Bonnie Arkus, RN

H

eart disease is our number one killer. It accounts for more deaths each year than all forms of cancer combined. Heart disease is a huge societal burden on patients and their families as well as on the economy. According to a recent policy statement from the American Heart Association, the current cost of heart disease is $273 billion - 17% of all health care expenditures – and that number is expected to triple by 20131. There has never been a better time for a new non-invasive, accurate and risk free test to better manage heart disease. Introducing the Multifunction Cardiogram™ or “MCG”. MCG is a revolutionary new test for diagnosing heart disease quickly, accurately and inexpensively. It can guide the physician on when more expensive riskier testing is needed. Through incorporating MCG into cardiology practices nationwide, inappropriate and unnecessary testing may be avoided, thereby saving billions of health care dollars and many lives.

The MCG machine collects the heart’s electric signals with the patient at rest using a 2-lead electro-cardiac signal recorder and a computer. The combined unit resembles an oversized laptop.

Through mathematical and computer systems analysis, the MCG measures the strain on the wall of the heart muscle with the resistance between the blood flow and the myocardium. A technician places five electrodes onto the patient – one on each wrist, one on each ankle and one over the heart – to capture electrical signals from the resting heart. To obtain an accurate reading, the patient must lie completely quiet and still for four minutes. The highly sensitive MCG machine amplifies the heart signals and then transfers the digitized information over the Internet to a data center where it is compared to more than 40,000 other patient’s heart signals. In just minutes, the MCG data center generates

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an automated report that is sent to the doctor’s email “IN” box. The MCG report is completely objective and indicates if a patient is suffering from coronary ischemia - lack of blood flow to the heart muscle. It also provides secondary and tertiary results as well and gives valuable information like the health of the patient’s heart valves, previous heart damage, arrhythmias (if present during the testing), and inflammation within the heart itself. The patient is given a disease severity score that ranges from zero to twenty, and leaves the physician’s office with reliable guidance on how to proceed. An MCG severity score of ≥ 4.0 plus a qualitative MCG diagnosis of local or global ischemia are indicative of the presence of relevant coronary stenosis (≥70%) in one or more coronary arteries. An MCG severity score between 0.0 and <4.0 is considered normal or indicative of the absence of relevant coronary stenosis (<70%). Clinical guidelines are from the American Academy of Urgent Care Medicine (AAUCM). MCG is amazingly accurate. In a recent study comparing MCG and SPECT Myocardial Perfusion Imaging for detection of relevant coronary artery stenosis (>70%)2, MCG correctly classified 103 of 116 patients (89%) as either having or not having coronary stenosis. SPECT nuclear

myocardial perfusion imaging was abnormal in 99 of the 116 patients undergoing cardiac catheterization (85%), but only correctly classified 54 of the 116 patients (47%) entered in the study as either having or not having relevant coronary stenosis.

MCG can be lifesaving. Here is a real-life patient scenario highlighting some of the advantages of MCG in clinical practice. Walter A. of Trenton, New Jersey was 84-years-old when he began experiencing periodic episodes of shortness of breath. It would come and go when he was cutting the lawn, preparing his pool for the summer season or simply going up the stairs. Then one day, his shortness of breath wouldn’t go away, and in fact, it became worse. That is when he made an urgent appointment to visit his primary care doctor. He was in congestive heart failure (CHF) and the ECG test indicated he had Atrial Fibrillation (“A-fib”), a rhythm disturbance that results in excessive beats and fluttering of the upper chambers of the heart. This can result in the backing up of fluid in the body and the lungs. He was placed on Lasix® - a diuretic, and advised to see a cardiologist right away. The next day, he was evaluated by a cardiologist and placed on Coumadin® - a blood thinner. The cardiologist wanted to do a stress test, but this test was contraindicated due to the severity of his CHF symptoms. The specialist said he still needed to rule out coronary artery disease as a possible contributor to the A-fib, so after Walter’s condition had stabilized for several weeks, he was admitted into the hospital to have a cardiac catheterization test – the “gold standard” for diagnosing coronary artery disease. Cardiac catheterization involves insertion of a large catheter into the femoral artery – a major


Cardiac catheterization involves insertion of a large catheter into the femoral artery – a major blood vessel. This can be very risky for a person taking Coumadin® due to the complication of hemorrhage. Consequently, Walter had to be first weaned from Coumadin® and placed on Heparin - a shorter-acting blood thinner, while awaiting the cardiac catheterization procedure. When Walter was wheeled to the 3rd floor surgical suite on Monday morning, there was a delay as too many patients were scheduled for the same procedure. Consequently, Walter was “bumped” and rescheduled for the next day. Stressed out, irritable and hungry, he was finally allowed some food at 4 o’clock in the afternoon. Tuesday morning, Walter was once again wheeled on a gurney to the surgical suite to have the cardiac catheterization procedure when an astute nurse noticed that Walter had a history of allergic reaction to IVP dye. “I’m sorry, Mr. A. We must have missed this. I see from the red label on the front of your chart that you are allergic to IVP dye.

he knew how best to treat me right away. That was 18 months ago. I underwent cardio-version, and I am back to my old self, though I must remain on Coumadin® probably for the rest of my life”. TAKE CARE OF YOUR HEART Finally, we have a risk-free non-invasive tool for diagnosing coronary artery disease with 89% accuracy – a tool that is equally effective in both women and men. MCG opens the door to wellness and prevention and can rapidly break down racial and ethnic barriers to care. It allows each of us to be proactive about our own heart health, working in true partnership with our practitioner. With MCG, heart disease can no longer hide. Soon, it will no longer be our number one killer. ______________________________________ INR 1 Heidenreich PA, Trogdon JG, Dhavjou OA, et al. Forecasting the future of cardiovascular disease in the United States. Circulation 2011; DO1:10.1161/CIR.ob013c31820a5515. Available at http://circ. ahajournals.org 2 Strobeck, Mangieri, Rainford, Imhoff, “A Paired-Comparison of

We cannot do your procedure today as you must undergo a special prep with steroid medication for several days to prevent an allergic reaction from occurring with the dyes we use for cardiac catheterization,” the nurse said. Walter had reached his limit, and his only response was, “I’m signing myself out of the hospital and having an MCG test.” Walter had the MCG test completed by a consulting cardiologist that Thursday afternoon. There was no prep, no exposure to dyes or X-ray, and no invasion to the body. In 15 minutes, Walter was given his MCG score - less than 4 - indicating he didn’t have significant coronary artery disease. The cardiac catheterization was no longer needed so he could remain on his Coumadin® schedule, possibly averting a stroke. “Thanks to MCG, my doctor learned I had primary atrial fibrillation, so

Multifunction Cardiiogram ™ (MCG) and Sestamibi SPECT Myocardial Perfusion Imaging to Quantitative Coronary Angiography for the Detection of Relevant Coronary Artery Stenosis (.70%) – A SingleCenter Study of 116 Consecutive Patients referred for Coronary Angiography”, poster presentation ACC Convention April 2011.

Bonnie Arkus is the founder and president of the Women’s Heart Foundation. www.WomensHeart.org. The views expressed are those of the author and do not necessarily reflect those of the Women’s Heart Foundation or of Premier Heart, the manufacturer of the Multifunction Cardiogram. There are currently 200 MCG machines in use in the United States. For more information about MCG, go to www.PremierHeart.com


Essential reading for anyone taking Coumadin® or warfarin, with the information your patients need to successfully manage their medications and minimize adverse events.

NEW!

The Coumadin® (Warfarin) Help Book Anticoagulation Therapy to Prevent and Manage Strokes, Heart Attacks, and Other Vascular Conditions Diana M. Schneider, Ph.D. “…this highly readable, reassuring little book provides me and all its users the confidence to simply stop worrying, take a deep breath, and get on with your life…” — Maggie Lichtenberg, author of The Open Heart Companion

“…a quick read; packed with vital information, [it] should be a part of prescribed care for all Coumadin® (warfarin) patients.” — Cleo Hutton, author of After a Stroke: 300 Tips for Making Life Easier

“… a comprehensive and thoroughly ‘user friendly’ guide...” — Midwest Book Review

“…read from cover to cover or use as a valuable resource when questions surface… If you or your loved one is told to take Coumadin® or warfarin, (this book) is essential for your understanding.” — Reader Views “…If you take Coumadin® (or the generic form) you need this book!!!” — Amazon.com Reviewer

The Coumadin® (Warfarin) Help Book is essential reading for anyone taking the anticoagulant drug Coumadin® or its generic form warfarin-especially if they find the dietary and medication guidelines confusing or complicated. Emphasizing that consistency is the key to success, the Help Book explains why these drugs require both dietary modifications and careful monitoring of both prescription and over-the-counter medications.

TO ORDER

In this book your patients will learn: • how Coumadin® and warfarin act to prevent the formation of blood clots that can cause strokes, heart attacks, or pulmonary embolisms; • why the level of these drugs must be maintained within a very narrow range; • the potential side effects of anticoagulant therapy, including the risk of bleeding when appropriate levels are not maintained as well as "nuisance" effects such as mild hair loss; • what they should know about the vitamin K content of foods, and how to regulate their diet to maintain clotting at the optimal effective level; • how both prescription and nonprescription drugs, as well as alcohol, can affect anticoagulant effectiveness, and how patients can work with their health care providers to maintain an optimal anticoagulant level while taking needed medications; • how coagulation therapy may be managed when they need surgery or are diagnosed with new medical conditions.

CONTENTS: Introduction. From the Author: How to Use This Book: General Guidelines for Successfully Managing Coumadin® and Warfarin. The Basics: Why Anticoagulation Is Necessary. What Is an Anticoagulant, and Why Is Controlling Blood Clotting So Important?; The Consequences of Abnormal Clot Formation: Stroke, Heart Attacks, and More; Common Conditions That Cause Blood Clots to Form. Successful Anticoagulation Management. How Should I Take Coumadin® or Warfarin?; Monitoring: Maintaining Your Clotting Rate in the Desired Range; Side Effects of Oral Anticoagulant Therapy; Dietary Considerations with Oral Anticoagulant Therapy; How Do Drugs and Supplements Affect Coumadin® or Warfarin Levels?; Anticoagulants and Other Medical Conditions. General Health Concerns. Managing Your General Health; Out and About: Managing Coumadin® or Warfarin Away From Home. Resources. Diana M. Schneider, Ph.D. is a biochemist and health publisher. She wrote this book following her own experience with taking Coumadin®, when she found that there was no single source of information about the drug and the need to balance diet and exercise, exercise care when taking other medications, or deal with side effects. She decided to base this book in her own experience to make it possible for anyone needing anticoagulation medication to live a normal, healthy life with minimal restrictions.

All DiaMedica publications are available at online bookstores, including Amazon.com and Barnesandnoble.com, as well as in your local bookstores. You can also visit our website at www.diamedicapub.com. If you would like to consider purchasing multiple copies of this book for use in your clinic setting or for courses or counseling programs, please contact us for review copies, a brochure written for patients, and for bulk pricing information.

CONTACT US

ISBN: 978-0-9793564-2-1 • Softcover • 112 pages • $14.95

DiaMedica Publishing 150 East 61st Street, New York, NY 10065 Phone: 212-752-2098 Email: info@diamedicapub.com Web: www.diamedicapub.com


Oral Anticoagulants and Other Medical Conditions

Excerpted from The Coumadin® (Warfarin) Help Book, Diamedica Publishing, 2008©, New York Diana M. Schneider, PhD

Whatever the condition for which you are taking Coumadin® or warfarin, you are as likely as anyone else to develop a wide range of medical conditions and illnesses, many of which can alter the way anticoagulant medication affects your body. In addition, drugs used to treat any newly diagnosed condition can change the rate at which the drug is absorbed from the gut, metabolized by your liver, and excreted by your kidneys. If you are prescribed any new medication, you might need to have your blood levels checked more frequently until they are stabilized. For this reason, all of your physicians and other medical providers need to know that you are on anticoagulant therapy.

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Drugs Used to Treat New Medical Conditions Whenever you develop a new medical condition, you will probably be prescribed one or more new drugs. Any new medications that will be taken long-term, such as those for high blood pressure or a thyroid condition, will require one or two extra INR checks to determine whether changes in your anticoagulant dosage are needed. Once this adjustment is made, you should remain stable as long as you are taking the new medication consistently. Medications taken short-term can alter your INR levels. Antibiotics are the most likely

changes are caught early, and also to reduce or eliminate the need for frequent visits for INR testing or monitoring by home nurses. Surgery and Noninvasive Medical Procedures If you require surgery for any reason, you will probably need to stop your anticoagulation therapy and switch to heparin for a few days before the surgery. I recently had a surgical repair on my shoulder and stopped taking Coumadin for a period of days. I also started taking what is termed “bridging” Lovenox®—an injectable form of heparin that clears from the system quickly, so that I would not bleed excessively during surgery.

“All of your physicians and other medical providers need class of drugs to have a significant effect on your INR, because they are metabolized by liver enzymes, and because they deplete your gut of the bacteria that produce vitamin K2.

Contact your physician or nurse to see if you should make any adjustments in your dosage while taking the new medication, and have your INR tested as they recommend during and after treatment. Diseases such as cancer, managed with multiple chemotherapeutic drugs and radiation, can have a profound effect on clotting. Sometimes these effects are predictable, but often they are not, and the combination of drugs needed to fight the disease may result in unpredictable and frequent changes in INR. This is a very good time to consider a home monitor, both to ensure that any major

I stopped taking the Lovenox two days before the surgery, and then began taking my usual dose of Coumadin the day after, which slowly increased back to normal levels over about a week. This ensured that there was no excessive bleeding during or after the surgery. Individuals at high risk for clot formation may need to use Lovenox immediately after surgery to quickly restore their INR to the effective range, but this can have serious effects on wound healing, as good clot formation provides the “bed” on which a scar is built. It is critical that all physicians involved in your care communicate about the risk management issues that may be involved, and especially that the physician who manages the medical condition for which you take Coumadin or warfarin and the surgeon have communicated regarding your therapy and


upcoming surgery. A good friend had major surgery for what turned out to be cancer, and the cardiologist who managed her anticoagulant therapy began giving her injectable heparin within 24 hours or surgery, apparently with little regard for the dangerous effects of anticoagulants on wound healing and without discussing balancing the risks of poor wound healing against the risk of clot formation.

As a result, neither the incision nor the underlying tissues healed properly, her cancer chemotherapy had to be delayed, and she developed a large hernia at the site of the incision that required a second surgery. Needless to say, she made very sure that no

to know that you are on anticoagulant therapy.â&#x20AC;? injectable anticoagulant was used after this second surgery (and of course she changed cardiologists and made sure that all of her physicians were now communicating with each other!) The applicable term is risk management, balancing the risks of clotting and a potential stroke, pulmonary embolism, or heart attack against the requirements of surgery and wound healing. Risk-management concerns apply to the treatment of many medical situations. You can help to prevent a poor outcome by educating yourself about potential problems and talking directly with all of the physicians involved in their management. This can be difficult when you are not feeling well and are facing a major medical procedure, so be sure you have a close friend or relative with

you during major visits, so you donâ&#x20AC;&#x2122;t miss any key information. The same concerns apply to medical procedures that are not major surgery but that have the potential to cause bleeding, such as a colonoscopy. My own gastroenterologist is comfortable doing a colonoscopy without the patient having to temporarily stop taking Coumadin or warfarin, and he would be able to remove a small polyp without concern. However, if he found a larger-sized polyp that needed to be removed, he would repeat the procedure to remove the polyp only after the patient had ceased taking oral anticoagulant medication for several days and used injectable heparin. Your physician might have a different view of the same situation,

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and in all cases, her advice should be followed. Medical Emergencies If you experience a fall or other injury, depending on its severity, you should go to the emergency room or visit your physician. Any uncontrolled bleeding, including blood in the urine or with a bowel movement, is also cause for an immediate checkup. An injury such as a deep bruise, even if it doesn’t involve visible bleeding, is also reason to contact your physician or nurse. If you need emergency surgery for any reason, be sure to tell the medical personnel involved that you take Coumadin or warfarin. They may need to administer vitamin K (Mephyton®) or pro-thrombin complex to reverse the effects of the drug so that surgery can be done safely and without excessive bleeding. This is an excellent reason to wear a MedicAlert® bracelet or other piece of identification jewelry, and also to carry a card in your wallet indicating that you take anticoagulant medication. Should you ever be unconscious and in need of immediate care, emergency personnel are trained to take notice of this information, and they will be able to safely manage your care.

Dental Cleaning and Surgery Routine teeth cleaning and procedures such as fillings generally do not warrant going off your anticoagulation therapy. Check with your physician and dentist about this. If you have a heart-related condition, your dentist will probably want you to take an antibiotic prior to cleaning. Any dental procedure that

involves the possibility of significant bleeding may require that you temporarily stop taking your anticoagulant medication. This would be the case, for example, with treatment for gum disease, implants, and extractions. You might need to temporarily stop taking your medication before cleaning, as well, if you have severe gum disease, with “spongy” gum tissue. A wide range of medical conditions can alter the way anticoagulant medication affects your body. Many of the drugs that may be used to manage these conditions can change the rate at which your anticoagulant is absorbed from the gut, metabolized by your liver, and excreted by your kidneys. For this reason, you may need to have your INR checked more frequently until your body is stabilized on new medications. If you require surgery for any reason, you will probably need to stop your anticoagulation therapy and switch to short-acting injectable heparin for a few days before the surgery, so that your blood clotting will be in the normal range at the time of the surgery, to prevent excessive bleeding and allow for optimal healing. You may also need to make minor adjustments in your anticoagulation management for procedures such as colonoscopies and major dental work. Risk-management concerns apply to the treatment of many medical situations. You can help to prevent a poor outcome by educating yourself about potential problems and talking directly with all of the physicians involved in their management.

__________________________________ INR


INR Magazine

INR Magazine is provided at no cost to all of your patients through your clinic or practice.

Physicians and clinicians wishing to request copies of INR Magazine for their practice, clinic and patients may do so by contacting INR Magazine at:

free@inrmagazine.com

We ask that you provide postage costs to your clinic. We have no wish to contact your patients. Patients wishing to receive copies of the magazine are requested to inquire at your physicians office or warfarin clinic. INR Magazine is provided at no cost other than postage. Thank you for your interest in INR Magazine and your support of patient education. INR Magazine Wayne Carley 6080 Lakeview Road Suite 2605 Warner Robins, Ga. 31088 Comments or questions? wayne@inrmagazine.com

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Test your INR at

home...

...with INR self-testing.

By Rhonda Lollar, R.N.,L.H.R.M.

What if you could cut out a trip to your doctorâ&#x20AC;&#x2122;s office or lab each month AND reduce your risk for complications? With INR self-testing you could do just that.


The availability of new simple-to-use technologies and services that allow people to take more control over their own care and spend less time in doctor’s offices and clinics is changing health care as we know it. Some of these technologies and services are in-home

self-testing—is bringing improved quality of life and convenience to thousands of people taking the oral anticoagulation medication warfarin (Coumadin®) commonly known as a blood thinner. You and more than four million people in the United States take blood thinners every day, which means frequent blood testing to avoid the risk of serious complications (such as stroke or bleeding). Complications can occur if your INR levels go out-of-range. Unfortunately, these complications are some of the most frequent causes of emergency room visits. Until recently, individuals who take warfarin have had to travel to a lab, clinic, or doctor’s office at least once a month to have a blood test to measure their INR level. In the lab, this test usually requires a needle stick and vial of blood drawn, and the results aren’t available until a day or two later. What is INR self-testing?

monitoring devices and personal emergency response services that allow people to stay in touch with their medical providers and caregivers, while living independently. One of the fastest growing of these services—INR

Now there is a service (approved by Medicare in 2008) called INR self-testing that allows people taking blood thinners to test their blood levels from the convenience of their own home, or wherever they travel and get their INR results immediately. You can do this using a small, simple-to-use meter that is similar to a glucose meter used by millions of diabetics. These self-testing meters only require a drop of blood from a tiny fingerprick, thereby eliminating the needle and blood draw required in the lab.

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How it works The first thing to know is that self-testing is not for everyone, so if you or someone you know is interested, they should discuss it with their doctor or nurse, because it requires a prescription. The self-testing meter, supplies and training are provided by a Medicare-approved selftesting company that works closely with the doctor’s office and the patient. The home test requires a finger prick and a small drop of blood applied to a test strip. The meter displays the results within a minute or two. The patient then calls the self-testing company

of complications associated with being out of range. This is because more frequent testing allows the doctor to see trends developing sooner, and adjust the medication dose before a complication occurs, such as bleeding or stroke. As a result of these published studies, doctor groups like the American Heart Association and the American College of Cardiology endorse INR self-testing. At the end of 2010 there were an estimated 100,000 people in the United States self-testing their INR levels, and that number is growing 25-30% per year.

The entire test and reporting process takes only 10 minutes... and reports the results. The test results are immediately compared to the levels ordered by the doctor. If the test is out-of-range, the patient’s doctor or clinic is notified within minutes of the test. This allows the doctor to adjust the medication dose sooner, thereby reducing the risk of potentially dangerous complications. The entire test and reporting process takes only 10 minutes, and can be done from home or anywhere you travel, since the meters are small and battery operated. This makes it easy to test every week, and weekly testing is important. Why doctors recommend it Clinical studies have shown that patients who self-test every week can reduce the risk

Who pays for it? Because INR self-testing has proven so effective, Medicare and most commercial health plans now pay for all or part of the cost for patients with these conditions:

• • • •

Mechanical heart valve Atrial fibrillation DVT (deep vein thrombosis) Pulmonary embolism

Depending on the health plan, some patients may have a small monthly co-pay. The self testing company will first check your insurance coverage and inform you what—if any—your cost will be, so you can make an informed decision before starting.


How to get started The first thing to do is have a conversation about self-testing with your doctor or clinic manager. Self-testing is only available with a prescription, and for some people it may not be appropriate. You need to be able to perform a finger prick, and apply a drop of blood to a test strip. You also need to be motivated to follow your doctorâ&#x20AC;&#x2122;s orders, and willing to perform a 10-minute test every week. But if you are like the many thousands of people who are self-testing, it may very well change your life! __________________________________ INR

To learn more, please visit www.inrselftest.com, or call (877) 794-3126.


Real patients. Real experiences. INR self-testing

“I am an active retired person and travel quite frequently. I didn’t want Coumadin to change my lifestyle. But with selftesting, my life hasn’t changed at all. I travel with my wife, do work on my house, and have never been hospitalized because of my Coumadin.” “I know with weekly testing that I am kept in range more often. How can monthly testing do that?” “I’m 73 years old and I want to maintain my high quality of life for as long as I can. INR self-testing makes me feel more in control of my life and my health. And it puts my wife’s mind at ease that I am getting the best care possible.” - Donald G., Philips INR@Home patient “Because of INR self-testing, our life is the same as it was before my husband started Coumadin. I don’t need to worry about him—the Philips service gives me peace of mind.” - Kathleen G., Donald’s wife Talk to your doctor today to see if INR self-testing is right for you. Call (877) 794-3126 or go online to www.inrselftest.com to learn more.

Philips Remote Cardiac Services 7 Waterside Crossing, Windsor, CT 06095 Service available by prescription only.


PT/INR self-testing has many health benefits Not only is INR self-testing convenient and reliable, but did you know it also has health benefits? In scientific studies, patients who self-tested their INR were in therapeutic range for more time than patients who tested their INR in a lab or clinic.1 The self-testing patients in the study were also at lower risk of complications2 and death3. Talk to your doctor today to see if INR self-testing is right for you. Call (877) 794-3126 or go online to www.inrselftest.com to learn more. Service available by prescription only.

Philips Remote Cardiac Services 7 Waterside Crossing, Windsor, CT 06095

1 Beyth RJ, et al. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. Ann Intern Med. 2000;133:687-695. 2 Heneghan C, et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006; 367:404-11. 3 Bloomfield, et al. Meta-analysis: Effect of Patient Self-testing and Self-management of Long-Term Anticoagulation on Major Clinical Outcomes. Ann Intern Med. 2011;154:472-82.


Managing Your Fears There are 2 basic types of fear; rational and irrational. For patients who have been diagnosed with a variety of heart related medical conditions such as atrial fibrillation, deep vein thrombosis, heart disease, heart valve replacement, risk of stroke or some other diagnoses that requires long term warfarin therapy, the fear is rational. Irrational fears may take the form of a phobia; an intense and persistent fear of certain situations, activities, things, animals, people and for some patients, their health condition. The primary symptom of this disorder is the excessive and unreasonable desire to avoid whatâ&#x20AC;&#x2122;s causing the fear. When the fear is beyond our control, and if the fear is interfering with daily life, then a diagnosis under one of the anxiety disorders may apply. This fear may range from mild discomfort, to an intense anxiety that inhibits all social contact. The natural fight or flight response is tattooed on our DNA, and itâ&#x20AC;&#x2122;s the flight response that this article will focus on. The greatest fear for the average American is the fear of speaking in public. Is this rational or irrational? The physical effects on the body can be very real and dramatic causing a sudden rise in blood pressure, racing heart, sweating, dizziness, chest pain, weakness and overall panic. The emotional effects can be just plain terrifying. Are we actually in physical danger and at risk of death or injury? Of course not, but the effects on our mind and body are real.


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Stories of professional athletes, entertainers and speakers becoming physical ill just prior to a performance, even after decades of experience, are very real. The mind is a powerful force. Phobias such as the fear of speaking in public are not usually diagnosed if they are not particularly distressing to the individual and are not frequently encountered. If a phobia is disabling on some level to the individual, then it can be treated depending on how severe it is.

There is an overall basic distinction between fear and anxiety. Anxiety is a vague unpleasant emotional state with qualities of apprehension, dread, distress, and uneasiness. In addition it is objectless. Fear is similar to anxiety except that fear has a specific object….that object being our newly discovered physical state that brings with it a new mental state. Can a person be both anxious and fearful about the same thing? In this case, the answer is yes they can, and both will have to be dealt with.

Control.....or the loss of it is a new enemy A medical diagnoses that has been confirmed as real leads us to a reasonable conclusion that we are at risk. For each patient, there are dozens of variables of course that directly impact the level of risk from day to day. Early diagnosis of a condition may give us some peace of mind that we are in no imminent danger. A sudden heart attack on the other hand is a dramatic wake-up call that danger to our very life is real and impending. Unlike the unseen dangers we face daily crossing the street or driving to work, a known threat to our existence or quality of life internally cannot be avoided by changing our routine or travel plans. It is part of who we are now and life may never be the same.

Control……specifically the loss of it, is a new enemy for the newly diagnosed. Loss of control refers to a situation when there are unpredictable or uncontrollable events in one’s life which lead to anxiety and/or depression. As a result, feelings of helplessness develop. The unpredictability which may be associated with a task may cause anxiety (Seligman, 1975). The inability or perceived inability to make an adaptive response to a threatening event or the fact or perception that no such response is available will lead to feelings of anxiety. Since anxiety is very ambiguous, it is the key which prevents the elaboration of clear action patterns to handle the situation effectively (Lazarus, 1991).

At the point of this new realization of our mortality and actual physical condition, we have to make some choices mentally. How will we respond emotionally to this new knowledge and how will it affect our daily life from this point forward?

For the warfarin patient, the risks associated with their diagnosed medical condition has the additional risk associated with warfarin use. These too are rational concerns that may cause fear and/or anxiety. Past studies have revealed that patients who have been taking


warfarin may have suffered large amounts of bleeding in the brain and an increased risk of death if they suffer from a hemorrhagic stroke.

“Control what you can....” In past years, it was reported that warfarin’s side effects sent more elderly patients to the emergency room every day than any other medication. The reason for this is believed to be that the correct dosages for warfarin were not determined or managed correctly. Taking any drug in the wrong dose or not managing the use of prescribed medications always carries with it increased risks of sideeffects or life threatening conditions. These risks caused by mismanagement of medication are avoidable and the serious harm resulting from those poor patient choices can be prevented. Management and prevention are certainly controllable activities and well within our power when it comes to our health responsibilities. Controlling what you can is an important asset for the warfarin patient. The good news for patients on warfarin is that a higher level of control is available to them as never before. Medications prescribed by your physician to treat your particular disease should always be used precisely as directed. Focus on this: The mind can only think of one thing at a time. Any idea or subject you’re thinking about at that moment directly affects your state of mind and then your physical well being. If you are worried about a loved one, then worry dominates your mind. If you are

thinking happy thoughts about a recent celebration or event, then your mind translates those happy thoughts into happy feelings... thus a healthy bodily response. So if you’re constantly thinking about how scared you are, or how sick you are...it totally occupies your thoughts, creating unhealthy feelings, causing anxiety, depression, increased fear, insomina...and the list goes on. As you think...so you feel.

With Medicare’s recent decisions regarding reimbursement for many heart conditions requiring warfarin use, weekly testing has become the new standard for responsible management. The knowledge from week to week that your warfarin levels are correct and therapeutic offers tremendous solace that we are controlling our use of this medication, reducing our risks and therefore reducing the possibility of adverse events or life threatening conditions. Peace of mind is a powerful level of control and that control is available to the warfarin patient. This “peace of mind” becomes a new weapon against anxiety, fear and the debilitating physical response patients often experience. The reassurance and comfort of effective control and management are both mentally soothing and physically healing. __________________________________ INR • Gerald, C. (1996). Theory and Practice of Counseling and Psychotherapy, 5th ed. CA: Brooks/Cole Publishing Company. • Carissa Kelvens (1997) Fear and Anxiety, California State University • Franken, R. E. (1994). Human Motivation, 3rd ed. CA: Brooks/Cole Publishing Company. • Kalat, J. W. (1992). Biological Psychology, 4th ed. CA: Brooks/Cole Publishing Company.

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Point-of-Care Home Monitoring of Anticoagulation Therapy: “Why are patients not using it?” Jack Ansell, M.D. Professor of Medicine Boston University School of Medicine Director, Anticoagulation Service Boston Medical Center

Warfarin has been the principal oral anticoagulant in use in the United States for a variety of thrombotic diseases since the 1950s. Warfarin therapy, however, has many drawbacks, principally among them, the complexity and labor intensiveness of therapy and the high risk of adverse events, often due to poor dose management. Anticoagulation clinics, that focus predominantly on managing warfarin dosing, are now commonplace, and generally result in better outcomes than individual physicians managing a small group of patients (denoted as “usual care” to differentiate it from anticoagulation clinic care)1. In 1987, technology was introduced employing portable instru-

ments that made it possible to perform prothrombin times from a finger stick sample of blood, much as blood sugar is measured in diabetics2. These point-of-care (POC) instruments are now widely used in physician offices to the point that approximately 1/3rd of all INRs performed in the US are performed on aPOC instrument. Given their size, portability, and ease of use, these devices allow patients to measure their own prothrombin time (PT) at home (patient-self testing or PST), and with proper education, manage their own anticoagulation dosing (patientself management or PSM)3. There are currently a number of devices on the market


that are practical for home use. New instruments are also in development.

All POC PT instruments employ tissue thromboplastin to initiate clot formation, but then use different means to detect clot formation. Exhaustive correlation studies have been done to assess the accuracy and precision of POC instruments with plasma PTs using international standards. When tested under controlled conditions, POC devices have consistently confirmed the adequacy of this methodology for the monitoring of oral anticoagulation4. There was great hope that developing PST or PSM models of care would vastly improve

the outcomes of therapy5. With this in mind, a number of clinical trials demonstrated improved outcomes as measured by the time spent in therapeutic range, or in some instances, as a reduction of major hemorrhage or thrombosis when compared to a usual care model, or even to the outcomes achieved by anticoagulation clinics6-8. In the latter situation the differences are less striking. However, the hope-for-widespread application of such testing never developed in North America, nor in many other countries outside of Germany, where, in contrast to other regions, a number of factors coalesced to promote such therapy.

31


Currently, more than 100,000 individuals with mechanical heart valves or atrial fibrillation in Germany are monitoring and managing their own therapy at home. In the United States, that number is estimated to be only 10,000 individuals who are employing home monitoring (out of a potential base of 2.5 million on oral anticoagulation). A number of factors have served as barriers to implementation of home testing in the US. The lack of large, randomized, prospective trials showing the benefit of PST/PSM was an early barrier. Only in the last few years have such studies been conducted and metaanalyses of these studies have consistently shown a benefit for PST or PSM. The lack of physician education of the benefits of this technology has been another barrier. Questions about the safety and accuracy, as well as physician liability have been a third barrier. Some private insurers, however, will reimburse costs, but on an unpredictable basis. Home monitoring is now largely implemented through companies called independent diagnostic testing facilities (IDTFs). These businesses will usually provide the instruments, train the patients, and often keep track of the INRs for physicians who prescribe home monitoring. Reimbursement is provided on a per test basis after the initial reimbursement for training and implementation. For now, most anticoagulation therapy in the US is still managed by the individual physician. While anticoagulation clinics, managing large panels of patients, continue to grow

at a rapid rate, the growth of patient home monitoring has not progressed to any major extent. For those of us who understand the benefits of PST/PSM and who are committed to improving patient care, we will continue to educate and advocate for our patients with the long-term objective of providing the best possible model of anticoagulation care available. __________________________________ INR

References 1. Ansell J, Hirsh J, Poller L, Bussey H, Jacobson A, Hylek E. The pharmacology and management of the vitamin K antagonists. Chest 2004;126(Suppl):202S-231S. 2. Leaning KE, Ansell JE. Advances in the monitoring of oral anticoagulation: Point-of-care testing, patient self-monitoring, and patient self-management. J Thromb Thrombolys 1996; 3:377-383. 3. Ansell J, Hasenkam JM, Voller H, Jacobson A, Levy J. Guidelines for implementation of patient self-testing and patient self-management of oral anticoagulation. Internat J Cardiology 2004;99:37-45. 4. Sickles J, Elston-Lafata J, Ansell J. Point-of-care testing in coagulation and haemostasis: Implications for patient management. Dis Manage Health Outcomes 1999;6:291-301. 5. Ansell JE. Empowering patients to monitor and manage oral anticoagulation therapy. JAMA 1999;281:182-183. 6. Christensen TD. Self-management of oral anticoagulant therapy: A review. J Thromb Thrombolys 2004;18:127-143. 7. Siebenhofer A, Berghold A, Sawicki PT. Systematic review of studies of self-management of oral anticoagulation. Thromb Haemost 2004;91:225232. 8. Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367:404-411.


INR Patient Self-Testing

n o i t volu

E

? n o i t u l o

v e or R

By David L .Phillips

Vice President, Market Development, Alere, Inc.

LET’S START with a scene from the movie you

may remember from almost 20 years ago, “Other People’s Money.” Gregory Peck, as the beleaguered president of New England Wire and Cable, is making an impassioned plea to the stockholders to save the company, the plant, and the jobs. Danny DeVito, playing Lawrence Garfield (a.k.a. Larry The Liquidator), speaking for the stockholders, says that it’s not that New England Wire and Cable makes a bad product or provides poor service; in fact, just the opposite. However, the market demands fiber optics. As it turns out, the female lead comes up with an idea to retool the plant to make the wire mesh used in the manufacturing of automobile airbags, then sell the wire mesh to the auto makers. The plant is saved, the jobs are secure and everyone lives happily ever after. I have clearly stretched this analogy to make a point. The point being that adaptation or evolution has been key to the success of US industry and this can also be said about the improvements in health care delivery in the United States. Many improvements or changes in health care are evolutionary, such as patients taking on more responsibility for their own health care. So, is the availability of INR Patient Self-Testing (PST) evolutionary or revolutionary? In order to answer the question, let’s first look at forces driving

this trend. For example, why are demands for testing closer to the patient suddenly on the rise? There are two forces that are accelerating this trend. First, is the every increasing cost of health care delivery which can be reduced by keeping the patient out of the hospital and the second is technological innovations that have taken place in the industry which has enabled the devices to become smaller, faster and easier to use. There is not much to add the first point. We are all aware of the cost of health care. Our insurance premiums have continued to increase even as the benefits have continued to decrease. On the second point, technology has been an enabler of this movement. If we examine the evolution of blood glucose monitoring dating back to the 1960’s, glucose testing could only be done in a hospital clinical laboratory. This same test can now be done by any diabetic using an extremely small sample obtained from several locations on the body. A similar evolution in INR testing has taken place over the last 15 to 20 years. But to do this, we need to first look at the development of the whole blood monitoring systems because before there was PST there was INR testing at the point-of-care or POC. Back in the 1970’s, the prothrombin time test or PT test was only done in large clinical laboratories on

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large instruments. Then in the mid-1980’s, the first finger stick instruments were developed. In the last decade, new generations of reliable point of care testing systems have provided the means, thus driving the trend toward patient-self testing. By combining convenience and simplicity along with the reliability of these monitors, these testing systems can provide the physician and the patient with timely and more frequent INR results that enables the doctor to make better therapeutic decisions and to provide the patient with a more convenient method which can also aid the patient in managing their life while on warfarin. These newer generations of systems combine precision engineering with integrated reagents, therefore minimizing operator intervention and making laboratory quality information available to virtually any properly selected and suitable trained patient. Many of these systems are self-calibrating and have on-board comprehensive self-diagnostics as well as integrated quality controls to eliminate believable but erroneous results being acted upon that could harm the patient. These improvements made the testing simple and reliable enough that the FDA cleared the first monitors for PST in 1997. There are now second and third generation instruments in the market. The manufacturers of the devices and test strips know that PST will never replace the physician as fiber optics replaced wire cable. Rather, INR PST should be another option the doctor has in addition to the current methods of managing chronic warfarin patients. And for patients it provides a much more convenient method for testing

and can reduce the trips to the doctor’s office while improving anticoagulation management. Taken together, accurate, reliable and rapid results can directly improve the care of any patient especially those with a chronic condition that needs routine and reliable information. The adoption of PST by a patient taking warfarin and the attending physician is not to be taken lightly. It is important to consider three ‘non-technical’ ingredients - commitment, communication, and cooperation. These are and should be considered by both the patient and physician. The patient should be committed to following the doctor’s orders, communicating with the physician through the service provider and finally cooperating with the physician. By combining these measures both the patient and the doctor should realize gains in patient satisfaction and patient management quickly. In October 2008 the Managed Care Journal (Volume 17, No. 10 Supplement 9) published a supplement titled, “Oral Anticoagulation Patient Self-Testing: Consensus Guidelines For Practical Implementation”. While it contained guidelines that were developed by a panel of physicians and other health care providers for physicians interested in prescribing PST to their patients, it highlighted several points that patients should consider, too. Patient selection – While physicians generally ask is the patient ready, willing and able to self-test, patients should ask themselves if they want to become part of their “care team”. Are they comfortable with sticking their own


finger to obtain a drop of blood for their INR test? Will they follow the doctor’s instructions? Communication between the physician and the patient – this is key and requires communication in both directions, the practice should maintain routine communication with the patient and the patient should be proactive in their management, keeping the doctor informed of any changes in diet or starting other medications either prescribed or over the counter. Training – this is extremely important and cannot be overstated. Is the patient willing to participate in training on the proper use of the PST monitor in the context of a comprehensive management plan? Will they attend face-to-face training and follow all procedures for testing, communicating results, complying with dose adjustments, and attending follow-up office visits? Do they have access to a telephone or other device to communicate with the doctor? Will they follow the directions and pointers for obtaining a good blood sample? Will they read and understand the Operator’s Manual and ask questions to make sure they are performing the test properly? Ongoing follow-up – Taking warfarin and doing PST is generally for chronic conditions so the ongoing follow up may last for years. Will they continue to monitor their diet, keep good records and maintain their monitor per manufacturer’s instructions? So, if we are all “stockholders” like Larry the Liquidator, we look to the health care industry to adapt and evolve. As many physicians state, “If we are honest about making patient

care our primary concern, we will welcome the arrival of new, reliable testing systems. Health care providers must recognize that there are times when the needs of the patient are best met by a system in the patient’s home and not at the doctor’s office.” Patient self-testing can provide the freedom from frequent and time consuming trips to the doctor’s office all the while giving the doctor and the patient much more information as to their coagulation status. PST enables the warfarin patient to be part of their care team by providing the ability to keep a watchful eye on any changes in diet, medications or acute illness that could affect the therapeutic effect of warfarin. Finally, is the trend to PST evolutionary or revolutionary? I believe it is clearly an evolutionary change where the decentralization of laboratory testing is an “extension” of laboratory and physician services, not a replacement. And like a surprise ending to a story, the outcome could be a Hollywood finish where the real winner in all of this is the person taking warfarin. PST is not for everyone, so ask your doctor if INR patient self-testing is right for you. __________________________________ INR


Take a stroll Stroll, meander, saunter, amble, promenade, wander, rambleâ&#x20AC;Ś.or a leisurely walk; all are a great sources of exercise.

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W

alkers have less incidence of cancer, heart disease, stroke, diabetes and other killer diseases. They live longer and get mental health and spiritual benefits. Basic changes in diet and exercise can lead to a dramatic drop in a person’s risk for chronic illnesses in as little as six weeks. Although the notion that proper nutrition and exercise is good for you is not an epiphany it’s important that people know that major health benefits can come quickly. Check first with your doctor or health care professional. Let them know you want to start a new walking program. Regardless of the potential benefits of exercise, your physician is the best judge of the appropriate exercise for you, considering your specific medical condition, stage of recovery or longterm treatment. Remember to ask about special nutritional needs once you start exercising. There may not be any to speak of, but once you change your normal physical routine, all considerations should be reviewed. Walking is one of the easiest and least expensive ways to exercise. Experts agree that you should get 30 minutes of moderate level physical activity on most days of the week ; walking is one of these activities. There are many health benefits of walking, such as reducing your risk of certain medical conditions (such as high blood pressure and heart disease), reducing depression, and helping you sleep better.

Physical activity is one of the cornerstones for good health, and walking is one of the easiest ways to be physically active. All you need is a good pair of shoes, and you can do it almost anywhere and at any time.

“Walking is man’s best medicine.” -Hypocrites Experts also agree that all you need is 30 minutes of moderate-level physical activity on most days of the week to see health benefits. Brisk walking is considered a type of moderate-level physical activity. You can even divide the 30 minutes into shorter periods of at least 10 minutes each. For instance, use stairs instead of an elevator, get off a bus one or two stops early, or park your car at the far end of the lot at work. If you already engage in 30 minutes of moderate-level physical activity a day, you can get added benefits by doing more. Engage in a moderate-level activity for a longer period each day, or engage in a more vigorous activity.


8

reasons to walk

Walking strengthens your heart. Mortality rates among retired men who walked less than one mile per day were nearly twice that among those who walked more than two miles per day. Women in the Nurse’s Health Study (72,488 female nurses) who walked three hours or more per week reduced their risk of a heart attack or other coronary event by 35% compared with women who did not walk.

Walking may prevent type 2 diabetes. The Diabetes Prevention Program showed that walking 150 minutes per week and losing just 7% of your body weight (12-15 pounds) can reduce your risk of diabetes by 58%.

Walking is good for your brain. Walking or other repetitive exercise can change the brain in a number of ways, says Dr. Gary Small, professor of psychiatry and aging at UCLA’s Semel Institute for Neuroscience and Human Behavior. The heart pumps more blood, affecting not only muscles but also the brain. “Your brain needs blood, because in the blood are nutrients and oxygen, which are good for the cells and will make the brain healthier,” he says. “The vessels that deliver the nutrients also branch out and become more effective.” The act of doing a movement over and over can also stimulate the brain’s neurocircuits, he adds, resulting in activity in various

regions of the brain. That activity may decrease over time as the body becomes more efficient at the activity. But other stimulation can have an effect -- while a person walks outside with a friend, for example, the brain is guiding a number of activities, such as talking and observing. In one study, stroke patients put through a walking program could walk better and faster afterward, and the repetitive movements also activated areas of their brain. Researchers expected to see most activity in the cortex, which governs motor skills, but instead much activity was seen in the subcortical region, which, says lead author Dr. Andreas Luft, “has some role in walking, but maybe we’ve underestimated it. We’re actually putting this idea back as a potential mechanism of how walking is controlled.” About half of 71 study subjects with some movement disability were asked to walk on a safety-rigged treadmill three times a week for up to 40 minutes, increasing intensity to a moderate level as the study progressed. The others did assisted stretching exercises for the same amount of time. All were tested in the beginning and after six months for speed and aerobic capacity; about half in each group were given functional magnetic resonance imaging tests before and after to determine brain activity. The walking group increased its speed by 51%, while the stretching group improved

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by 11%. The walkers’ fitness levels also increased, with aerobic capacity rising about 18%, while the stretching group’s fitness levels decreased slightly.

Walking is good for your bones. As we age, our bones thin out and become brittle, a condition known as osteoporosis. There are a number of ways to help prevent this condition, which can lead to broken bones and the myriad of serious health problems sometimes associated with them. One of the most effective preventative strategies is simply to take regular walks. “Weight-bearing exercise, in which your bones and muscles work against gravity, helps build and maintain bone mass,” says Dr. Tamara D. Rozental , orthopedic surgeon at Beth Israel Deaconess Medical Center and Instructor at Harvard Medical School. These are exercises in which the feet and legs bear your weight. “That’s where walking comes in,” she says. “It’s probably the easiest. Running and stairclimbing are also good, as is strength training with weights and weight machines that you find at a gym or health club. But walking for 20 to 30 minutes three times a week is just fine. It works.’’ Swimming and bicycling, by contrast, aren’t as effective in helping to prevent brittle bones. Dr. Rozental notes that bone is living tissue that responds to weight-bearing exercise by becoming stronger. It becomes stronger and denser as it is put under modest stress.

“Bone remodels in response to stress,” she says. “It is constantly being broken down and reformed.” In the case of osteoporosis, more bone is being broken down than is being formed, she notes. “With a sedentary lifestyle, bone thins,” she says. “Stress is necessary to stimulate the cells to form and remodel new bone.” There are other preventative strategies, such as taking Vitamin D and calcium supplements. And there are a number of prescription drugs, known as antiresorptive medications, which are also approved for the prevention and treatment of osteoporosis. Exercise is often an easy first-line strategy for prevention of brittle bones.

Walking helps alleviate symptoms of depression. Walking for 30 minutes, three to five times per week for 12 weeks reduced symptoms of depression as measured with a standard depression questionnaire by 47%. If you are currently on a medication for depression, walking is not a substitute and your prescribed medication must be continued until your physician says otherwise.

Walking reduces the risk of breast and colon cancer. Women who performed the equivalent of one hour and 15 minutes to two and a half hours per week of brisk walking had an 18% decreased risk of breast cancer compared with inactive women. Many studies have shown that exercise can prevent colon cancer, and if a person develops colon cancer,


the benefits of exercise appear to continue both by increasing quality of life and reducing mortality.

Walking improves general fitness. Walking just three times a week for 30 minutes can significantly increase cardiorespiratory fitness. Even in short amounts, walking has benefits. A study of sedentary women showed that short bouts of brisk walking (three 10-minute walks per day) resulted in similar improvements in fitness and were at least as effective in decreasing body fatness as long bouts (one 30-minute walk per day).

Walking improves physical function. Research shows that walking improves fitness and physical function and prevents physical disability in older persons. A body in motion tends to stay in motion. __________ What are the types of walking? There are two types of formal walking: power-walking (also known as speed-walking) and race-walking. Both types require technique; the difference between them is that race-walking is an Olympic sport with rules and power-walking is done more recreationally. For example, there’s a race-walking rule that the athlete’s back toe cannot leave the ground until the heel of the front foot has touched. Both are excellent forms of exercise that yield fitness and health benefits. Walking tips Over striding (lengthening your step) is biomechani cally inefficient and can slow you

down. It will burn more calories because it’s inefficient (which might be a good thing), but you may burn fewer calories overall because you don’t walk as far due to fatigue.

- To walk faster, concentrate on a powerful push off while the front foot lands closer to the body. This is what elite walkers do. - Walk heel to toe and not flatfooted to increase speed. Contact the ground with your heel. Roll the foot forward over the center of your foot. Push off with your toes. - Stand up straight. Leaning forward or back will slow you down and put unwanted pressure on the lower back. - Keep your hands relaxed and don’t make a fist. This should be relaxing. - Swing your arms forward and back and keep them close to your body. Speed up your arm swing to increase your speed and your legs will follow. - Keep your shoulders and neck relaxed. Your head should be upright. Is walking really a workout? A brisk walking can be almost as difficult as jogging. When you walk at speeds faster than 3 mph, your stride lengthens naturally which requires more arm and torso movement, which leads to increased torso and hip rotation, which amounts to higher aerobic demands and more calorie-burning. Research shows that at very high levels of exertion, oxygen consumption is only slightly


lower for race walkers than it is for runners. How many calories can walking burn? Moving burns calories, plain and simple. The intensity and duration of your walk determines caloric burn. A 170-pound man could burn 110 calories per mile; a 220-pound man may burn 140 calories per mile. You burn virtually the same number of calories whether you run or walk assuming your heart rate is similar; you just get there faster if you run.

care provider to help you improve your physical, mental and emotional fitness through walking. Happy walking. __________________________________ INR

Recommendations: The Surgeon General recommends 30 minutes or more of accumulated moderate intensity physical activity on five or more days per week to improve health and fitness. “Accumulated” means you can do it in shorter bouts throughout the day (for example, 10or 15-minute intervals throughout the day), and “moderate intensity” means you feel warm and slightly out of breath when you do it. The American College of Sports Medicine recommends 20-60 minutes of continuous activity, three to five times a week, at 60%90% of maximum heart rate, and two to three days of resistance training. Walking can accomplish this. Always consult your physician and keep them posted on your progress. Heart patients and those on long-term treatments for heart related condition should of course pay special attention to any activity that affects how the heart functions. Trust your health

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L

Heparin, the parent medication of Lovenox was discovered in 1916 and predates the establishment of the Food and Drug Administration of the United States, although it did not enter clinical

Lovenox®: The other blood thinner

Warfarin remains the most common antico-

agulant for long-term management of many heart conditions, but on occasion, other anticoagulants are needed temporarily for transitional use. Heparin and Lovenox are two medications that warfarin users often cross paths with. For warfarin patients, bleeding risks associated with surgical procedures can be of great concern. Warfarin is a slow acting medication, so when surgery is involved, other medications may become necessary to control bleeding or clotting which are common side effects of surgery. Physicians will closely monitor INR levels pre-op and post-op using additional anticoagulants to regulate the clotting process. Lovenox® (enoxaparin sodium) is a prescription medication approved for the prevention and treatment of blood clots. It is also approved to prevent complications in people who have recently had a heart attack or unstable angina ( a type of chest pain that may indicate that a heart attack is imminent). How Does Lovenox Work? Lovenox is a low molecular weight heparin medication. Like heparin, one of the oldest drugs in wide spread use, Lovenox works to prevent the formation of clots and may reduce the formation of new clots by binding to an enzyme in the body known as antithrombin III. Lovenox accelerates the activity of this enzyme. This action helps to reduce clot formation.

trials until 1935. One of the oldest drugs in wide use today, it is used to decrease the clotting ability of the blood and help prevent harmful clots from forming in the blood vessels. This medicine is sometimes called a blood thinner, although it does not actually thin the blood. Heparin will not dissolve blood clots that have already formed, but it may prevent the clots from becoming larger and causing more serious problems. Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions. It is used in low doses to prevent the formation of blood clots in certain patients, especially those who must have certain types of surgery or who must remain in bed for a long time. Heparin may also be used to diagnose and treat a serious blood condition called disseminated intravascular coagulation. Unlike other “blood thinners,” Lovenox does not break down clots. Instead, it slows down clot formation, giving the body a chance to break down the clots naturally. It is important to note that the two smallest strengths of Lovenox (the 30 mg and 40 mg strengths) come in pre-filled syringes that are not graduated. This means that the syringes do not have any measurement lines or any other way to adjust the dosage. The higher strengths of the pre-


filled syringes are graduated (they have measurement lines), meaning the dose may be adjusted as necessary. The most obvious difference between Coumadin® (warfarin) and Lovenox® is that Coumadin is taken by mouth, while Lovenox must be administered by subcutaneous injection (an injection just under the skin, much like insulin is injected). The second most obvious difference is that Lovenox is much more expensive than warfarin (on a dose-per-dose basis). Warfarin and Lovenox work in completely different ways. Warfarin is a vitamin K antagonist, while Lovenox is a low molecular weight heparin. Because Lovenox is not a vitamin K antagonist, there are no dietary restrictions (or food interactions) for Lovenox. While both medications may interact with other drugs that affect blood clotting and bleeding, warfarin is one of the most “interactive” drugs currently in use today -- meaning that it interacts significantly with a very large number of drugs. Lovenox is much less subject to drug interactions. Warfarin requires frequent monitoring of course whereas Lovenox usually requires no monitoring whatsoever, except in unusual circumstances. Lovenox is by no means a substitute for warfarin but is often used in conjunction with warfarin under the close supervision of your physician. Warfarin dosing is best managed through regular monitoring for safety and effective management. Lovenox dosing is simple and straightforward, with dosage adjustments almost never being required. Using Coumadin® and Lovenox together is quite common. This temporary partnership is referred to as “bridging” and may be used around a surgical procedure on long term warfarin patients to manage INR until post-surgical warfarin dosing is resumed. Lovenox begins working right away, while

Coumadin does not. In the period of time when a person first begins taking Coumadin, the drug may actually increase the risk of clots for a short period of time. Therefore, warfarin and Lovenox are often taken together. The Lovenox prevents clots while the warfarin begins working. The Lovenox can be stopped once the INR is in the appropriate range. A similar situation sometimes occurs in people who have been taking warfarin for a while. If a PT/INR test shows that the person is at a high risk for clots, a health care provider may recommend using Lovenox as a “bridge therapy” while the warfarin dose is being adjusted. ___________________________________ INR



INR Magazine May 2011