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Annual Report 2009

DEFINING TOMORROW’S VASCULAR STRATEGIES


R3i International Steering Committee Name Pr Jean-Charles Fruchart President Pr Frank Sacks Vice-President Pr Michel Hermans General Secretary

Affiliation Pasteur Institute

City & Country Lille, France

Harvard School of Public Health

Boston, USA

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Pr Khalid Al-Rubeaan Pr Pierre Amarenco Pr Gerd Assmann Pr Bryan Brewer Pr Virgil Brown Pr John Chapman Pr Jean Davignon Pr Paul Dodson Pr Paula Fioretto Pr Henry Ginsberg Pr Dayi Hu Pr Takashi Kadowaki Pr Nikolaus Marx Pr Jesús Millán Núñez-Cortés Pr Jorge Plutzky Pr Robert S. Rosenson Pr Shaukat Sadikot Pr Evgeniy Shlyakhto Pr Piyamitr Sritara Pr Rody Sy Pr Paul Valensi Pr Christoph Wanner Pr Gerald Watts Pr Alberto Zambon Pr Jun-ren Zhu Pr Paul Zimmet

King Saud University University Paris-VII University of Münster Washington Hospital Center Emory University School of Medicine Hôpital Pitié-Salpêtrière Institut de Recherches Cliniques de Montreal Heart of England Foundation Trust University of Padua Columbia University People’s Hospital of Bejing University University of Tokyo RWTH Hospital General Universitario Gregorio Marañòn Harvard Medical School SUNY Downstate Medical Center Jaslok Hospital and Research Center Almazov Research Institute of Cardiology Mahidol University University of Philippines Paris-Nord University University Hospital University of Western Australia University of Padua Fudan University International Diabetes Institute

Riyadh, Saudi Arabia Paris, France Münster, Germany Washington, DC, USA Decatur, USA Paris, France Montreal, Canada Birmingham, UK Padua, Italy New York, USA Beijing, China Tokyo, Japan Aachen, Germany Madrid, Spain Boston, USA New York, USA Mumbai, India St Petersburg, Russia Bangkok, Thailand Manila, Philippines Bondy, France Würzburg, Germany Perth, Australia Padua, Italy Shanghai, China Caulfield, Australia


Table of Contents 2 4 6 10-12 14 18 19

Foreword – The Trustees Speak Out Our Three Pillars – Research, Advocacy, Education R3i Leadership R3i Clinical Trials Activities: MI/PROCAM & REALIST 2009 Outreach Activities Planned 2010 Programs 2009 Financial Summary

DEFINING TOMORROW’S VASCULAR STRATEGIES

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Foreword – The Trustees Speak Out The Residual Risk Reduction initiative (R3i), a Swiss-law Foundation, was founded in 2008 as a worldwide, academic, multidisciplinary, research driven, education focused, public advocacy, non-profit organization established by international researchers and clinicians. It is designed to help address the challenge of significantly improving and extending the lives of millions of patients with heart disease and/or diabetes by actively addressing the burden of residual vascular risk. As a starting point to all of our activities we have defined the concept of residual vascular risk as: “The significant residual risk of macrovascular events and microvascular complications which persists in most patients despite current standards of care including achievement of low-density lipoprotein (LDL-C) goal and intensive control of blood pressure and blood glucose.” • 1  7.5 million people die each year from CVD and 15 million people suffer strokes worldwide each year1,2 • 7  7 percent of the risk of heart attacks are still not prevented in patients treated by statin therapy, due to the residual vascular risk 3,4 • O  ne third of all people with diabetes develop nephropathy, representing approximately 60 million people worldwide5 • D  iabetes is among the leading causes of blindness, renal failure and lower-limb amputation. 23 million years of life, worldwide, are lost as a result of disability due to complications associated with diabetes.6 And, 50% of people with diabetes die of cardiovascular events.7 “Current treatment guidelines for dyslipidemia focus on reducing low-density lipoprotein cholesterol (LDL-C), with high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) considered secondary targets, but growing body of evidence suggests that LDL-C based treatments alone do not address the residual macroand microvascular risk despite optimal LDL-C treatment in accordance with current standards of care” – Pr. Jean-Charles Fruchart—President R3i 2


To address these issues, and the underlying unmet needs, we together with the R3i International Steering Committee and National Steering Committees members, developed a unique model built upon the principles of academic research, education and advocacy. We are happy to report that while much work remains on all fronts we are making real progress: • Research studies have been initiated that will provide new information about dyslipidemia and residual vascular risk • Nearly 400 opinion leaders in 48 countries have signed on to the challenge (202 National Steering Committee members and 156 National Faculty members) • Thousands of clinicians have been exposed to the R3i messages in 2009 through personal and non-personal venues at R3i meetings, congresses, and through the use of today’s modern communication technologies • Finally, encouraging first contacts were made with potential new grantors We strongly believe that if we continue to pursue all of these activities aggressively we will reach our goal of substantially extending and improving the lives of patients with heart disease and/or diabetes who have atherogenic dyslipidemia.

Pr. Jean-Charles Fruchart President Pasteur Institute, Lille, France

Pr. Frank Sacks Vice-President Harvard School of Public Health Boston, USA

Pr. Michel Hermans General Secretary Cliniques Universitaires Saint- Luc Brussels, Belgium

1. Atlas of Heart Disease and Stroke, WHO, September 2004. 2. Morrish NJ et al. Diabetologia 2001;44 Suppl 2:S14-S21. 3. Baigent C, Keech A, Kearney PM, et al, Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy and safety of cholesterol‐lowering treatment: prospective meta‐analysis of data from 90 056 participants in 14 randomised trials of statins. Lancet 2005;366:1267 1278. 4. Cholesterol Treatment Trialists’ (CTT) Collaborators, Kearney PM, Blackwell PM, Collins R, et al. Efficacy of cholesterol lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta analysis. Lancet 2008;371:117 125. 5. Fact Sheet Diabetes and Eye Disease. IDF. http://www.idf.org/fact-sheet-diabetes-and-eye-disease (Accessed November 2009) 6. International Diabetes Federation. Did you Know – The human, social and economic impact of diabetes [fact sheet on the Internet]. International Diabetes Federation, Brussels c 2008. [Last accessed 8th October 2008]. Available at: http://www.idf.org/home/index.cfm?node=41. 7. Diabetes and Kidney Disease: Time to Act. IDF, 2003.

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The Three R3i pillars – Research, Advocacy and Education The R3i vision

 To substantially extend and improve the lives of patients with heart disease and/or diabetes who have atherogenic dyslipidemia and remain at significantly increased risk of vascular diseases including myocardial infarction, impaired kidney function, loss of sight and limb amputation despite receiving current standards of care. Professor Sacks Research must be conducted to quantify the full extent of residual vascular risk in patients with atherogenic dyslipidemia (cholesterol abnormalities increasing vascular risk) and to identify new targets for therapeutic interventions. The results of this research must be disseminated broadly in all media, on a local and a global level, in order to generate appropriate impact. With this objective in mind, publications have already been submitted to several prestigious journals based on the MI/PROCAM results and the pilot study results from REALIST. Additionally, the results from REALIST will be presented at multiple Congresses in 2010.

Professor Fruchart Advocacy is required to ensure that the issue of residual vascular risk associated with atherogenic dyslipidemia is given appropriate priority in international and national guidelines, publications and other health media. That means reaching all key stakeholders in the healthcare community, particularly policy makers. Progress was made in this regard in 2009,

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starting with a press conference held to announce the results of a new analysis of the landmark PROCAM (Prospective Cardiovascular MĂźnster) Study and the early findings of The REALIST (REsiduAl risk LIpids and Standard Therapies) Survey at the European Society of Cardiology meeting in Barcelona. Through September 2009 over 240 articles in medical trade, news and finance business media were generated from these activities in 10 countries. Professor Hermans Educational programs are needed to create awareness of residual vascular risk and encourage healthcare professionals, particularly Primary Care Physicians (PCPs), to translate the results of research into improved treatment and management strategies. We understand the necessity to utilize all forms of modern media both personal and non-personal, in order to achieve our educational goals. Thus, the Foundation will continue to provide new tools to enable faculty to effectively reach target physicians and other healthcare professionals in their local communities as outlined in the 2010 R3i plan. Activities, including symposia and Meet the Experts sessions, are planned for numerous congresses in 2010.

DEFINING TOMORROW’S VASCULAR STRATEGIES

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R3i Leadership Representation Extends To 5 Continents and 48 Countries Expert representation that covers half the global population 16 of the top 25 nations by population (43.5% of global population) 48 nations representing a total of 51.2% of the global population (nearly 3.5B people)

Participating Countries: Algeria, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Ireland, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United States, and Vietnam. 6


R3i Foundation is a Worldwide Organization Designed for Local Impact

*Cardiology, diabetology, lipidology, endocrinology, ophthalmology, nephrology, epidemiology, basic science

DEFINING TOMORROW’S VASCULAR STRATEGIES

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MI/PROCAM

Extensive Research Program Underway To Gain New Insights Into Extent, Causes, and Intervention Strategies New analysis from MI (MI/PROCAM) demonstrates MI risk attached to low HDL-C or high TG is substantial in men, particularly in those with low LDL-C. • Low HDL-C and/or elevated triglycerides (TG) was seen in nearly two-thirds of MI patients • When all risks factors were matched, the odds of experiencing a MI were increased five-fold for men with LDL-C at target (≤100mg/dL) presenting a low level of HDL-C (<45 mg/dL) and an elevated level of TG (>150 mg/dL)

FPO

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Residual Cardiovascular Risk – A PROCAM SUBSTUDY Prevalence and Odds Ratios of HDL < 45 mg/dL and/or TG ≥ 150 mg/dL in Subgroups of LDL-C

LDL-C < 100 mg/dL LDL-C < 100-129 mg/dL LDL-C 130-159 mg/dL LDL-C ≥ 160 mg/dL

Prevalence MI Matched Patients Controls 76.1 38.8 61.8 36.2 63.5 42.2 66.3 50

Odds Ratio (95% CI) 5.0 2.9 2.4 2.0

(3.0 – 8.5) (1.9 - 4.3) (1.7 - 3.4) (1.4 - 2.8)

• The presence of either or both dyslipidemia is associated with a 2-fold increase in the odds ratio for MI in patients with LDL-C greater or equal to 160 mg/dL compared to similar controls. This odds ratio increased to 5 folds in men with LDL-C less than 100 mg/dL.

DEFINING TOMORROW’S VASCULAR STRATEGIES

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REALIST

Unique Epidemiological Research Underway Led by Professor Frank Sacks 1st worldwide study to establish the links between: • TG/HDL-C and risk of CVD events • TG/HDL-C and microvascular complications of Type 2 diabetes • Retrospective case control study based on chart reviews

Objectives: Establish the magnitude of atherogenic dyslipidemia in patients with: • A prior coronary event • Type 2 diabetes & microvascular complications • LDL-C goal achievement (with or without a statin) • Atherogenic dyslipidemia defined by low HDL-C or high triglycerides Assess relative risk (after adjustment for other risk factors) in patients at LDL-C goal with or without a statin: • Coronary events • Microvascular complications in Type 2 diabetes • Atherogenic dyslipidemia evaluated by continuous analysis of HDL-C and triglycerides, singly and jointly, and by recognized cut point

REALIST research program established in 48 centers worldwide (25 Macrovascular and 23 Microvascular Centers) with results to be published in 2010

REsiduAl risk,

LIpids and Standard Therapies 10


REALIST’s initial findings: First answers about atherogenic dyslipidemia and associated residual vascular risk The initial macrovascular findings of REALIST were presented by Professor Frank Sacks, Vice President of the R3i at the European Society of Cardiology meeting in Barcelona. This case control study was conducted in 170 patients hospitalized with CHD in Boston, MA, who were at goal for LDL-C. They were matched with 175 controls free from Coronary Heart Disease. The results demonstrate that: • High TG and low HDL-C are strong indicators of residual risk of CHD • High TG and low HDL-C levels each contribute to the risk of a coronary event in patients with LDL-C levels ≤130 mg/dL or even LDL-C ≤70 mg/dL • TG and HDL-C appear to act synergistically with the impact of TG increasing when HDL-C is low and the impact of HDL-C increasing when TG levels are high • When moving from the lowest levels of TG and highest levels of HDL-C to the highest levels of TG and lowest levels of HDL-C, the risk of CHD increases 10fold REALIST is also evaluating the risk of microvascular complications in patients with Type 2 diabetes who achieve or approach LDL-C goal. Data collected by Professor Michel Hermans were presented by Professor Paola Fioretto and showed that: • Low HDL-C, elevated TG and elevated non HDL-C levels were more prevalent in patients who developed microvascular complications • High TG levels are associated with increased risk of incident retinopathy, blindness and diabetic kidney disease • Low HDL-C levels are associated with incident diabetic kidney disease.

DEFINING TOMORROW’S VASCULAR STRATEGIES

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2009 Outreach Activity Results

International Exposure to the R3i Message is Growing Congresses and meetings expand R3i reach to over 1,100 clinicians • Global presence established with 8 meetings on 3 continents • National Faculties meetings held in Brussels and Bangkok attracted 210 clinicians representing nearly 40 countries • Scientific sessions (symposia and Meet the Experts sessions) provided an opportunity for peer-to-peer dialogue on residual vascular risk Congress

Date & Location

Metabolic Syndrome, Diabetes and Atherosclerosis Congress (MSDA)

May 20–24, Berlin

International Symposium on Atherosclerosis (ISA)

June 14-18, Boston

European Society of Cardiology (ESC)

August 29 –September 2, Barcelona

European Association for the Study of Diabetes (EASD)

September 30–October 2, Vienna

International Diabetes Foundation (IDF)

October 19-22, Montreal

American Society of Nephrology (ASN)

October 27–November 1, San Diego

American Heart Association (AHA)

November 15-17, Orlando

Asean Federation of Endocrine Societies (AFES)

November 28 –December 1, Bangkok

511 physicians attended one of the 26 “Meet the Experts” sessions organized by the R3i at its booth during 4 International Congresses

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Successful press coverage for R3i initiatives at ESC in Barcelona

• The R3i Multimedia News Release was viewed 658 times • The R3i website received over 800 visits immediately following the press conference • To date, 69 journalists from 24 countries have registered with the R3i press office • Through September 2009, over 240 articles were generated from ten countries over a one month period Articles Generated by Country Belgium

1

Brazil

1

France

1

Italy

1

Norway

1

Spain

1

Canada

3

UK

5

USA

220

International Publications

9

DEFINING TOMORROW’S VASCULAR STRATEGIES

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2009 Outreach Activity Results

Dramatic Increases in On-Line Program Participation in 2009 www.r3i.org Monthly website usage doubled in the past 4 months • Registered members total more than 4,000 in 110 countries • Website updated monthly with rich, timely editorial on R3i including: • Residual Risk through studies: presentations, and comments on main studies that reinforce the residual risk concept • “Focus On...”: presentations and comments on newly published articles • “Highlights”: short presentation of new published articles • Access to expert opinions on residual risk through short videos Strong commitment to education exhibited by R3i leadership • 43 R3i webinars (live web seminars) drew nearly 900 participants • Webinars have been chaired by 13 of the 29 International Steering Committee members

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Unique Interactive CME Programs (R3-vClinic) Designed to Simulate and Advance Patient Management • Multi-visit cases, focusing on residual vascular risk, present opportunities for Primary Care Physicians to enhance their diagnostic and patient management skills • Nearly 900 Healthcare Professionals from 51 countries have participated to date in this CME accredited program • Pre-test average scores were below 60%, documenting significant education needs • Educational effectiveness of the unique virtual patient programs was demonstrated by a 43% improvement in pre-test vs. post-test scores • Post-test results indicate that there are still significant learning gaps to be addressed by the R3i with regard to: — Use of diagnostic tools to assess residual vascular risk — Developing assessment plans for patients being treated with diabetes, hypertension, and dyslipidemia — Applying therapies to reduce cardiovascular residual risk factors in the context of primary and secondary prevention

DEFINING TOMORROW’S VASCULAR STRATEGIES

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Expansive 2010 Program to Address Research, Education, and Advocacy Development Planned Research Activities • Full scale and sub-analyses of REALIST • R3i grant: ACCORD-Lipid ancillary study

Education

Planned Education Activities Research • Slide kit updates

Advocacy

• Website updates focusing on video-based communication • Expanded webinar series Research

Residual • Brochures and educational tools targeting Primary Care Physicians Advocacy • Expansion of the Residual Risk Reduction Continuing Medical Education

• R3-vClinic Need to be R3i Colorized

D E F I N I N G T O M O R R O W ’ S VA S C U L A R S T R AT E G I E S

Planned Advocacy Activities Residual

• Meet-the-Experts sessions at key congresses D E F I N I N G T O M O R R O W ’ S VA S C U L A R S T R AT E G I E S • R3i’s perspective on the ACCORD trial results – interpretation and implications for the management of residual vascular risk Need to be R3i Colorized

Advocacy

• International Steering Committee meetings

• National Faculties meeting with 400 attendees in Athens (June 4-6, 2010) • Global and local publications including REALIST results Residual

D E F I N I N G T O M O R R O W ’ S VA S C U L A R S T R AT E G I E S

olorized 16


2009 Financial Report

Education 32%

International Congress Scientific Sessions 11% Management 12%

Advocacy 19%

International Steering Committee & Faculty Meetings 18%

Research 8%

The R3i Trustees gratefully acknowledge the generous support of the grantors who provided an unrestricted educational grant enabling the Foundation to launch a series of research and educational projects in 2008, and continue and expand upon those projects in 2009.

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The R3i Mission or â&#x20AC;&#x153;Join the R3iâ&#x20AC;?! The Residual Risk Reduction initiative (R3i) is a worldwide, academic, multidisciplinary, non-profit, Swiss-law Foundation established by international researchers and clinicians who recognize the importance of the high risk of fatal and non-fatal macro- and micro-vascular complications occurring in patients with atherogenic dyslipidemia who are already receiving the current standards of care. To address this issue, it engages healthcare professionals in an innovative global initiative of academic research, education and advocacy with the goal of significantly improving and extending the lives of millions of patients with heart disease and/or diabetes. Join us at www.r3i.org

R3i 2009 Annual Report  

The R3i vision—to substantially extend and improve the lives of patients with heart disease and/or diabetes who have atherogenic dyslipidemi...

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