Minnesota Physician February 2014

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Statins for primary prevention from cover

“Pravastatin did not reduce total myocardial infarction or total stroke in the primary This article discusses five statins would be recommended prevention population, RR 0.94 or considered for millions of ad- trials that have formed the basis (0.78–1.14). … Measures of overfor much of the new guidelines. ditional people in the U.S. John all health impact in the comIt briefly describes each trial Ioannidis, MD, of the Stanford bined populations, total mortaland the study author’s main University School of Medicine, ity and total serious noted: “According to the adverse events, were ACC/AHA guidelines, of unchanged by prava– For primary prevention, there seems to be reasonable the 101 million people statin as compared evidence for high-risk men, 50–70 years of age, to use in the U.S. population to placebo, RR0.98 without cardiovascular statins … For all other patients … there is no compelling (0.84–1.14) and 1.01 disease and aged 40 (0.96–1.06), respecevidence to use statins for primary prevention. to 79 years, 33 million tively.” [“Therapeutics are expected to have a Letter #48 (April–June 10-year predicted risk of 2003)] demonstrated in RCTs. Most conclusion(s), and then looks cardiovascular disease of 7.5% ASCVD events occur after age at “the rest of the story”—the or higher (i.e., high-intensity 70 years, giving individuals >70 Statins for primary numbers behind the numbers— statins are recommended) and years of age the greatest potenprevention in women which needs to be considered in another 13 million are expected tial for absolute risk reduction.” The Anglo-Scandinavian Cardito have a predicted risk between evaluating the use of statins for [Stone et al., op cit., p. 18] ac Outcomes Trial–Lipid Low5% and 7.4% (i.e., statins should primary prevention. Arm (ASCOT-LLA) study ering The Prospective Study of be considered).” [Ioannidis J, was a randomized controlled Pravastatin in the Elderly at Statins for primary JAMA online, Dec. 2, 2013]. trial examining the use of Risk (PROSPER) trial (results prevention in the elderly As a family practitioner who statins for primary prevention published in 2002) examined Regarding global risk assesssees many patients who would in women. The 10,305 women the use of statins for primament for atherosclerotic cardiobe affected by the ACC/AHA in the study population were ry prevention in the elderly. vascular disease in the elderly, guideline, I am concerned about required to have hypertension PROSPER was a randomized the new ACC/AHA guideline both the conclusions and the plus three cardiac risk factors. controlled trial to test the benstates: “Some worry that a implications of the guideline and these trials.

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Minnesota Physician February 2014

person aged 70 years without other risk factors will receive statin treatment on the basis of age alone. The estimated 10-year risk is still >7.5%, a risk threshold for which a reduction in ASCVD risk events has been

efit of pravastatin treatment in an elderly cohort of men and women (aged 70–82) with, or at high risk of developing, cardiovascular disease and stroke. The study included 3,000 women and 2,804 men. It is worth noting that this trial included two populations: 56 percent primary prevention and 44 percent secondary prevention. Findings: Pravastatin decreased the risk of cardiovascular death by 24 percent in the pravastatin cohort.

Author’s conclusion: “Pravastatin given for 3.2 years reduced the risk of coronary disease in elderly individuals. PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle-aged people.” [Shepherd J et al. Lancet 360 (Nov. 23, 2002), 1623–30)] The rest of the story: This appears to be the only study designed to look exclusively at statins in an elderly population. With regard to primary prevention, an article reviewing randomized controlled trials of statin therapy noted of the PROSPER trial results:

As background, the authors stated: “The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (HD) in hypertensive patients who are not conventionally deemed dyslipidaemic.” [Sever PS, et al. Lancet 361 (2003): 1149–1158] Results: The study found that “in hypertensive patients, who on average were at moderate risk of developing cardiovascular events, cholesterol lowering with atorvastatin 10 mg conferred a 36% reduction in fatal CHD and non-fatal myocardial infarction compared with placebo.” The study was stopped after 3.3 years because of the positive outcome in the treatment arm. Author’s conclusion: “The reductions in major cardiovascular events with atorvastatin are large, given the short follow-up time. These findings may have implications for future lipid-lowering guidelines.” The rest of the story: Regard-


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