CORRESPONDENCE: LETTER TO THE EDITOR
Trial Evidence for Statin-Based Primary Prevention Remains Dubious
Matthew F. Muldoon, MD, MPH*
* University of Pittsburgh, Center for Clinical Pharmacology, 506 Old Engineering Hall, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15260 (Email: mfm10{at}pitt.edu).
Although the primary prevention of atherosclerotic disease events by the use of statins is both widely promoted and commonly prescribed, Mills et al. (1) astutely note that the clinical trial evidence for this clinical practice is inconsistent. There has been a lack of compelling evidence that statins prevent cardiovascular events in initially healthy adults generally, and a near absence of trial evidence for treatment of hypercholesterolemia in women and the elderly.
Unfortunately, the meta-analyses and results presented by Mills et al. (1) can be questioned in several respects. First, although declaring exclusion of trials whose subjects included a large proportion with pre-existing coronary heart disease, the authors do include the entire PROSPER (Pravastatin in Elderly Individuals at Risk of Vascular Disease) sample even though 2,565 participants (44%) had pre-existing heart disease and the trial report provides results separately for the primary prevention arm (2). In addition, the meta-analysis includes 5 trials enrolling only patients with known clinical peripheral vascular disease or demonstrable carotid artery atherosclerosis. Finally, persons with diabetes are widely known to have a substantially higher risk for cardiovascular events than nondiabetic persons, yet the meta-analysis includes 2 large trials of diabetic patients. Trials testing the efficacy of statins in diabetic subjects are appropriately summarized elsewhere (3) and cannot be used to justify statin treatment in nondiabetic persons.
Mills et al. (1) could better advance this field by presenting analyses that more completely exclude evidence derived from patients with pre-existing atherosclerosis and diabetes. Furthermore, we still have no assembled evidence to justify prescribing statins to generally healthy women or elderly patients.
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1. Mills EJ, Rachlis B, Wu P, Devereaux PJ, Arora P, Perri D. Primary prevention of cardiovascular mortality and events with statin treatments: a network meta-analysis involving more than 65,000 patients J Am Coll Cardiol 2008;52:1769-1781.[Abstract/Free Full Text]2. Shepherd J, Blauw GJ, Murphy MB, et al. Pravastatin in Elderly Individuals at Risk of Vascular Disease (PROSPER): a randomised controlled trial Lancet 2002;360:1623-1630.[CrossRef][Web of Science][Medline] 3. Kearney PM, Blackwell L, Collins R, et al. Cholesterol Treatment Trialists' (CTT) Collaborators 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.[CrossRef][Medline]
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Reply
- Edward J. Mills and Philip J. Devereaux
J. Am. Coll. Cardiol. 2009 53: 2312-2313.
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