For many years, concern about statin (cholesterol lowering) drugs, their benefit, side effects, and the failure to prescribe a vitamin that prevents the development of its side effects has been rampant in the alternative medicine internet.
It appears the tide may be shifting, as a recent study reported in the AMA’s Archives of Internal Medicine found that cholesterol-lowering statin drugs does not reduce death in high-risk patients with no history of cardiovascular disease (CVD).
The researchers conducted an extensive review and analysis of studies involving 65,229 people.
The researchers performed a systematic review to identify randomized controlled trials of statin treatment for patients who were initially free of CVD. The lead author was Dr Kausik K. Ray of University of Cambridge, United Kingdom.
Over approximately 244,000 person-years of follow-up, there were 2,793 deaths. Primary prevention with statins was not associated with a reduced risk of all-cause mortality. The studies were similar.
A separate report conducted by French researchers, a “critical reappraisal” of the “Justification for the Use of Statins in Primary Prevention” (JUPITER) trial. That study, unlike other primary prevention studies, found a lower risk of cardiovascular disease in patients who were at first free of high cholesterol levels and heart disease. The lead author was Dr Michel de Lorgeril of Université Joseph Fourier and Centre National de la Recherche Scientifique, Grenoble, France.
However, the authors commented on numerous flaws—including the fact that the study was halted before 2 years of follow-up, despite the lack of significant differences in the most objective outcomes. Although nonfatal stroke and myocardial infarction were significantly reduced, there was no effect on mortality from these events. Heart disease deaths was lower than expected, including very low case-fatality from myocardial infarction. “The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study,” de Lorgeril and colleagues write.
Dr. Lee A. Green of University of Michigan Medical School, Ann Arbor, wrote an editorial response and discussed the implications for the use of lipid-lowering drugs for coronary primary prevention.
The new meta-analysis “makes it clear that in the short term, for true primary prevention, the benefit, if any, is very small,” Dr. Green writes.
He noted the need for long-term studies that are free of commercial bias.
Source: Arch Intern Med. 2010;170:1024-1031, 1032-1036, 1007-1008.