Ann Arbor, Mich. — A meta-analysis of previously published studies finds no evidence that statins are associated with a reduced risk of death among individuals at risk for but with no history of cardiovascular disease, according to a report in the June 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Lee A. Green, M.D., M.P.H, professor in the Department of Family Medicine, wrote a commentary published today in the Journal examining the findings of the meta-analysis.
“The meta-analysis makes it clear that in the short term, for true primary prevention, the benefit , if any, is very small,” says Green. “In the long term, we really must admit that we do not know.”
Statins are now one of the most widely used drugs for the treatment and prevention of cardiovascular disease both among individuals with established disease and among high-risk healthy individuals who are at elevated risk of incident [new-onset] cardiovascular disease, according to the study’s authors.
However, there is little evidence that statins reduce the risk of dying from any cause in individuals without heart disease. This, along with harms caused by statins in some subgroups, have called into question the benefit of statins in prevention of the development of heart disease, according to the study’s authors.
“The stakes in the debate that these articles enter are high,” Green says. “Most patients who have major coronary events do not have previously known disease, so primary prevention could deliver large benefits.
“Three-quarters of the patients who take statins are taking them for primary prevention, so enormous expenditures (from the payors’ perspective) or revenues ( from industry’s perspective) are at stake.”
In the meta-analysis, researchers looked at a total of 32,623 individuals who were assigned to take statins and 32,606 individuals who were assigned to take placebo.
Over an average of 3.7 years of follow-up, 2,793 participants died, including 1,447 assigned to take placebo and 1,346 assigned to take statins. This did not represent a statistically significant reduction in the risk of dying associated with statin use.
Low-density lipoprotein (LDL, or “bad” cholesterol) levels were higher among those taking placebo than those taking statins (134 milligrams per deciliter vs. 94 milligrams per deciliter). However, there was no association between risk of death and either LDL levels at the beginning of the study or average reduction in LDL levels.
“Current prevention guidelines endorse statin therapy for subjects at high global risk of incident cardiovascular disease as a means to reduce fatal and non-fatal vascular events,” the researchers concluded. The results of the current meta-analysis indicate the need for caution when extending the potential benefits of statins to a wider population. “Due consideration is needed in applying statin therapy in lower-risk primary prevention populations.”
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.