New study raises questions over broader use of statins

There is no evidence that using cholesterol-lowering statins can reduce the risk of death in people at high risk of cardiovascular disease (CVD) but without any prior history of CVD, a meta-analysis of previously published studies has concluded.

"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," the authors said.

"There is little debate that, compared with placebo, statin therapy among individuals with established coronary heart disease not only prevents complications related to atherosclerosis but also reduces all-cause mortality [death]," they added.

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 primary prevention (prevention of the development of heart disease).

In the meta-analysis, Kausik K. Ray, Sreenivasa Rao Kondapally Seshasai, and Sebhat Erqou, of University of Cambridge and Addenbrooke's Hospital, Cambridge, England, and colleagues combined data from 11 studies involving 65,229 participants.

A total of 32,623 individuals were assigned to take statins and 32,606 individuals were assigned to take placebo. Some data about participant deaths was obtained from the originally published studies, whereas in other cases, study investigators were contacted for updated information.

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.

The results of the current meta-analysis indicate the need for caution when extending the potential benefits of statins to a wider population.

The study has been published in the June 28 issue of Archives of Internal Medicine, one of the JAMA & Archives journals.