In high-risk primary prevention situations, statin therapy may have no direct benefit on all-cause mortality, according to results of a meta-analysis published in the June 28 issue of the Archives of Internal Medicine.

“Statins have been shown to reduce the risk of all-cause mortality among individuals with a clinical history of coronary heart disease,” the authors wrote. “However, it remains uncertain whether statins have similar mortality benefit in a high-risk primary prevention setting.”

Kausik K. Ray, MD, and colleagues from the University of Cambridge and Addenbrooke Hospital in Cambridge, England, performed a meta-analysis of 11 prior studies—ASPEN, JUPITER, MEGA, ALLHAT, among others—conducted between January 1970 and May 2009 to evaluate whether or not statins had any effect on all-cause mortality.

The trials where identified using MEDLINE and Cochrane databases. Patients ages within the 11 trials ranged from 51 to 75 years old, zero to 68 percent were females and two trials—CARDS and ASPEN—enrolled diabetic patients, while the JUPITER trial excluded diabetics.

The researchers identified 65,229 patients—32,623 patients in the statin arm and 32,606 in the placebo arm—and evaluated whether or not statin use in primary prevention settings had the ability to reduce mortality.

These data showed that mortality rates across all studies varied from 3.6 to 26 per 1,000 person-years in the placebo arm of the studies (mean, 11.4) and 2.4 to 27.2 per 1,000 person-years in the statin arm (mean, 10.7). The researchers said that mortality rates varied by 66 percent.

Researchers found that a total of 2,794 deaths occurred—1,447 in the placebo arm and 1,346 deaths in the statin arm.

Additionally, the researchers looked at lipid levels and their correlation to all-cause mortality, but found that “no significant relationship was observed between mean baseline levels of LDL-C and the relative reduction in all-cause mortality across studies.”

"The present report suggests that all-cause mortality benefits are more modest in the short term, even among high-risk primary prevention populations, thereby indicating the need for further caution when extrapolating the potential benefits of statins on mortality to lower-risk primary prevention populations than to those shown herein," the authors concluded.