Statin therapy questionable for low-risk CVD patients

Taylor F. Cochrane Database Syst Rev. 2011;doi:10.1002/14651858.CD004816.pub4.

The administration of statins for the primary prevention of CVD in patients with no previous history of the disease has come under question by researchers.

Using data from 14 trials that included 34,272 patients, researchers compared outcomes in patients given statins with those given placebos or routine care; eight of the 14 trials involving 28,161 patients provided data on all-cause mortality deaths, and 11 of the 14 provided data on specific conditions (raised lipids, diabetes, hypertension, microalbuminuria). Duration of treatment was a 1-year minimum with a minimum 6-month follow up.

Researchers reported that all-cause mortality was reduced by statins (RR=0.83; 95% CI, 0.723-0.95), and that fatal and nonfatal CVD endpoints were also lower (RR=0.70; 95% CI, 0.61-0.79). Statins were also associated with reduced revascularization rates (RR=0.66, 95% CI, 0.53-0.83) and a reduction in both LDL and total cholesterol. Researchers wrote that they did not find a direct correlation between statin use and adverse events in low-risk CVD patients.

Most of the trials included in the study reported composite outcomes, and one-third reported selected outcomes. Two of the largest studies included in the report were halted, according to researchers, because “significant reductions in primary composite outcomes had been observed.” No adverse events were reported in eight of the studies.

The findings indicate shortcomings in published trials of statins for primary prevention, the researchers wrote.

“Selective reporting and inclusion of people with CVD in many of the trials included in previous reviews of [the role of statins] in primary prevention make the evidence impossible to disentangle without individual patient data,” they wrote.

In an accompanying editorial, Carl Heneghan, BM, BCH, director of the Centre for Evidence-Based Medicine, University of Oxford, wrote that, “To date, only one trial has been publicly funded, while the authors of nine trials reported having been sponsored either fully or partially by pharmaceutical companies. … Although various multiple prevention strategies exist, the most effective for primary prevention in adults at low risk currently remains unclear.”

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