Statins have no effect on survival rates in high-risk patients who do not have established cardiovascular disease, a comprehensive meta-analysis has demonstrated.

The huge meta-analysis published in Archives of Internal Medicine included eleven randomised, controlled trials involving 65,229 patients.

All the trials had collected information on all-cause mortality and included individuals without prevalent CVD at baseline.

The trials were identified by searching the MEDLINE and Cochrane databases for the period January 1970 to May 2009. The principal study was the West of Scotland Coronary Prevention Study (WOSCOPS) but other notable studies were included such as ALLHAT, AFCAPS/TexCAPS, ASCOT, CARDS and JUPITER.

If the final datasets included patients with established cardiovascular disease then the authors were contacted to allow the inclusion of just primary prevention patients. The cohorts did vary quite considerably with respect to recruitment strategy, mean age and cardiovascular risk profile.

The results showed that using statins over an average treatment period of 3.7 years was not associated with a significant reduction in all-cause mortality, risk ratio 0.91 (95% CI: 0.83-1.01).

The mean placebo mortality rate was 11.4 per 1,000 person-years which correlates to an intermediate- to

high-risk population and the authors estimated that taking statins resulted in only seven fewer deaths for every 10,000 person-years of treatment. These findings were independent of mean baseline LDL-cholesterol (LDL-C) and the mean LDL-C reduction in the treatment arms.

This was the largest analysis of statin therapy in a purely primary prevention setting and probably includes the totality of evidence available for primary prevention. However, it is important to consider that mortality rates are low in primary prevention trials and it is therefore difficult to show a mortality benefit.

It must also be remembered that the analysis looked at the short term, <4 years, benefit of statin therapy and it is possible that longer-term trials may reveal important benefits.

Statin use in these populations can significantly reduce the incidence of non-fatal cardiovascular events.

Therefore, from a practical perspective I would not necessarily look to statins to help people without established cardiovascular disease live longer but they might reduce the incidence of other, not necessarily fatal, outcomes such as MI and stroke and this may be just as important to our patients.

 

Dr Peter Savill

 

• Ray KK, Seshasai SRK, Erqou S et al. Statins and all-cause mortality in high-risk primary prevention. A meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med 2010; 170 (12):1024-31