Duration and magnitude of the effect of a single statin tablet in primary prevention of cardiovascular events

Abstract

Background: Many preventative steps are recommended for both regular and opportunistic use. However statins are recommended exclusively for lifelong use: opportunistic uptake is blocked by lack of evidence of benefit.

Method: This manuscript presents and applies a method of quantifying cardiovascular event prevention from a single statin tablet, using data from trials of regular administration. It calculates sample sizes required for direct experimental verification.

Results: The progressive growth of relative-risk reduction is shown to directly reflect progressive delivery of prevention from the first tablet. Regular-administration trial data expose the time course of preventative effect of a single tablet. From 90,056 patients' trial data, event-prevention of a single statin tablet is found to develop gradually over one year. Each tablet of (modest) statin gives 0.137% relative reduction in annual mortality over one year. For an average 60-year-old UK man, absolute mortality reduction is 143 millionths of a percent (47 times larger than the survival benefit of him wearing a seatbelt once). Verification by 1-year trial would need 300 million subjects. A 1-month trial would need 4 billion, the majority of the world's population.

Conclusion: It is patient, but innumerate, to await direct trial evidence of opportunistic primary prevention by one statin tablet. Regular-administration trials show that each tablet delivers event reduction gradually over 1 year. Although the absolute death reduction seems small, for men over 35 it is larger than death reduction from wearing a seatbelt for a car journey. Physicians currently encourage opportunistic uptake of exercise, but not statins. Opportunistic pharmaceutical prevention should not be rejected without more valid grounds than lack of explicit trials.