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Statins evidence: when answers also raise questions

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i4963 (Published 14 September 2016) Cite this as: BMJ 2016;354:i4963

Rapid Response:

Re: Statins evidence: when answers also raise questions

Statins and mortality

Dear Dr Godlee,

How do we resolve the dispute about the value of statins? [1] Of course large scale randomised clinical trials (RCTs) are the backbone of evidence and we should give due respect to analyses of interpretations of efficacy and safety by clinical trial and statistical experts. But this still leaves the debate open, given the selection of patients for such trials, the close monitoring for adverse events in the trials and the links to industry of most of the trialists. The recent review by Collins et al [2] provides a comprehensive summary of the randomised clinical trial data on the efficacy and safety of statin therapy. As a major aim of such therapy is to prevent myocardial infarction, the commonest cause of death in this population, the consumer is entitled to know whether statins will improve their life expectancy.

To answer this question we reviewed the main randomised statin clinical trial database to determine the overall effect on survival. Although many trials were not powered to detect an effect on overall mortality, when taken as whole, the database provides convincing evidence that there is little effect of statins on survival. There is a small benefit, but this is minimal compared to the benefit on average life expectancy conferred by not smoking. [3] Whether statin therapy prolongs life is more relevant for most people than the composites of cardiovascular death and vascular endpoints that were used to define efficacy in many of the trials.

Kind regards,

John B. Warren MD FRCP, Simon B. Dimmitt MBBS BMedSc(Hons) and Hans G. Stampfer MBBS

1. Godlee F. Statins: we need an independent review. The BMJ Sept 2016 www.bmj.com/content/354/bmj.i4992

2. Collins R et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; Sept 8, 2016 online. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31357-5/abstract

3. Warren JB, Dimmitt SB, Stampfer HG. Cholesterol trials and mortality. BJCP 2016;82:168-77.

Competing interests: No competing interests

28 September 2016
John B Warren
Physician
Simon B. Dimmitt MBBS BMedSc(Hons) and Hans G. Stampfer MBBS
Director, Medicines Assessment Ltd
London