Intended for healthcare professionals

Editorials

Adverse effects of statins

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3306 (Published 15 May 2014) Cite this as: BMJ 2014;348:g3306

Re: Adverse effects of statins

I was horrified to see that the BMJ was preparing to accede to Prof. Sir Rory Collins complaint regarding the extent of adverse reactions to statins based on his HPS study (Lancet 2003; 361: 2005–16). In this study, patient exclusion included a pilot study to test for tolerance. In short, the study rigorously excluded statin intolerants, potential intolerants and “non-compliants” (Why? Maybe because of prior adverse reactions). The results confirmed the effectiveness of these exclusion criteria with the absence of adverse reactions reported. But to extrapolate the idea of good tolerance based on these results to the general population is frankly poor science. The results of the HPS study can only applied to a population selected on the basis of the inclusion/exclusion criteria used in the study.

Furthermore, it is evident to anyone who read the paper that The HPS Study tried everyone on the drug and only the ones who didn't have side-effects were continued. This means that those individuals likely to have side effects were EXCLUDED!!.

Apart from this I found the original study to be flawed in other ways, principally the lack of evidence that it was cholesterol lowering was responsible for the benefits demonstrated, the avoidance of discussing the other pleiotropic actions of statins and the failure to identify the probability of benefit to the individual patient. In short, it was an infomercial to promote herd therapy (aka shotgun therapy) ignoring the potential of adverse reactions in many patients.

Competing interests: Sufferer of statin adverse reactions along with many others

28 May 2014
Michael J CAWDERY
retired research vet
none
Craigavon BT63 5TD