Statins evidence: when answers also raise questionsBMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i4963 (Published 14 September 2016) Cite this as: BMJ 2016;354:i4963
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Statins and mortality
Dear Dr Godlee,
How do we resolve the dispute about the value of statins?  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  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.  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.
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
When prescribing a statin is being considered, patients should be advised that statins are a wonder drug in reducing cholesterol & cardiovascular disease. The secondary causes of hypercholesteroleamia should be excluded and a baseline serum creatine kinase measured and if raised then repeat after 3 days rest. Then take a history of muscle disorders and pain and fatigability. It is usual to start on either simvastatin or atorvastatin, which are both metabolised by the same pathway. Preferably start on the lowest dose & titrate up.
If a patient complains of muscle discomfort, immediately monitor serum creatine kinase and if raised repeat after 3 days rest. If normal or marginally raised, then the patient should be reassured. If raised then consider changing to a lower dose or another statin but not simvastatin or atorvastatin. Start the new statin on the lowest dose and titrate up. If the patient does not tolerate the new statin, then try another statin. The order to be tried is usually, rosuvastatin, pravastatin & fluvastatin.
However if serum creatine kinase exceeds 5 x upper limit normal (ULN), then discontinue the statin1. Monitor serum creatine kinase and exclude other causes of raised creatine kinase.
1.BNF 68, 2.12 Lipid lowering drugs, statin side effects. p 171
Competing interests: No competing interests