High Side-Effect Rates with Statins in Ordinary Practice but not in RCTs – the Enigma is Explained

Why do such a high proportion of patients who take statins complain of muscle pain in ordinary practice, while RCTs find little increase in this unintended effect? Could it be because the RCTs recruited a low-risk population? No – over 170,000 patients have been entered into high-quality RCTs, many had multi-morbidities and this was not a ‘sanitised’ population. Could it be because unintended effects were not assiduously recorded in RCTs? Again, no.

A recent paper in JAMA [1] examines re-introduction studies and find that the great majority of patients are able to tolerate treatment when it is restarted (admittedly, often in a different form). A particularly interesting study was carried out among people who had been ‘intolerant’ of statins. They were randomised to statin and non-statin treatments following a preparation phase where they were given placebo and could withdraw if intolerable symptoms recurred. Muscle pains were no more prevalent among those randomised to receive statins than among those in the non-statin group. It would appear that the very high incidence of muscle pain in standard practice is the result of psychological expectation, not pharmacological action. What do readers think?

— Richard Lilford, CLAHRC WM Director


  1. Newman CB, & Tobert JA. Statin Intolerance: Reconciling Clinical Trials and Clinical Experience. JAMA. 2015. 313(10); 1011-2.

One thought on “High Side-Effect Rates with Statins in Ordinary Practice but not in RCTs – the Enigma is Explained”

  1. Speaking as one who has taken the medication I experienced muscle pain as a consequence with no knowledge of the side effects. Hence do believe that it is a consequence of psychological expectations I believe is unfounded from my perspective. Having said that it makes an interesting study as I am sure psychological expectations are a certainty in many disciplines as a consequence of predicting an outcome in advance because it has already been stated as a likely outcome.

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