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