Single-Patient Studies Test Statin-Related Myalgia

March 03, 2014

LONDON, ON — Are a patient's aches and pains truly related to the statin or are they the result of other causes? Differentiating statin-related myalgia from general muscle pain can be difficult, so a group of Canadian researchers propose small, single-patient trials to determine whether patients are in fact experiencing side effects from the lipid-lowering therapy[1].

When exposing eight patients to several double-blind statin and placebo challenges, none had a statistically significant difference in myalgia or other pain measures on the statin compared with placebo. Most of the patients, say the investigators, restarted their statin after reviewing the study results.

These so-called n-of-1 trials are a "potentially useful tool to examine myalgia caused by statin rechallenge in selected patients," write Dr Tisha Joy (University of Western Ontario, London) and colleagues in their study, published in the March 4, 2013 issue of the Annals of Internal Medicine.

The eight patients, including seven women, all of whom were at high cardiovascular risk, were randomly exposed to a maximum of three statin and placebo treatments lasting for three weeks. Treatment periods were separated by a three-week washout period. The dose of statins used were the same as those previously associated with myalgia.

None of the patients had significantly more symptoms of myalgia during statin treatment than on placebo. Five patients resumed their statin after reviewing the results with their physician (one patient had LDL-cholesterol levels at target and did not resume treatment). Starting the statin following the trial lowered the mean LDL-cholesterol level from 148 mg/dL to 70 mg/dL in the five patients.

These n-of-1 trials can limit physician and patient bias that can be associated with open-label statin use, say Joy and colleagues. They add that statin-related myalgia lacks an objective biomarker or test to distinguish it from general muscle aches or pains, so an n-of-1 study can be helpful to determine whether a patient can be successfully rechallenged with a statin.


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