StatinWISE RCT Results: Do Statins Cause Muscle Pain?
BACKGROUND AND PURPOSE:
Evidence connecting statin use to muscle pain is limited; however, many patients will stop their medication for this reason
Herrett et al. (BMJ, 2021) investigate the effect of statins on muscle symptoms
Randomized, placebo-controlled ‘n-of-1’ trials
Patients who had stopped (within 3 years) or were considering stopping treatment with statins because of muscle symptoms
Exclusion: Elevated serum alanine aminotransferase (≥3 times the upper limit of normal)
A sequence of six double blinded treatment periods (two months each) of either atorvastatin 20 mg daily or placebo
Participants rated their muscle symptoms using a visual analogue scale after each treatment period
90% power | type I error of 5%
Treatment effect: At least one full unit on the visual analogue scale
Planned for 200 participants (assuming 40% loss to follow-up)
Muscle symptoms, on a visual analogue scale (0-10)
151 participants provided symptoms scores for at least one statin period and one placebo period
There was no difference in muscle symptom scores between the statin and placebo periods
Mean difference: −0.11 (95% CI, −0.36 to 0.14; P=0.40)
Withdrawals because of intolerable muscle symptoms
During a statin period: 9% (18 participants)
During a placebo period: 7% (13 participants)
Two thirds of participants that completed the trial reported restarting long term treatment with statins
The majority of participants who completed the trial decided to restart treatment with statins
The authors conclude
The lack of effect in patients completing the trial, combined with the low number of withdrawals owing to muscle symptoms, suggests a nocebo effect among users of statins, or of high tolerance to blinded rechallenge
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