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

METHODS:

• Randomized, placebo-controlled ‘n-of-1’ trials
• Participants
  • 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)
• Interventions
  • A sequence of six double blinded treatment periods (two months each) of either atorvastatin 20 mg daily or placebo
• Study design
  • Participants rated their muscle symptoms using a visual analogue scale after each treatment period
• Sample size
  • 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)
• Primary outcome
  • Muscle symptoms, on a visual analogue scale (0-10)

RESULTS:

• 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

CONCLUSION:

• 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 

Learn More – Primary Sources:

Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials

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