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

摘要: © AbstractObjective To establish the effect of statins on muscle symptoms in people who had previously reported when taking statins. Design Series randomised, placebo controlled n-of-1 trials. Setting Primary care across 50 sites United Kingdom, December 2016 to April 2018. Participants 200 participants recently stopped or were considering stopping treatment with because symptoms. Interventions randomised a sequence six double blinded periods (two months each) atorvastatin 20 mg daily placebo. Main outcome measures At end each period, rated their visual analogue scale (0-10). The primary analysis compared symptom scores statin and periods. Results 151 provided for at least one period included analysis. Overall, no difference was found between (mean minus -0.11, 95% confidence interval -0.36 0.14; P=0.40)). Withdrawals intolerable 18 (9%) during 13 (7%) period. Two thirds those completing trial restarting long term Conclusions No overall severe Most intended restart N-of-1 trials can assess drug effects group level guide individual treatment. Trial registration ISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.