Ontology highlight
ABSTRACT: Objective
To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.Design
Series of randomised, placebo controlled n-of-1 trials.Setting
Primary care across 50 sites in the United Kingdom, December 2016 to April 2018.Participants
200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.Interventions
Participants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.Main outcome measures
At the end of each treatment period, participants rated their muscle symptoms on a visual analogue scale (0-10). The primary analysis compared symptom scores in the statin and placebo periods.Results
151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis. Overall, no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. Two thirds of those completing the trial reported restarting long term treatment with statins.Conclusions
No overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins. Most people completing the trial intended to restart treatment with statins. N-of-1 trials can assess drug effects at the group level and guide individual treatment.Trial registration
ISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.
SUBMITTER: Herrett E
PROVIDER: S-EPMC7903384 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Herrett Emily E Williamson Elizabeth E Brack Kieran K Beaumont Danielle D Perkins Alexander A Thayne Andrew A Shakur-Still Haleema H Roberts Ian I Prowse Danielle D Goldacre Ben B van Staa Tjeerd T MacDonald Thomas M TM Armitage Jane J Wimborne Jon J Melrose Paula P Singh Jayshireen J Brooks Lucy L Moore Michael M Hoffman Maurice M Smeeth Liam L
BMJ (Clinical research ed.) 20210224
<h4>Objective</h4>To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.<h4>Design</h4>Series of randomised, placebo controlled n-of-1 trials.<h4>Setting</h4>Primary care across 50 sites in the United Kingdom, December 2016 to April 2018.<h4>Participants</h4>200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.<h4>Interventions</h4>Participants were random ...[more]