Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
BMJ. 2021 Feb 24;372:n135. doi: 10.1136/bmj.n135.
To establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.
Series of randomised, placebo controlled n-of-1 trials.
Primary care across 50 sites in the United Kingdom, December 2016 to April 2018.
200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.
Participants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.
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.
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.
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.
ISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.
在先前因服用他汀类药物出现肌肉症状而报告肌肉症状的人群中，确定他汀类药物对肌肉症状的影响。
一系列随机、安慰剂对照的 n-of-1 试验。
2016 年 12 月至 2018 年 4 月，英国 50 个地点的初级保健。
200 名因肌肉症状而最近停止或正在考虑停止他汀类药物治疗的参与者。
参与者被随机分配到六次双盲治疗期（每个为期两个月）的序列中，每天服用阿托伐他汀 20 毫克或安慰剂。
在每个治疗期末，参与者使用视觉模拟量表（0-10）对其肌肉症状进行评分。主要分析比较了他汀类药物和安慰剂期的症状评分。
151 名参与者至少提供了一个他汀类药物期和一个安慰剂期的症状评分，并纳入主要分析。总体而言，他汀类药物期和安慰剂期的肌肉症状评分无差异（他汀类药物减去安慰剂的平均差异-0.11，95%置信区间-0.36 至 0.14；P=0.40））。由于无法耐受的肌肉症状，有 18 名参与者（9%）在他汀类药物期和 13 名（7%）在安慰剂期退出。完成试验的三分之二的人报告打算重新开始长期服用他汀类药物治疗。
在先前因服用他汀类药物而出现严重肌肉症状的参与者中，与安慰剂相比，阿托伐他汀 20 毫克对肌肉症状没有总体影响。大多数完成试验的人打算重新开始使用他汀类药物治疗。n-of-1 试验可以在群体水平上评估药物的效果，并指导个体治疗。
ISRCTN30952488、EUDRACT 2016-000141-31、NCT02781064。
