他汀类药物治疗可有效预防动脉粥样硬化性心血管疾病，被广泛使用，但一直存在的担忧是他汀类药物治疗可能经常导致肌肉疼痛或无力。我们的目标是通过对他汀类药物治疗的大型、长期、随机、双盲试验中记录的所有肌肉不良事件的个体参与者数据荟萃分析来解决这些问题。

首次报告的肌肉疼痛或无力均无明显增加(0·99;96 - 1·0·02)。综合所有年份，与安慰剂相比，更密集的他汀治疗方案(即，40-80 mg阿托伐他汀或20-40 mg瑞舒伐他汀每天一次)产生了更高的RR(1.08[1.04 -1·13]vs 1.03[1.00 -1·05])，而更密集的治疗方案在1年后出现了少量的过量(1.05[0.99 - 1.12])。没有明确的证据表明不同的他汀类药物或在不同的临床情况下RR不同。

他汀类药物治疗引起了轻微的肌肉疼痛。在分配他汀类药物治疗的参与者中，大部分(>90%)的肌肉症状报告都不是由于他汀类药物所致。肌肉症状的小风险远低于已知的心血管益处。有必要回顾服用他汀类药物患者肌肉症状的临床管理。

Abstract

Background: Statin therapy is effective for the prevention of atherosclerotic cardiovascular disease and is widely prescribed, but there are persisting concerns that statin therapy might frequently cause muscle pain or weakness. We aimed to address these through an individual participant data meta-analysis of all recorded adverse muscle events in large, long-term, randomised, double-blind trials of statin therapy.

Methods: Randomised trials of statin therapy were eligible if they aimed to recruit at least 1000 participants with a scheduled treatment duration of at least 2 years, and involved a double-blind comparison of statin versus placebo or of a more intensive versus a less intensive statin regimen. We analysed individual participant data from 19 double-blind trials of statin versus placebo (n=123 940) and four double-blind trials of a more intensive versus a less intensive statin regimen (n=30 724). Standard inverse-variance-weighted meta-analyses of the effects on muscle outcomes were conducted according to a prespecified protocol.

Findings: Among 19 placebo-controlled trials (mean age 63 years [SD 8], with 34 533 [27·9%] women, 59 610 [48·1%] participants with previous vascular disease, and 22 925 [18·5%] participants with diabetes), during a weighted average median follow-up of 4·3 years, 16 835 (27·1%) allocated statin versus 16 446 (26·6%) allocated placebo reported muscle pain or weakness (rate ratio [RR] 1·03; 95% CI 1·01-1·06). During year 1, statin therapy produced a 7% relative increase in muscle pain or weakness (1·07; 1·04-1·10), corresponding to an absolute excess rate of 11 (6-16) events per 1000 person-years, which indicates that only one in 15 ([1·07-1·00]/1·07) of these muscle-related reports by participants allocated to statin therapy were actually due to the statin. After year 1, there was no significant excess in first reports of muscle pain or weakness (0·99; 0·96-1·02). For all years combined, more intensive statin regimens (ie, 40-80 mg atorvastatin or 20-40 mg rosuvastatin once per day) yielded a higher RR than less intensive or moderate-intensity regimens (1·08 [1·04-1·13] vs 1·03 [1·00-1·05]) compared with placebo, and a small excess was present (1·05 [0·99-1·12]) for more intensive regimens after year 1. There was no clear evidence that the RR differed for different statins, or in different clinical circumstances. Statin therapy yielded a small, clinically insignificant increase in median creatine kinase values of approximately 0·02 times the upper limit of normal.

Interpretation: Statin therapy caused a small excess of mostly mild muscle pain. Most (>90%) of all reports of muscle symptoms by participants allocated statin therapy were not due to the statin. The small risks of muscle symptoms are much lower than the known cardiovascular benefits. There is a need to review the clinical management of muscle symptoms in patients taking a statin.

Funding: British Heart Foundation, Medical Research Council, Australian National Health and Medical Research Council.

文章连接：

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01483-0/fulltext

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