Department of Kinesiology, Université Laval, Québec, Québec, Canada.
Research Center of the University Institute of Cardiology and Pulmonology of Quebec, Québec, Québec, Canada.
PLoS One. 2023 Jun 14;18(6):e0281178. doi: 10.1371/journal.pone.0281178. eCollection 2023.
BACKGROUND AND AIMS: Statin-associated muscle symptoms (SAMS) are frequently reported. Nevertheless, few data on objective measures of muscle function are available. Recent data suggesting an important nocebo effect with statin use could confound such effects. The objective was to assess if subjective and objective measures of muscle function improve after drug withdrawal in SAMS reporters. METHODS: Patients (59 men, 33 women, 50.3±9.6 yrs.) in primary cardiovascular prevention composed three cohorts: statin users with (SAMS, n = 61) or without symptoms (No SAMS, n = 15), and controls (n = 16) (registered at clinicaltrials.gov, NCT01493648). Force (F), endurance (E) and power (P) of the leg extensors (ext) and flexors (fle) and handgrip strength (Fhg) were measured using isokinetic and handheld dynamometers, respectively. A 10-point visual analogue scale (VAS) was used to self-assess SAMS intensity. Measures were taken before and after two months of withdrawal. RESULTS: Following withdrawal, repeated-measures analyses show improvements for the entire cohort in Eext, Efle, Ffle, Pext and Pfle (range +7.2 to +13.3%, all p≤0.02). Post-hoc analyses show these changes to occur notably in SAMS (+8.8 to +16.6%), concurrent with a decrease in subjective perception of effects in SAMS (VAS, from 5.09 to 1.85). Fhg was also improved in SAMS (+4.0 to +6.2%) when compared to No SAMS (-1.7 to -4.2%) (all p = 0.02). CONCLUSIONS: Whether suffering from "true" SAMS or nocebo, those who reported SAMS had modest but relevant improvements in muscle function concurrent with a decrease in subjective symptoms intensity after drug withdrawal. Greater attention by clinicians to muscle function in frail statin users appears warranted. TRIAL REGISTRATION: This study is registered in clinicaltrials.gov (NCT01493648).
背景与目的:他汀类药物相关肌肉症状(SAMS)经常被报道。然而,关于肌肉功能的客观指标数据很少。最近的数据表明,他汀类药物使用中存在重要的反安慰剂效应,这可能会混淆这些效应。本研究的目的是评估 SAMS 报告者在停药后,肌肉功能的主观和客观测量是否改善。
方法:在一级心血管预防中,患者(59 名男性,33 名女性,50.3±9.6 岁)组成了三个队列:有症状的他汀类药物使用者(SAMS,n=61)或无症状的他汀类药物使用者(No SAMS,n=15)和对照组(n=16)(在 clinicaltrials.gov 注册,NCT01493648)。使用等速和手持测力计分别测量腿部伸肌(ext)和屈肌(fle)的力(F)、耐力(E)和功率(P)以及手握力(Fhg)。使用 10 分视觉模拟量表(VAS)自我评估 SAMS 强度。在停药前和停药后两个月进行测量。
结果:重复测量分析显示,停药后整个队列的 Eext、Efle、Ffle、Pext 和 Pfle 均有改善(范围+7.2%至+13.3%,均 p≤0.02)。事后分析显示,这些变化在 SAMS 中尤为明显(+8.8%至+16.6%),同时 SAMS 中对药物影响的主观感知下降(VAS,从 5.09 降至 1.85)。与 No SAMS(-1.7%至-4.2%)相比,SAMS 的 Fhg 也有所改善(+4.0%至+6.2%)(均 p=0.02)。
结论:无论是“真正”的 SAMS 还是反安慰剂,那些报告 SAMS 的患者在停药后肌肉功能有适度但相关的改善,同时主观症状强度下降。临床医生更加关注体弱的他汀类药物使用者的肌肉功能似乎是合理的。
试验注册:本研究在 clinicaltrials.gov 注册(NCT01493648)。
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