Epidemiology and Preventive Pharmacology Service (SEFAP), Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy.
IRCCS MultiMedica, Milan, Italy.
J Intern Med. 2021 Jul;290(1):116-128. doi: 10.1111/joim.13219. Epub 2020 Dec 29.
Statin-associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients.
Demographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors.
Analyses were carried out on 16 717 statin-treated patients (mean ± SD, age 60.5 ± 12.0 years; 52.1% men). During statin therapy, 9.6% (N = 1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10-1.37] and OR 1.35 [1.14-1.60], respectively), whist age ≥ 65 (OR 0.79 [0.70-0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51-0.74]), use of concomitant nonstatin lipid-lowering drugs (OR 0.87 [0.76-0.99]), use of high-intensity statins (OR 0.79 [0.69-0.90]) and use of potential interacting drugs (OR 0.63 [0.48-0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort).
The reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation.
他汀类药物相关肌肉症状（SAMS）是导致治疗依从性差和/或停药的主要因素，但 SAMS 的明确诊断具有挑战性。PROSISA 研究是一项观察性回顾性研究，旨在评估血脂异常患者队列中报告的 SAMS 的患病率。
通过 23 家意大利脂质临床中心收集人口统计学/病史数据、生化值和 SAMS 的发生情况。采用调整后的逻辑回归估计报告 SAMS 的概率与几个因素之间的关联的比值比（OR）和 95%置信区间。
对 16717 例接受他汀类药物治疗的患者（平均±标准差，年龄 60.5±12.0 岁；52.1%为男性）进行了分析。在他汀类药物治疗期间，9.6%（N=1599）的患者报告了 SAMS。女性和运动活跃的患者更有可能报告 SAMS（OR 1.23[1.10-1.37]和 OR 1.35[1.14-1.60]），而年龄≥65 岁（OR 0.79[0.70-0.89]）、患有 2 型糖尿病（OR 0.62[0.51-0.74]）、使用非他汀类降脂药物（OR 0.87[0.76-0.99]）、使用高强度他汀类药物（OR 0.79[0.69-0.90]）和使用潜在相互作用的药物（OR 0.63[0.48-0.84]）与报告 SAMS 的可能性较低相关。在报告 SAMS 的患者中，82.2%进行了停药（治疗中断）和/或再挑战（改变或重新开始他汀类药物治疗），肌肉症状在 38.4%（整个队列的 3.01%）中再次出现。
PROSISA 队列中报告的 SAMS 患病率为 9.6%，但停药/再挑战后仍有三分之一的患者报告 SAMS。这些结果强调需要更好地管理 SAMS，以实施更准确的诊断和治疗再评估。
