Brobst Morgane, Chapet Nicolas, Benchalkha Daylale, Bourgeois Elise, Herman Fanchon, Molinari Nicolas, Leclercq Florence, Pasquié Jean-Luc, Breuker Cyril, Sultan Ariane, Roubille François
Department of Pharmacy, CHU Montpellier, 34295 Montpellier, France.
Department of Pharmacy, CHU Montpellier, 34295 Montpellier, France.
Arch Cardiovasc Dis. 2025 Feb;118(2):85-92. doi: 10.1016/j.acvd.2024.10.332. Epub 2024 Dec 10.
Recommended treatment after acute coronary syndrome (ACS) involves high-intensity statin therapy to achieve the low-density lipoprotein (LDL-C) target of<1.4mmol/L (European guidelines), but many patients discontinue statins because of real or perceived side-effects. Whether body mass index (BMI) influences statin intolerance remains unclear.
To assess statin tolerance 3months after initiation, and to identify factors determining tolerance and persistence.
STATIC was a single-centre cohort study (November 2021 to April 2023) of patients admitted to cardiac intensive care units for ACS. The study had three stages: T0 (admission); W6 (6 weeks after ACS: statin efficiency); and M3 (3months after ACS: statin tolerance and persistence). SAMS score was used to evaluate imputability in patients reporting muscular side-effects. Multivariable analysis identified factors influencing tolerance; statin persistence was assessed using pharmacy dispensing data.
Overall, 289 patients were included (77.9% men; mean age 64.2years; 22.7% with BMI≥30kg/m). At T0, 38.1% had hypertension, 28.5% dyslipidaemia and 15.9% diabetes. At discharge, 269 patients received statins: 97.0% had a high-intensity statin; 43.5% had a statin/ezetimibe combination. At W6, mean LDL-C was 1.58mmol/L, with 45.5% at the LDL-C target. At M3, 6.0% reported side-effects (3.6% muscular, 1.2% liver, 1.2% gastrointestinal). Mean SAMS score was 5.67. No significant differences in muscular or hepatic side-effects were found between patients with BMI≥30 versus<30 kg/m. Persistence was 98.4% at M3 follow-up. The proportion of patients on a high-intensity statin or a statin/ezetimibe did not change from discharge to M3 (P=0.45 and P=1.00, respectively).
Statins are effective, but not always enough to reach LDL-C target. Tolerance and persistence were good, with muscular side-effects as expected, but without any guarantee of statin imputability. BMI did not influence statin tolerance in this study.
急性冠状动脉综合征（ACS）后的推荐治疗包括高强度他汀类药物治疗，以实现低密度脂蛋白（LDL-C）目标<1.4mmol/L（欧洲指南），但许多患者因实际或感知到的副作用而停用他汀类药物。体重指数（BMI）是否会影响他汀类药物不耐受尚不清楚。
评估开始治疗3个月后的他汀类药物耐受性，并确定决定耐受性和持续性的因素。
STATIC是一项单中心队列研究（2021年11月至2023年4月），研究对象为因ACS入住心脏重症监护病房的患者。该研究有三个阶段：T0（入院时）；W6（ACS后6周：他汀类药物疗效）；和M3（ACS后3个月：他汀类药物耐受性和持续性）。SAMS评分用于评估报告肌肉副作用患者的可归因性。多变量分析确定影响耐受性的因素；使用药房配药数据评估他汀类药物的持续性。
总体而言，纳入了289例患者（77.9%为男性；平均年龄64.2岁；22.7%的BMI≥30kg/m）。在T0时，38.1%的患者患有高血压，28.5%患有血脂异常，15.9%患有糖尿病。出院时，269例患者接受了他汀类药物治疗：97.0%接受高强度他汀类药物治疗；43.5%接受他汀类药物/依折麦布联合治疗。在W6时，平均LDL-C为1.58mmol/L，45.5%的患者达到LDL-C目标。在M3时，6.0%的患者报告有副作用（3.6%为肌肉副作用，1.2%为肝脏副作用，1.2%为胃肠道副作用）。平均SAMS评分为5.67。BMI≥30kg/m与<30kg/m的患者在肌肉或肝脏副作用方面未发现显著差异。在M3随访时持续性为98.4%。从出院到M3，接受高强度他汀类药物或他汀类药物/依折麦布治疗的患者比例没有变化（P分别为0.45和1.00）。
他汀类药物是有效的，但并不总是足以达到LDL-C目标。耐受性和持续性良好，肌肉副作用如预期，但不能保证他汀类药物的可归因性。在本研究中，BMI不影响他汀类药物耐受性。
