Bruckert Eric, Hayem Gilles, Dejager Sylvie, Yau Caroline, Bégaud Bernard
Department of Endocrinology, Hôpital de la Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris 83 Bd de L'Hôpital, 75 013, Paris, France.
Cardiovasc Drugs Ther. 2005 Dec;19(6):403-14. doi: 10.1007/s10557-005-5686-z.
To characterize the risk factors, rate of occurrence, onset, nature and impact of mild to moderate muscular symptoms with high-dosage HMG-CoA reductase inhibitor (statin) therapy in general practice.
The Prédiction du Risque Musculaire en Observationnel (Prediction of Muscular Risk in Observational conditions, PRIMO) survey was an observational study of muscular symptoms in an unselected population of 7924 hyperlipidemic patients receiving high-dosage statin therapy in a usual care, outpatient setting in France. Information on patient demographics, treatment history and muscular symptoms was obtained by questionnaires.
Multivariate analysis revealed the strongest predictors for muscular symptoms to be a personal history of muscle pain during lipid-lowering therapy (odds ratio, OR, 10.12, 95% CI 8.23-12.45; P < 0.0001), unexplained cramps (OR 4.14; 95% CI 3.46-4.95; P < 0.0001) and a history of creatine kinase (CK) elevation (OR 2.04; 95% CI 1.55-2.68; P < 0.0001). Overall, muscular symptoms were reported by 832 patients (10.5%), with a median time of onset of 1 month following initiation of statin therapy. Muscular pain prevented even moderate exertion during everyday activities in 315 patients (38%), while 31 (4%) were confined to bed or unable to work. Fluvastatin XL was associated with the lowest rate of muscular symptoms (5.1%) among individual statins.
PRIMO demonstrated that mild to moderate muscular symptoms with high-dosage statin therapy may be more common and exert a greater impact on everyday lives than previously thought. Knowledge of the risk factors for muscular symptoms will allow identification and improved management of high-risk patients. The risk of muscular symptoms with fluvastatin XL treatment may be lower than with high dosages of other statins.
在全科医疗中，对高剂量HMG - CoA还原酶抑制剂（他汀类药物）治疗导致的轻至中度肌肉症状的风险因素、发生率、起病情况、性质及影响进行特征描述。
“观察性条件下肌肉风险预测（PRIMO）”调查是一项针对法国门诊常规治疗中接受高剂量他汀类药物治疗的7924例血脂异常患者的未选择人群进行的肌肉症状观察性研究。通过问卷获取患者人口统计学信息、治疗史及肌肉症状信息。
多变量分析显示，肌肉症状的最强预测因素为降脂治疗期间肌肉疼痛的个人史（比值比，OR，10.12，95%置信区间8.23 - 12.45；P < 0.0001）、不明原因的痉挛（OR 4.14；95%置信区间3.46 - 4.95；P < 0.0001）及肌酸激酶（CK）升高史（OR 2.04；95%置信区间1.55 - 2.68；P < 0.0001）。总体而言，832例患者（10.5%）报告有肌肉症状，他汀类药物治疗开始后出现症状的中位时间为1个月。315例患者（38%）的肌肉疼痛甚至妨碍了日常活动中的适度运动，而31例（4%）只能卧床或无法工作。在各他汀类药物中，长效氟伐他汀导致肌肉症状的发生率最低（5.1%）。
PRIMO研究表明，高剂量他汀类药物治疗导致的轻至中度肌肉症状可能比之前认为的更常见，且对日常生活的影响更大。了解肌肉症状的风险因素将有助于识别高危患者并改善其管理。长效氟伐他汀治疗出现肌肉症状的风险可能低于高剂量的其他他汀类药物。
