Pedro-Botet Juan, Millán Núñez-Cortés Jesús, Chillarón Juan J, Flores-Le Roux Juana A, Rius Joan
a Unidad de Lípidos y Riesgo Vascular. Endocrinology and Nutrition Department , Hospital del Mar, Universidad Autónoma de Barcelona , Barcelona , Spain.
b Unidad de Lípidos , Hospital Universitario Gregorio Marañón, Universidad Complutense , Madrid , Spain.
Expert Opin Drug Saf. 2016 Dec;15(12):1583-1587. doi: 10.1080/14740338.2016.1238068. Epub 2016 Oct 24.
Statins are generally well tolerated, but muscular adverse effects appear to be the most common obstacle limiting their use. Our objective was to describe the severity of muscle injury (myalgia, myositis and rhabdomyolysis) and associated conditions related to statin therapy that may be clinically significant.
A cross-sectional one-visit, non-interventional, national multicenter study including patients of both sexes over 18 years of age referred for past or present muscle symptoms associated with statin therapy was conducted. Clinical, biochemical and drug therapy characteristics were obtained at the initial evaluation.
3,845 patients were recruited from a one-day record from 2,001 physicians. Myalgia was present in 78.2% of patients, myositis in 19.3% and rhabdomyolysis in 2.5%. The prevalence of different comorbidities such as diabetes, hypertension, atrial fibrillation, and coronary heart disease increased as the severity of myopathy rose. High-intensity statin therapy was used in 33.4% of patients. Concomitant drugs metabolized by the CYP450 3A4 pathway were taken by 9.3% of patients, and statins with this metabolic route by 75%. Independent variables associated with myositis or rhabdomyolysis compared with myalgia alone in the multivariate model were excessive alcohol consumption and pravastatin therapy.
Myalgia was the most common muscle adverse effect associated with statin therapy. Excessive alcohol consumption and pravastatin were independently associated with myositis or rhabdomyolysis.
他汀类药物一般耐受性良好，但肌肉不良反应似乎是限制其使用的最常见障碍。我们的目的是描述肌肉损伤（肌痛、肌炎和横纹肌溶解）的严重程度以及与他汀类药物治疗相关的可能具有临床意义的相关情况。
开展了一项横断面、单次就诊、非干预性的全国多中心研究，纳入年龄超过18岁、因既往或目前与他汀类药物治疗相关的肌肉症状前来就诊的患者，无论男女。在初始评估时获取临床、生化和药物治疗特征。
从2001名医生的一日记录中招募了3845名患者。78.2%的患者存在肌痛，19.3%存在肌炎，2.5%存在横纹肌溶解。随着肌病严重程度的增加，糖尿病、高血压、心房颤动和冠心病等不同合并症的患病率也随之上升。33.4%的患者使用高强度他汀类药物治疗。9.3%的患者服用通过CYP450 3A4途径代谢的伴随药物，75%的他汀类药物具有这种代谢途径。在多变量模型中，与单纯肌痛相比，与肌炎或横纹肌溶解相关的独立变量是过量饮酒和普伐他汀治疗。
肌痛是与他汀类药物治疗相关的最常见肌肉不良反应。过量饮酒和普伐他汀与肌炎或横纹肌溶解独立相关。
