Department of Medicine, Veterans Affairs Medical Center, Memphis, TN, USA.
J Clin Lipidol. 2011 Jul-Aug;5(4):299-307. doi: 10.1016/j.jacl.2011.05.005. Epub 2011 Jun 12.
Muscle pain without elevation of serum creatine phosphokinase (CPK) (myalgia) is the most common medication-related adverse effect of statin therapy; it occurs in up to 10% of patients who are prescribed statin therapy. Although much is known regarding risk factors for overt myositis, very few studies have provided information on this common form of statin intolerance.
We defined a detailed clinical and laboratory phenotype of a cohort of patients referred to the lipid clinic of a governmental health maintenance organization for statin intolerance attributable to muscle pain without CPK elevation (myalgia) and characterized their response to alternative lipid-lowering therapy. Baseline and follow-up data were analyzed for 104 patients with statin intolerance attributable to myalgia and 211 statin-tolerant control patients identified from the referral population.
Among patients with myalgia, more were white and had hypertension. The prevalence of known risk factors for overt myositis, including renal disease, type 2 diabetes mellitus, thyroid disease, and electrolyte abnormalities, did not differ between statin intolerant and statin tolerant patients. Although individual cases were identified in which the addition of interacting medications was temporally associated with development of statin intolerance, overall use of interacting medications was not more frequent among statin-intolerant patients. The majority of patients were intolerant of two or more statins; however, in more than one-half the cases, successful rechallenge with an alternative statin was accomplished. Despite this and extensive use of nonstatin lipid medications after lipid clinic referral, control of plasma lipoproteins remained significantly worse in statin-intolerant patients.
Statin intolerance attributable to myalgia is a significant barrier to effective treatment of hyperlipidemia. Conventional clinical risk factors for myositis do not appear to predictive of statin-associated myalgia. These findings underscore the need to better define the pathophysiology of statin-induced myalgia and develop methodologies to guide treatment of statin-intolerant patients.
肌肉疼痛而血清肌酸磷酸激酶（CPK）不升高（肌痛）是他汀类药物治疗最常见的药物相关不良反应；它发生在多达 10%接受他汀类药物治疗的患者中。虽然人们对肌炎的危险因素了解很多，但很少有研究提供这种常见的他汀类药物不耐受形式的信息。
我们定义了一个详细的临床和实验室表型，该表型是一个因肌肉疼痛而导致他汀类药物不耐受（肌痛）而被转诊到政府健康维护组织脂质诊所的患者队列，并描述了他们对替代降脂治疗的反应。对 104 例因肌痛而导致他汀类药物不耐受和 211 例从转诊人群中确定的他汀类药物耐受对照患者的基线和随访数据进行了分析。
在肌痛患者中，更多的是白人，且患有高血压。已知的肌炎显性危险因素的患病率，包括肾脏疾病、2 型糖尿病、甲状腺疾病和电解质异常，在他汀类药物不耐受和他汀类药物耐受患者之间没有差异。虽然个别病例中发现添加相互作用的药物与他汀类药物不耐受的发生在时间上有关，但他汀类药物不耐受患者的相互作用药物总体使用频率并不更高。大多数患者对两种或更多种他汀类药物不耐受；然而，在超过一半的病例中，成功地用替代他汀类药物进行了再挑战。尽管如此，并且在脂质诊所转诊后广泛使用非他汀类降脂药物，他汀类药物不耐受患者的血浆脂蛋白控制仍然明显较差。
因肌痛导致的他汀类药物不耐受是有效治疗高脂血症的一个重大障碍。传统的肌炎临床危险因素似乎不能预测与他汀类药物相关的肌痛。这些发现强调了需要更好地定义他汀类药物引起的肌痛的病理生理学，并开发指导他汀类药物不耐受患者治疗的方法。
