Barrons Robert
School of Pharmacy, 15543Wingate University, Wingate, NC, USA.
J Pharm Pract. 2023 Apr;36(2):383-393. doi: 10.1177/08971900211040291. Epub 2022 Jun 16.
Statin-associated autoimmune myopathy (SAAM) is a rare adverse event characterized by progressive muscle symptoms despite discontinuation, requiring immunosuppressive therapy for remission. The objective of this review was to characterize SAAM, for timely detection, while examining the literature for effective treatment considerations. PubMed search was conducted from 2010 to 2020 was for relevant case series and studies of at least 8 patients displaying muscle discomfort or weakness, anti-HMGCR antibodies, exposure to statins, and biopsies consistent with SAAM. Three case series and 3 case cohort studies identified 199 patients with SAAM. Exhibiting a mean age of 63.74 years, patients were more likely Caucasian (81%) and female (1.2X), and required a mean duration of 4.75 years before symptomatic. The presentation involved proximal muscle weakness (94%), myalgias (37%) and dysphagia (23%), accompanied by a mean creatinine kinase of 6383 IU/L. Most patients (57%) required 2 or more immunosuppressive (IMS) agents to achieve 62% remission. After 2 years of treatment, 15% of patients without remission reported symptomatic improvement, while another 12% were refractory to treatment. Delayed onset of SAAM greater than 4 years from statin initiation may create a low index of suspicion. However, progression of symptoms beyond 2 months from statin discontinuation and positive anti-HMGCR antibodies requires immunosuppressive agents. Data and expert opinion support use of at least two IMS medications upon diagnosis for a minimum of 2 years. Therapy success depends on timely recognition and initiation of IMS combinations to achieve earlier remission and symptomatic improvement.
他汀类药物相关的自身免疫性肌病(SAAM)是一种罕见的不良事件,其特征是即便停用药物后仍有进行性肌肉症状,需要免疫抑制治疗才能缓解。本综述的目的是对SAAM进行特征描述,以便及时发现,同时查阅文献以考虑有效的治疗方法。对2010年至2020年期间的PubMed进行检索,查找至少有8例表现出肌肉不适或无力、抗HMGCR抗体、使用过他汀类药物以及活检结果符合SAAM的相关病例系列和研究。三项病例系列和三项病例队列研究共确定了199例SAAM患者。患者平均年龄为63.74岁,更可能是白种人(81%)且为女性(比例为1.2倍),出现症状前的平均持续时间为4.75年。临床表现包括近端肌无力(94%)、肌痛(37%)和吞咽困难(23%),平均肌酸激酶为6383 IU/L。大多数患者(57%)需要两种或更多免疫抑制(IMS)药物才能达到62%的缓解率。治疗2年后,15%未缓解的患者症状有所改善,另有12%的患者对治疗无效。SAAM在开始使用他汀类药物4年多后延迟发作可能导致怀疑指数较低。然而,停用他汀类药物2个月后症状仍在进展且抗HMGCR抗体呈阳性,则需要使用免疫抑制剂。数据和专家意见支持在诊断时至少使用两种IMS药物,持续至少2年。治疗成功取决于及时识别并开始使用IMS联合治疗,以实现更早的缓解和症状改善。