Atherosclerosis Unit, Department of Internal Medicine and Allied Medical Specialities, La Sapienza University, Rome, Italy.
Panminerva Med. 2012 Jun;54(2):105-18.
Large scale clinical trials have undoubtedly demonstrated that statins are effective in reducing cardiovascular events and all-cause mortality in almost all patient populations. Also the short and long-term safety of statin therapy has been well established in the majority of treated patients. Nevertheless, intolerance to statins must be frequently faced in the clinical practice. The most commonly observed adverse effects of statins are muscle symptoms and elevation of hepatic aminotransferase and creatinine kinase (CK) levels. Overall, myalgia (muscle pain with or without plasma CK elevations) and a single abnormally elevated liver function test constitute approximately two-thirds of reported adverse events during statin therapy. These side effects raise concerns in the patients and are likely to reduce patient's adherence and, consequently, the cardiovascular benefit. Therefore, it is mandatory that clinicians improve knowledge on the clinical aspects of side effects of statins and the ability to manage patients with intolerance to statins. Numerous different approaches to statin-intolerant patients have been suggested, but an evidence-based consensus is difficult to be reached due to the lack of controlled trials. Therefore, it might be useful to review protocols and procedures to control statin intolerance. The first step in managing intolerant patients is to determine whether the adverse events are indeed related to statin therapy. Then, the switching to another statin or lower dosage, the alternate dosing options and the use of non-statin compounds may be practical strategies. However, the cardiovascular benefit of these approaches has not been established, so that their use has to be employed after a careful clinical assessment of each patient.
大规模临床试验无疑表明,他汀类药物在几乎所有患者群体中都能有效降低心血管事件和全因死亡率。此外,他汀类药物治疗的短期和长期安全性在大多数接受治疗的患者中得到了很好的证实。然而,在临床实践中,必须经常面对他汀类药物不耐受的问题。他汀类药物最常见的不良反应是肌肉症状和肝转氨酶和肌酸激酶(CK)水平升高。总体而言,肌痛(有或无血浆 CK 升高的肌肉疼痛)和单次肝功能检查异常升高构成了他汀类药物治疗期间报告的不良事件的大约三分之二。这些副作用引起了患者的关注,并可能降低患者的依从性,从而降低心血管获益。因此,临床医生必须提高对他汀类药物副作用的临床方面的认识,并提高管理他汀类药物不耐受患者的能力。已经提出了许多针对他汀类药物不耐受患者的不同方法,但由于缺乏对照试验,很难达成基于证据的共识。因此,回顾控制他汀类药物不耐受的方案和程序可能会有所帮助。管理不耐受患者的第一步是确定不良事件是否确实与他汀类药物治疗有关。然后,可以采取换用另一种他汀类药物或较低剂量、交替剂量方案以及使用非他汀类化合物等实用策略。然而,这些方法的心血管获益尚未得到证实,因此,在对每位患者进行仔细的临床评估后,才能使用这些方法。