Chan Juliana C N, Kong Alice P S, Bao Weihang, Fayyad Rana, Laskey Rachel
Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin NT, Hong Kong SAR, China.
Pfizer Inc, New York, NY, USA.
Cardiovasc Ther. 2016 Dec;34(6):431-440. doi: 10.1111/1755-5922.12214.
Data on statin safety in Asian patients are limited compared with evidence from Western populations.
This study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials.
Data from 52 short-term trials (median exposure 4-72 weeks) and six long-term cardiovascular outcomes trials (median exposure 3.1-4.9 years) conducted across the atorvastatin 10-80-mg dose range were analyzed retrospectively to assess the incidence of safety endpoints.
A total of 77 952 patients were identified (49 974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short-term trials, the incidence of all-causality adverse events (AEs) and serious AEs (SAEs) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment-related AEs/SAEs were infrequent (2.0% across all doses). These observations were confirmed in the long-term trials. Treatment-related SAEs were rare (n = 4) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin-treated Asian patients, and the incidence of myalgia was 1.8% in the short-term studies and 6.7% in the long-term trials. Elevations (>3× the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal AEs occurred in <2%.
The incidence of AEs/SAEs with atorvastatin 10-40-mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80-mg is required owing to the limited number of Asian patients (n = 281; 11.2%) who received this dose.
与西方人群的证据相比，亚洲患者中他汀类药物安全性的数据有限。
本研究评估了参与58项随机临床试验的亚洲患者中阿托伐他汀的安全性。
回顾性分析了在10 - 80毫克剂量范围内进行的52项短期试验（中位暴露时间4 - 72周）和6项长期心血管结局试验（中位暴露时间3.1 - 4.9年）的数据，以评估安全性终点的发生率。
共识别出77952例患者（49974例接受阿托伐他汀治疗），其中3191例为亚洲患者（2519例接受阿托伐他汀治疗）。在短期试验中，接受阿托伐他汀治疗的亚洲患者中全因不良事件（AE）和严重不良事件（SAE）的发生率与其他他汀类药物或安慰剂相似或更低，因治疗相关AE/SAE而停药的情况很少见（所有剂量组均为2.0%）。这些观察结果在长期试验中得到了证实。接受阿托伐他汀治疗的亚洲患者中与治疗相关的SAE很少见（n = 4）。在接受阿托伐他汀治疗的亚洲患者中未观察到横纹肌溶解病例，短期研究中肌痛发生率为1.8%，长期试验中为6.7%。接受阿托伐他汀治疗的亚洲患者中约2%观察到肝转氨酶升高（>正常上限3倍）；肾脏AE发生率<2%。
亚洲裔患者使用10 - 40毫克阿托伐他汀时AE/SAE的发生率较低，与安慰剂相当。由于接受80毫克剂量的亚洲患者数量有限（n = 281；11.2%），需要对80毫克阿托伐他汀进行进一步评估。
