Nakamura Masato, Iizuka Tomoko, Sagawa Kei, Abe Kenji, Chikada Shuichi, Arai Miyuki
Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguroku, Tokyo, 153-8515, Japan.
Pharmacovigilance Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Cardiovasc Interv Ther. 2018 Apr;33(2):135-145. doi: 10.1007/s12928-017-0459-8. Epub 2017 Feb 17.
Data on prasugrel use in Japanese patients are limited to phase II/III clinical trials. This early postmarketing observational study evaluated the safety and efficacy of short-term prasugrel use in patients with acute coronary syndrome (ACS) in real-world clinical settings in Japan. From May 2014 to January 2015, we enrolled consecutive patients with ACS requiring percutaneous coronary intervention in each institution. Each patient started prasugrel treatment ≥1 month before the end of the study period. Safety outcomes included incidence rates of adverse drug reactions (ADRs) and bleeding adverse events (AEs). Efficacy outcomes were incidence rates of cardiovascular events (including major adverse cardiovascular events [MACE]). Case report forms were collected from 749 patients, 732 of whom were eligible for the safety and efficacy analysis sets. Approximately 95% of patients had a prasugrel loading/maintenance dose of 20 mg/3.75 mg/day. The incidences of ADRs and bleeding AEs were 8.6 and 6.4%, respectively. Twelve patients experienced major bleeding AEs; approximately 60% (seven patients) of which were gastrointestinal disorders. The incidence of bleeding AEs was significantly higher primarily in patients of female sex, aged ≥75 years, with low body weight (≤50 kg), severe cardiovascular disease, or severe renal impairment. The incidence of MACE was 1.9% during prasugrel treatment, and 3.1% at the end of the study period. This short-term study indicated that prasugrel treatment at loading/maintenance doses of 20 mg/3.75 mg/day was safe and effective in Japanese ACS patients in an acute setting.
This study is registered at http://www.umin.ac.jp/ctr/ under the identifier UMIN000014699.
关于普拉格雷在日本患者中的使用数据仅限于II/III期临床试验。这项早期上市后观察性研究评估了在日本真实临床环境中急性冠状动脉综合征（ACS）患者短期使用普拉格雷的安全性和有效性。2014年5月至2015年1月，我们在每个机构纳入了连续的需要经皮冠状动脉介入治疗的ACS患者。每位患者在研究期结束前≥1个月开始普拉格雷治疗。安全性结局包括药物不良反应（ADR）和出血不良事件（AE）的发生率。有效性结局是心血管事件（包括主要不良心血管事件[MACE]）的发生率。从749例患者中收集了病例报告表，其中732例符合安全性和有效性分析集的标准。约95%的患者普拉格雷负荷/维持剂量为20 mg/3.75 mg/天。ADR和出血AE的发生率分别为8.6%和6.4%。12例患者发生了主要出血AE；其中约60%（7例患者）为胃肠道疾病。出血AE的发生率主要在女性、年龄≥75岁、体重低（≤50 kg）、患有严重心血管疾病或严重肾功能损害的患者中显著更高。普拉格雷治疗期间MACE的发生率为1.9%，研究期结束时为3.1%。这项短期研究表明，在急性情况下，对于日本ACS患者，20 mg/3.75 mg/天的负荷/维持剂量的普拉格雷治疗是安全有效的。
本研究在http://www.umin.ac.jp/ctr/ 注册，标识符为UMIN000014699。
