Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Drug Safety Pub Date : 2025-06-18 DOI:10.1080/14740338.2025.2519835

Kazuhiro Yamamoto, Yusuke Naito, Sakurako Watanabe

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引用次数: 0

Abstract

Background: The sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin is approved in Japan for the treatment of heart failure (HF) with reduced left ventricular ejection fraction (HFrEF) and HF with preserved left ventricular ejection fraction (HFpEF). We conducted a post-marketing surveillance study of empagliflozin for HF in Japan.

Research design & methods: This was a 1-year prospective, multicenter, observational study of patients with chronic HF who had not previously received empagliflozin. The primary endpoint was incidence of adverse drug reactions (ADRs). Prespecified effectiveness endpoints were all-cause death, cardiovascular (CV) death, and hospitalization for HF (HHF).

Results: 1,166 patients were included (61.0% male, mean age 74.9 years). At baseline, mean left ventricular ejection fraction was 49.0%, mean body mass index was 24.2 ± 4.6 kg/m², and 34.2% had type 2 diabetes. ADRs occurred in 61 (5.2%) patients overall, 5.8% of those aged ≥ 75 years, 6.2% of those aged 65 to < 75 years, and 2.2% of those aged < 65 years. Incidences of all-cause death, CV death, and HHF were 3.0, 0.9, and 2.5 per 100 PY, respectively.

Conclusions: In this 1-year post-marketing surveillance study, empagliflozin was generally well-tolerated in patients with HF in Japan.

Trial registration: ClinicalTrials.gov identifier is NCT05262764.

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恩格列净在日本心力衰竭患者中的安全性和有效性：一项按年龄分层的1年上市后监测研究

背景：钠-葡萄糖共转运蛋白-2 （SGLT2）抑制剂恩格列净于2021年11月在日本被批准用于治疗左心室射血分数降低（HFrEF）的心力衰竭（HF），并于2022年4月被批准用于治疗左心室射血分数保留（HFpEF）的心力衰竭（HF）。我们在日本进行了一项恩帕列净用于心衰适应症的上市后监测研究。研究设计和方法：这是一项为期1年的前瞻性、多中心、观察性研究，研究对象为入组前未接受过恩格列净治疗的慢性心力衰竭患者。主要终点是药物不良反应（adr）的发生率。预先指定的有效性终点是全因死亡、心血管（CV）死亡和HF住院。结果：安全性分析集纳入1166例患者，其中61.0%为男性，平均年龄74.9岁。基线时平均左室射血分数为49.0%，平均体重指数为24.2±4.6 kg/m2, 34.2%合并2型糖尿病。总的来说，61例（5.2%）患者发生不良反应，年龄≥75岁的患者中发生不良反应的比例为5.8%，65岁的患者中发生不良反应的比例为6.2%。结论：在这项为期1年的上市后监测研究中，恩格列净在日本HF患者中普遍耐受良好。试验注册：ClinicalTrials.gov标识符为NCT05262764。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Safety 医学-药学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.