Department of Medicine, Kawasaki Medical School, Okayama, Japan.
Department of Cardiovascular Medicine, and Endocrinology and Metabolism, Faculty of Medicine, Tottori University, Tottori, Japan.
Expert Opin Drug Saf. 2022 Oct;21(10):1315-1328. doi: 10.1080/14740338.2022.2054987. Epub 2022 Mar 30.
Empagliflozin, a sodium-glucose co-transporter-2 inhibitor, was licensed for treating type 2 diabetes (T2D) in Japan and elsewhere in recent years. We conducted a post-marketing surveillance study of empagliflozin in Japan.
This was a 3-year, prospective, multicenter, observational study of the safety and effectiveness of empagliflozin in T2D patients in Japanese clinical practice who had not previously received this medication. The primary endpoint was the incidence of adverse drug reactions (ADRs).
Of 8145 patients enrolled from 1103 sites, 7931 received ≥1 dose of empagliflozin. Mean age was 58.7 years (10.5% aged ≥75), glycated hemoglobin (HbA1c) 8.0%, body mass index 28.1 kg/m (<20 kg/m in 2.1%); 63.0% were male and most had comorbidities (renal impairment in ~62%). Median treatment duration was 36.5 months. ADRs occurred in 1024 (12.91%) patients overall (serious ADRs in 2.09%) and 120 patients aged ≥75 years (14.46%). ADRs of special interest included hypoglycemia (0.44% of patients), urinary tract infections (1.07%), genital infections (0.66%), volume depletion (0.50%), diabetic ketoacidosis (0%), and lower limb amputation (0.04%). Overall mean change in HbA1c from baseline was -0.75%.
Empagliflozin is effective and generally well tolerated in Japanese patients, and ADRs are consistent with its known safety profile.
恩格列净是一种钠-葡萄糖协同转运蛋白 2 抑制剂，近年来在日本和其他国家获得批准用于治疗 2 型糖尿病（T2D）。我们在日本进行了恩格列净的上市后监测研究。
这是一项为期 3 年、前瞻性、多中心、观察性研究，评估了日本临床实践中未接受过该药物治疗的 T2D 患者使用恩格列净的安全性和有效性。主要终点是药物不良反应（ADR）的发生率。
从 1103 个地点共招募了 8145 名患者，其中 7931 名患者接受了至少 1 次恩格列净治疗。患者的平均年龄为 58.7 岁（10.5%年龄≥75 岁），糖化血红蛋白（HbA1c）为 8.0%，体重指数（BMI）为 28.1kg/m²（<20kg/m²的占 2.1%）；63.0%为男性，大多数患者存在合并症（约 62%存在肾功能损害）。中位治疗持续时间为 36.5 个月。总体上有 1024 名（12.91%）患者发生了 ADR（2.09%为严重 ADR），120 名年龄≥75 岁的患者发生了 ADR（14.46%）。特别关注的 ADR 包括低血糖（0.44%的患者）、尿路感染（1.07%）、生殖器感染（0.66%）、血容量减少（0.50%）、糖尿病酮症酸中毒（0%）和下肢截肢（0.04%）。从基线到总体平均 HbA1c 变化为-0.75%。
恩格列净在日本患者中有效且通常具有良好的耐受性，ADR 与已知的安全性特征一致。
