Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Diabetes Metab J. 2023 Jan;47(1):82-91. doi: 10.4093/dmj.2021.0356. Epub 2022 Jun 20.
To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.
This was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed.
The incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by -0.68%±1.39% and -1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a "responder" to empagliflozin therapy.
Empagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.
为了评估恩格列净在常规临床环境中的安全性和有效性，我们收集并评估了韩国 2 型糖尿病患者的临床特征。
这是一项恩格列净 10mg 和 25mg 的上市后监测研究。将不良事件和药物不良反应（ADR）信息作为安全性数据集进行收集。评估了包括糖化血红蛋白（HbA1c）水平、空腹血糖、体重和血压在内的可用疗效结局。
安全性数据集（n=3231）中 ADR 的发生率为 5.14%。多尿、生殖器瘙痒和体重减轻是最常见的 ADR。特别关注的 ADR 仅占 1.18%，且无导致死亡或住院的严重事件。在有效性数据集（n=2567）中，恩格列净在研究期间显著降低了平均 HbA1c 水平和体重，降幅分别为-0.68%±1.39%和-1.91±3.37kg（均 P<0.0001）。此外，较短的病程、无血脂异常和较高的基线 HbA1c 水平被确定为恩格列净治疗“应答者”的临床特征。
恩格列净在韩国 2 型糖尿病患者的常规治疗中是一种安全有效的降糖药物。预计在血糖控制不佳的韩国 2 型糖尿病患者中具有更好的降糖疗效。
