Safety and effectiveness of empagliflozin in clinical practice as monotherapy or with other glucose-lowering drugs in Japanese patients with type 2 diabetes: subgroup analysis of a 3-year post-marketing surveillance study

恩帕吉菲 医学 2型糖尿病 糖化血红素 血糖性 联合疗法 临床终点 内科学 不利影响 糖尿病 药理学 胰岛素 临床试验 内分泌学
作者
Kohei Kaku,Y. Nakayama,Junko Yabuuchi,Yusuke Naito,Keizo Kanasaki
出处
期刊:Expert Opinion on Drug Safety [Informa]
卷期号:: 1-14
标识
DOI:10.1080/14740338.2023.2213477
摘要

Background Sodium-glucose co-transporter-2 (SGLT2) inhibitors such as empagliflozin are increasingly prescribed as initial glucose-lowering drugs for type 2 diabetes (T2D), based on their cardiorenal benefits. However, information regarding the safety and the effectiveness of monotherapy with SGLT2 inhibitors in routine clinical practice is limited.Research design and methods We analyzed data from a prospective, 3-year, post-marketing surveillance study of empagliflozin in Japan. We evaluated adverse drug reactions (ADRs) (the primary endpoint) and glycemic effectiveness with or without other glucose-lowering drugs.Results 7931 T2D patients were treated with empagliflozin. At baseline, mean age was 58.7 years, 63.0% were male, and 1835 (23.14%) were not receiving other glucose-lowering drugs. ADRs occurred in 141 (7.68%) and 875 (14.62%) patients initiating empagliflozin as monotherapy or combination therapy, respectively. The most frequent ADRs of special interest with empagliflozin as monotherapy or combination therapy were urinary tract infections (0.82% and 1.14% of patients, respectively) and excessive/frequent urination (0.65%, 1.50%). At last observation, glycated hemoglobin level was reduced by a mean of 0.78% with empagliflozin monotherapy (from baseline mean of 7.55%) and 0.74% with combination therapy (baseline 8.16%).Conclusions Empagliflozin is well tolerated and effective in clinical practice in Japan when initiated as monotherapy or combination therapy.
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