Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance

• Published in: Diabetes & metabolism journal Vol. 47; no. 1; pp. 82 - 91
• Main Authors: Moon, Jun Sung, Kim, Nam Hoon, Na, Jin Oh, Cho, Jae Hyoung, Jeong, In-Kyung, Lee, Soon Hee, Mok, Ji-Oh, Kim, Nan Hee, Chung, Dong Jin, Cho, Jinhong, Lee, Dong Woo, Lee, Sun Woo, Won, Kyu Chang
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Diabetes Association 01.01.2023; 대한당뇨병학회
• Subjects: Body Weight; diabetes mellitus, type 2; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; empagliflozin; Glycated Hemoglobin; Humans; hypoglycemic agents; Hypoglycemic Agents - therapeutic use; Original; Product Surveillance, Postmarketing; Republic of Korea - epidemiology; sodium-glucose transporter 2 inhibitors; 내과학; Republic of Korea; Empagliflozin; Sodium-glucose transporter 2 inhibitors; Hypoglycemic agents; Product surveillance, postmarketing; Diabetes mellitus, type 2
• ISSN: 2233-6079; 2233-6087
• DOI: 10.4093/dmj.2021.0356

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.