Diabetes Metab J.  2023 Jan;47(1):82-91. 10.4093/dmj.2021.0356.

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

• Moon JS
• Kim NH
• Na JO
• Cho JH
• Jeong IK
• Lee SH
• Mok JO
• Kim NH
• Chung DJ
• Cho J
• Lee DW
• Lee SW
• Won KC

• KMID: 2538933
• DOI: http://doi.org/10.4093/dmj.2021.0356

Abstract

Background
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.
Methods
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.
Results
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.
Conclusion
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.

Keyword

Diabetes mellitus, type 2; Empagliflozin; Hypoglycemic agents; Product surveillance, postmarketing; Sodium-glucose transporter 2 inhibitors

Figure

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  Fig. 1. Flow diagram of the analyzed population in the Korean post-marketing surveillance. The safety analysis set was completed by excluding subjects who were duplicated (one case), subjects who did not take the study drug (11 cases), subjects with follow-up failure (six cases), and subjects with inclusion/exclusion criteria violations (119 cases). The effectiveness analysis set was completed by excluding subjects whose glycosylated hemoglobin (HbA1c) levels before or after administration of the study drug were not recorded (235 cases); subjects whose HbA1c levels before or after administration of the study drug were unknown (429 cases). eCRF, electronic case report form.

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  Fig. 2. The number of reported subjects with adverse drug reactions by system organ class.

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