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

초록

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 ad-verse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglo-bin (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 mortali-ty 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 "re-sponder" 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.

키워드