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저자정보
문준성 (영남대학교) 김남훈 (고려대학교) 나진오 (고려대학교) 조재형 (가톨릭대학교) In-Kyung Jeong (Department of Endocrinology and Metabolism Kyung Hee University Hospital at Gangdong Kyung Hee University School of Medicine Seoul 05278 Korea.) 이순희 (인제대학교 부산백병원) 목지오 (순천향대학교) 김난희 (고려대학교) 정동진 (전남대학교) 조진홍 (Boehringer Ingelheim Korea) 이동우 (Boehringer Ingelheim Korea) 이선우 (Boehringer Ingelheim Korea) 원규장 (영남대학교)
저널정보
대한당뇨병학회 Diabetes and Metabolism Journal Diabetes and Metabolism Journal Vol.47 No.1
발행연도
2023.1
수록면
82 - 91 (10page)
DOI
10.4093/dmj.2021.0356

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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.

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