高齢者2型糖尿病に対するダパグリフロジンの 安全性および有効性の検討ーダノ V°グリフロジン特定使用成績調査結果の中間報告一

摘要

Objectives To investigate the safety and efficacy of dapagliflozin in elderly patients with type 2 diabetes. Methods An observational study (September 2014 through April 2016) has been conducted in type 2 diabetes patients aged>65 years who took dapagliflozin for the first time within the 3 months after its launch in Japan. Data collected included patient background at start of administration of dapagliflozin, exposure, occurrence of serious adverse events, adverse reactions/ infections with particular emphasis on genital/urinary tract infections, hypoglycemia, pollaki-uria, polyuria, body fluid volume depletion, and cofounding factors as well as efficacy. Results Adverse reactions/infections were observed in181(11.1%) of the 1631 patients included in the safety population. The incidence of adverse drug reactions was higher in patients aged>75 years (>75 toく80:15.3% and>80: 14.1%) compared to patients agedく 75 years (>65 toく70: 9.0% and>70 toく75: 9.9%). Adverse reactions possibly related to genital/urinary tract infections were seen in 35 patients (2.1%), hypoglycemia in five patients (0.3%), pollakiuria and polyuria in18 patients (1.1%), body fluid volume depletion in13 patients (0.8%), cardiovascular/cerebrovascular disease in four patients (0.2%), and skin reactions in 25 patients U.5%). These incidences were not largely different compared with past reports, and no new safety-related issues were identified. Efficacy results (e. g.， effect on blood sugar and body weight) were also similar to previously reported trends. Conclusions The adverse events seen in this observational study were consistent with the known profile of dapagliflozin and no new safety concerns were raised in this observational study in elderly patients with type 2 diabetes.