薬理と治療

Abstract

Background　A special drug use-results survey was begun in September 2014 to investigate the safety and efficacy of the SGLT2 inhibitor dapagliflozin（Forxiga® Tablets）during long-term post-marketing use. Here, we report the final results of that survey. Methods　A special drug use-results survey was conducted in type 2 diabetes patients receiving dapagliflozin for the first time, with a maximum observation period of three years. The survey was conducted to explore the occurrence of adverse drug reactions（ADRs）designated as key investigation items and their risk factors, and to investigate factors that might affect safety and efficacy, etc., and the ADRs unexpected from the precautions for use and ADRs under actual drug use. Changes from baseline in HbA1c（NGSP）, fasting blood glucose, random blood glucose, body weight, body mass index, and blood pressure were investigated to evaluate efficacy. Results　The size of the safety population was 7581 patients, and that of the efficacy population was 7359 patients. ADRs were found in 981 patients（12.9％）, with the most frequent being pollakiuria in 70 patients（0.9％）and pruritus genital in 51 patients（0.7％）. Serious ADRs were seen in 135 patients（1.8％）, with those occurring in five or more patients being cerebral infarction in 12 patients（0.2％）, acute myocardial infarction in nine patients （0.1％）, dehydration in seven patients（0.1％）, angina pectoris in six patients （0.1％）, and colon cancer in five patients（0.1％）. The incidences of ADRs designated as priority survey items were 2.8％ for genital/urinary tract infection-related ADRs, 0.4％ for hypoglycaemia-related ADRs, 1.2％ for polyuria/pollakiuria-related ADRs, 1.2％ for fluid loss-related ADRs, 0.8％ for cardiovascular /cerebrovascular disease-related ADRs, 0.1％ for weight decreased -related ADRs, 1.0％ for skin disorder-related ADRs, 0.8％ for renal impairment-related ADRs, 0.7％ for hepatic function disorder-related ADRs, 0.6％ for ketone body increased-related ADRs, 0.3％ for malignant tumor-related ADRs, and 0.1％ for bone metabolism-related ADRs. Downward trends in HbA1c, fasting blood glucose, random blood glucose, body weight, body mass index, and blood pressure were found during the 36 months with administration of dapagliflozin. Conclusion　No apparent issues related to the safety profile of dapagliflozin were observed, and no particular efficacy-related concerns were found, during long-term post-marketing use for three years.