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薬理と治療
Abstract
Background and Objectives A long-term post-marketing prospective study was conducted to evaluate the safety and efficacy of the DPP-4 inhibitor anagliptin (brand name: SUINY®)in real-world clinical settings. Methods Patients with type 2 diabetes mellitus who were newly treated with anagliptin were included in this study. Adverse events, efficacy endpoints and others were surveyed using a central registry system. The observation period was three years from the start of anagliptin administration. Results According to the safety analysis set in 6324 patiets, the incidence of adverse drug reactions was 9.49%(600 patients), including hypoglycaemia(1.08%), constipation(0.81%), hepatic function abnormal(0.51%), hypertension(0.33%), renal impairment(0.28%), weight increased(0.25%), dizziness and blood urea increased(0.24% each), cerebral infarction and blood creatinine increased(0.21% each). The incidence of serious side effects was 1.85% (117 patients), including cerebral infarction(0.21%), death(0.09%), myocardial infarction (0.08%), gastric cancer and cerebral haemorrhage(0.06% each), pneumonia and colon cancer (0.05% each), appendicitis, breast cancer, decreased appetite, angina pectoris, atrial fibrillation, cardiac failure acute, cardiac failure congestive, interstitial lung disease, gastrointestinal haemorrhage and liver disorder (0.03% each). The efficacy of this drug was maintained up to three years, and the mean change in HbA1c at the final evaluation was -0.70±1.42(SD)%. onclusions No new safety or efficacy issues were observed during three years of use, suggesting that anagliptin is a useful treatment option for patients with type 2 diabetes mellitus.
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