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タイトル: Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes: A 52-week open-label study
著者: Inagaki, Nobuya  KAKEN_id
Kondo, Kazuoki
Yoshinari, Toru
Kuki, Hideki
著者名の別形: 稲垣, 暢也
キーワード: Canagliflozin
Sodium-glucose cotransporter 2 inhibitor
Type 2 diabetes mellitus
発行日: 1-Jan-2015
出版者: Asian Association of the Study of Diabetes (AASD) and Wiley Publishing Asia Pty Ltd
誌名: Journal of Diabetes Investigation
巻: 6
号: 2
開始ページ: 210
終了ページ: 218
抄録: Aims/Introduction: Canagliflozin is a sodium-glucose cotransporter 2 inhibitor under development for the treatment of type 2 diabetes. Our aim was to examine its efficacy and safety as monotherapy or in combination with commonly used oral antihyperglycemic drugs in Japanese patients with type 2 diabetes. Materials and Methods: Patients on diet/exercise alone or diet/exercise plus an oral antihyperglycemic drug (sulfonylurea, glinide, α-glucosidase inhibitor, biguanide, thiazolidinedione or dipeptidyl peptidase-4 inhibitor) were randomized to either 100 or 200 mg canagliflozin while continuing prior therapy. Patients were treated for 52 weeks in an open-label manner. Results: Canagliflozin significantly reduced hemoglobin A1c, fasting plasma glucose and bodyweight in all the study groups. Improvements were apparent by 4 weeks of treatment, and were maintained for 52 weeks. The reduction in hemoglobin A1c ranged from -0.80 to -1.06%, and from -0.93 to -1.26% in the 100 and 200 mg canagliflozin groups, respectively. Drug-related adverse events occurred in approximately one-third of patients, and included hypoglycemia/asymptomatic hypoglycemia and pollakiuria. Hypoglycemia/asymptomatic hypoglycemia was most common in patients treated with a sulfonylurea. Most adverse events were classified as mild or moderate in severity. Conclusions: The results of the present study confirmed that treatment with canagliflozin resulted in significant reductions in glycemic control and bodyweight that were maintained for 52 weeks of treatment irrespective of whether it was administered as monotherapy or in combination with another oral antihyperglycemic drug. Canagliflozin was well tolerated, with a low incidence of drug-related adverse events. This trial was registered with ClinicalTrials.gov (no. NCT01387737). Canagliflozin, a sodium-glucose co-transporter 2 inhibitor, significantly reduced hemoglobin A1c, fasting plasma glucose and body weight in Japanese patients with T2DM when used as monotherapy (100 or 200 mg over 52 weeks) in an open-label trial. Improvements were apparent by 4 weeks of treatment and were maintained for 52 weeks. Canagliflozin was well tolerated with a low incidence of drug-related adverse events.
著作権等: © 2014 The Authors. Journal of Diabetes Investigation published by Asian Association of the Study of Diabetes (AASD) and Wiley Publishing Asia Pty Ltd
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
URI: http://hdl.handle.net/2433/215208
DOI(出版社版): 10.1111/jdi.12266
PubMed ID: 25802729
出現コレクション:学術雑誌掲載論文等

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