| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Abe, Masanori Higuchi, Terumi Moriuchi, Masari Okamura, Masahiro Tei, Ritsukou Nagura, Chinami Takashima, Hiroyuki Kikuchi, Fumito Tomita, Hyoe Okada, Kazuyoshi |
| Description |
Author Affiliation: Abe M ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: abe.masanori@nihon-u.ac.jp.); Higuchi T ( Department of Nephrology, Keiai Hospital, Tokyo, Japan. Electronic address: thiguchi@keiai-hospital.jp.); Moriuchi M ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: mi.piace.hayden.v@gmail.com.); Okamura M ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: patrickemboma@yahoo.co.jp.); Tei R ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: haru_li_huang@yahoo.co.jp.); Nagura C ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: nagura.chinami@nihon-u.ac.jp.); Takashima H ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: craftsmanship.t.h@gmail.com.); Kikuchi F ( Department of Nephrology, Meirikai Chuo General Hospital, Tokyo, Japan. Electronic address: kikuchi5308@air.ocn.ne.jp.); Tomita H ( Department of Nephrology, Yujin Clinic, Tokyo, Japan. Electronic address: yjntomita@gmail.com.); Okada K ( Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: okada.kazuyoshi@nihon-u.ac.jp.) |
| Abstract |
AIMS: Saxagliptin is a dipeptidyl peptidase-4 inhibitor that was approved in Japan for the treatment of type 2 diabetes in 2013. We examined its efficacy and safety in Japanese hemodialysis patients with diabetic nephropathy. METHODS: In this prospective, open-label, parallel-group study, Japanese hemodialysis patients were randomized to receive either oral saxagliptin (2.5mg/day) or usual care (control group) for 24weeks. Before randomization, patients received fixed doses of conventional antidiabetic drugs (oral drugs and/or insulin) for 8weeks; these drugs were continued during the study. Endpoints included changes in glycated albumin (GA), hemoglobin A1c (HbA1c), postprandial plasma glucose (PPG), and adverse events. RESULTS: Both groups included 41 patients. Mean GA, HbA1c, and PPG decreased significantly in the saxagliptin group (-3.4%, -0.6% [-7mmol/mol], and -38.3mg/dL, respectively; all P<0.0001) but not in the control group (0%, -0.1% [-1mmol/mol], and -3.7mg/dL, respectively) (P<0.0001, P<0.001, and P<0.0001, respectively). In saxagliptin-treated patients, the reduction in GA was significantly greater when saxagliptin was administered as monotherapy than in combination therapy (-4.2% vs. -3.0%, P=0.012) despite similar baseline values (24.5% vs. 23.3%). Reductions in GA, HbA1c, and PPG were greater in patients whose baseline values exceeded the median (23.8% for GA, 6.6% for HbA1c, and 180mg/dL for PPG). There were no adverse events associated with saxagliptin. CONCLUSIONS: Saxagliptin (2.5mg/day) was effective and well tolerated when used as monotherapy or combined with other antidiabetic drugs in Japanese hemodialysis patients with type 2 diabetes. CLINICAL TRIAL REGISTRATION NUMBER: UMIN000018445. |
| File Format |
HTM / HTML |
| ISSN |
01688227 |
| Journal |
Diabetes Research and Clinical Practice |
| Volume Number |
116 |
| e-ISSN |
18728227 |
| Language |
English |
| Publisher |
Elsevier |
| Publisher Date |
2016-06-01 |
| Publisher Place |
Ireland |
| Access Restriction |
One Nation One Subscription (ONOS) |
| Subject Keyword |
Discipline Endocrinology |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Endocrinology, Diabetes and Metabolism Internal Medicine Endocrinology |
