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Hokkaido University Collection of Scholarly and Academic Papers >
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Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes : a 3-year prospective, controlled, observational study (J-BRAND Registry)
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| Title: | Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes : a 3-year prospective, controlled, observational study (J-BRAND Registry) |
| Authors: | Ueki, Kohjiro Browse this author →KAKEN DB | | Tanizawa, Yukio Browse this author →KAKEN DB | | Nakamura, Jiro Browse this author →KAKEN DB | | Yamada, Yuichiro Browse this author | | Inagaki, Nobuya Browse this author →KAKEN DB | | Watada, Hirotaka Browse this author →KAKEN DB | | Shimomura, Iichiro Browse this author →KAKEN DB | | Nishimura, Rimei Browse this author | | Miyoshi, Hideaki Browse this author →KAKEN DB | | Abiko, Atsuko Browse this author | | Katagiri, Hideki Browse this author →KAKEN DB | | Hayashi, Michio Browse this author | | Shimada, Akira Browse this author →KAKEN DB | | Naruse, Keiko Browse this author | | Fujimoto, Shimpei Browse this author →KAKEN DB | | Fujiwara, Masazumi Browse this author | | Shikata, Kenichi Browse this author | | Okada, Yosuke Browse this author | | Araki, Eiichi Browse this author →KAKEN DB | | Yamazaki, Tsutomu Browse this author | | Kadowaki, Takashi Browse this author →KAKEN DB |
| Issue Date: | 2021 |
| Journal Title: | BMJ Open Diabetes Research & Care |
| Volume: | 9 |
| Issue: | 1 |
| Start Page: | e001787 |
| Publisher DOI: | 10.1136/bmjdrc-2020-001787 |
| Abstract: | Abstract Introduction Given an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research Network for Diabetes Registry: J-BRAND Registry) to elucidate the safety and efficacy profile of long-term usage of alogliptin. Research design and methods We registered 5969 patients from April 2012 through September 2014, who started receiving alogliptin (group A) or other classes of oral hypoglycemic agents (OHAs; group B), and were followed for 3 years at 239 sites nationwide. Safety was the primary outcome. Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs). Efficacy assessment was the secondary outcome and included changes in hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin and urinary albumin. Results Of the registered, 5150 (group A: 3395 and group B: 1755) and 5096 (3358 and 1738) were included for safety and efficacy analysis, respectively. Group A patients mostly (>90%) continued to use alogliptin. In group B, biguanides were the primary agents, while DPP-4 inhibitors were added in up to ~36% of patients. The overall incidence of AEs was similar between the two groups (42.7% vs 42.2%). Kaplan-Meier analysis revealed the incidence of cancer was significantly higher in group A than in group B (7.4% vs 4.8%, p=0.040), while no significant incidence difference was observed in the individual cancer. Multivariate Cox regression analysis revealed that the imbalanced patient distribution (more elderly patients in group A than in group B), but not alogliptin usage per se, contributed to cancer development. The incidence of other major AE categories was with no between-group difference. Between-group difference was not detected, either, in the incidence of microvascular and macrovascular complications. HbA1c and fasting glucose decreased significantly at the 0.5-year visit and nearly plateaued thereafter in both groups. Conclusions Alogliptin as a representative of DPP-4 inhibitors was safe and durably efficacious when used alone or with other OHAs for patients with type 2 diabetes in the real world setting. |
| Rights: | http://creativecommons.org/licenses/by-nc/4.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/80207 |
| Appears in Collections: | 医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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