2024年 新着論文 9 糖尿病診療分野から論文が発表されました
Safety and glycemic control with insulin degludec use in clinical practice: results from a 3-year Japanese post-marketing surveillance study
- PMID: 38264229
- PMCID: PMC10800319 (available on )
- DOI: 10.1007/s13340-023-00657-7
Abstract
Introduction: Insulin degludec (degludec) is a basal insulin with a long duration of action. This post-marketing surveillance study monitored safety and glycemic control during use of degludec for 3 years in normal clinical practice in Japan.
Materials and methods: This multicenter, open-label, observational study included patients with diabetes receiving degludec in Japan between 2013 and 2019. The primary outcome was incidence of adverse events occurring over 3 years of treatment. The pre-specified, secondary outcomes were severe hypoglycemic episodes and changes in HbA1c and fasting plasma glucose levels.
Results: Of 4167 patients enrolled, 4022 were included in the safety assessments and 3918 in the assessments of glycemic control. Mean age was 58.9 years; 74.1% of patients had type 2 diabetes, and mean HbA1c at baseline was 8.7%. Adverse events and serious adverse events were observed in 19.1% and 8.9% of patients, respectively. Cardiac disorders and neoplasms were reported in 2.0% and 1.8% of patients, respectively, with the majority of these incidents reported as serious adverse events. Adverse drug reactions were seen in 8.0% of patients, mainly hypoglycemia. Hypoglycemic events were observed in 5.6% of patients, and severe hypoglycemic events in 1.7%. No serious allergic or injection-site reactions were seen. Respective changes (from baseline to 3 years’ observation) in HbA1c and fasting plasma glucose levels were – 0.55% and – 36.3 mg/dL, and 19.6% of patients reached HbA1c < 7.0%.
Conclusions: Using degludec for 3 years in normal clinical practice had a good safety and tolerability profile. Improvements in glycemic control were also seen.
Supplementary information: The online version contains supplementary material available at 10.1007/s13340-023-00657-7.
Keywords: Basal insulin; Diabetes mellitus; Insulin; Observational study; Safety.
© The Japan Diabetes Society 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
Conflict of interest statement
Conflict of interestTakashi Murata has received honoraria from Eli Lilly Japan, Sanofi, Kowa Pharmaceutical, Novo Nordisk, Kyowa Kirin, and Takeda Pharmaceutical; and grants from Sanofi and Kowa Pharmaceutical. Lise Lotte N. Husemoen and Satoko Nemoto are employed by Novo Nordisk. Munehide Matsuhisa has received honoraria from Sanofi, Takeda Pharmaceutical, Eli Lilly Japan, Mitsubishi Tanabe Pharma Corporation, Astellas Pharma, Novo Nordisk, Orizuru Therapeutics, Sumitomo Pharma, Abbott Japan, and MSD; research funding from Sysmex, Nissui, and Tokushima Data Service; and subsidies or donations from Astellas Pharma, Nippon Boehringer Ingelheim, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Novartis, Sanofi, Novo Nordisk, Takeda Pharmaceutical, MSD, and Ono Pharmaceutical.
