Efficacy and safety of efpeglenatide in key patient subgroups from the BALANCE randomized trial, stratified by pre-diabetes status, BMI, and age at baseline.
| Autor: | Pratley RE; Translational Research Institute, AdventHealth Central Florida, Orlando, Florida, USA Richard.Pratley.MD@AdventHealth.com., Jacob S; Cardio-Metabolic-Institute, Praxis für Prävention und Therapie, Villingen-Schwenningen, Germany., Baek S; Hanmi Pharmaceutical, Seoul, Republic of Korea., Trautmann ME; ProSciento, Chula Vista, California, USA., Hompesch M; ProSciento, Chula Vista, California, USA., Han O; Hanmi Pharmaceutical, Seoul, Republic of Korea., Stewart J; Sanofi Canada, Laval, Quebec, Canada., Sorli CH; Sanofi, Bridgewater, New Jersey, USA., Shaunik A; Sanofi, Bridgewater, New Jersey, USA., Yoon KH; Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. |
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| Jazyk: | angličtina |
| Zdroj: | BMJ open diabetes research & care [BMJ Open Diabetes Res Care] 2022 Jan; Vol. 10 (1). |
| DOI: | 10.1136/bmjdrc-2021-002207 |
| Abstrakt: | Introduction: Efpeglenatide is a long-acting glucagon-like peptide-1 receptor agonist being developed to improve glycemic control in type 2 diabetes (T2D). In the BALANCE 205 study (NCT02075281), efpeglenatide significantly reduced body weight versus placebo in patients with obesity, or overweight with comorbidities, and without T2D. These subanalyses explore the efficacy and safety of efpeglenatide in subgroups of patients with pre-diabetes and stratified by body mass index (BMI) or age from the BALANCE study. Research Design and Methods: The 20-week BALANCE study randomized patients with BMI ≥30 kg/m 2 or ≥27 kg/m 2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo. For these subanalyses, patients were stratified by pre-diabetes status (glycated hemoglobin (HbA Results: In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%-64.3%) versus placebo (10.0%), and greater reductions in HbA Conclusions: These results are consistent with the overall BALANCE population and suggest beneficial effects of efpeglenatide on glycemic control and body weight regardless of pre-diabetes status, age, or BMI at baseline. The effects of efpeglenatide on glycemic control in patients with pre-diabetes suggest it might help reduce the likelihood of at-risk patients developing diabetes. Competing Interests: Competing interests: REP has served as a consultant for AstraZeneca, Glytec, Janssen Pharmaceuticals, Merck, MundiPharma, Novo Nordisk, Pfizer, Sanofi, Sanofi US Services, Scohia Pharma, and Sun Pharmaceutical Industries; has received grants and research support from Hanmi Pharmaceutical, Janssen Pharmaceuticals, Metavention, Novo Nordisk, Poxel SA, and Sanofi; and has received honoraria from Novo Nordisk; honoraria and fees for these activities were directed to a non-profit organization with the exception of those from Sanofi US Services, which were personal fees. SB is an employee of Hanmi Pharmaceutical. MET is a consultant of ProSciento; has received consulting fees from Atrogi, CeQur SA, Hanmi Pharmaceutical, Kinexum, Novo Nordisk, and Servier; and is on the Data Monitoring Board for Profil. MH is an employee and shareholder of ProSciento and has received grants from Hanmi Pharmaceutical. OH is an employee of Hanmi Pharmaceutical. JS is an employee and shareholder of Sanofi. AS was an employee of Sanofi during the development of this publication. CHS was an employee and shareholder of Sanofi during the development of this publication. SJ has received personal fees from AstraZeneca, Boehringer Ingelheim, Lilly, MSD, Novo Nordisk, and Sanofi. K-HY has nothing to declare. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Databáze: | MEDLINE |
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