Treatment intensification following glucagon-like peptide-1 receptor agonist in type 2 diabetes: Comparative effectiveness analyses between free vs. fixed combination of GLP-1 RA and basal insulin. RESTORE-G real-world study.

Autor: Candido R; Diabetes Centre District 3, Azienda Sanitaria Universitaria Integrata, Trieste, Italy., Nicolucci A; CORESEARCH, Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy. Electronic address: nicolucci@coresearch.it., Larosa M; Medical Affairs, Sanofi S.r.l., Milan, Italy., Rossi MC; CORESEARCH, Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy., Napoli R; Department of Translational Medical Sciences, Unit of Internal Medicine and Diabetes, Federico II University School of Medicine and Institute of Experimental Endocrinology and Oncology, National Research Council, Napoli, Italy; AOU Federico II, Napoli, Italy.
Jazyk: angličtina
Zdroj: Nutrition, metabolism, and cardiovascular diseases : NMCD [Nutr Metab Cardiovasc Dis] 2024 Aug; Vol. 34 (8), pp. 1846-1853. Date of Electronic Publication: 2024 Mar 23.
DOI: 10.1016/j.numecd.2024.03.023
Abstrakt: Background and Aims: Add-on of basal insulin (BI) to intensify the ongoing therapy with glucagon-like peptide 1 receptor agonist (GLP-1 RA) is recommended, but it is unclear if free or fixed combination of BI and GLP-1 RA produce similar outcomes. A retrospective comparative effectiveness analysis of the add-on of glargine 300 U/mL (Gla-300) to ongoing GLP-1 RA vs. switch to fixed ratio combination of degludec and liraglutide (iDegLira) was performed.
Methods and Results: Real-world data collected in electronic medical records by 32 Italian diabetes clinics. Propensity score (PS) adjustment was applied to assess changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), body weight, and BI dose after 6 months from Gla-300 or iDegLira initiation. Compared to iDegLira group (N = 260), Gla-300+GLP-1 RA group (N = 255) had older age and higher levels of HbA1c (9.1 vs. 8.9%). After 6 months, statistically significant greater FBG improvement [estimated mean difference and 95% confidence intervals: -24.05 mg/dl (-37.04; -11.06; p = 0.0003) and BI dose increase [+0.03 U/kg (95%CI 0.00; 0.06); p = 0.009] were found in the free vs. fixed combination group, although low doses of BI (0.2 U/kg) were reached in both groups. Trends of larger HbA1c and body weight reductions with the free combination were also found, without reaching the statistical significance.
Conclusion: Although inertia in insulin initiation and titration was documented in both groups, higher benefit on FBG control was obtained with free vs. fixed combination, likely due to a better titration of BI and GLP-1 RA.
Competing Interests: Declaration of competing interest Riccardo Candido has received consultancy fees from Boehringer Ingelheim, Eli-Lilly, Novo Nordisk, Astra-Zeneca, Sanofi-Aventis, Roche Diabetes Care; speaking fees from Astra Zeneca, Boehringer Ingelheim, Eli-Lilly, Novo Nordisk, Sanofi-Aventis, Mundipharma Pharmaceutical, Abbott, MSD, Neopharmed Gentili, Menarini, Essex Italia, Ascensia Diabetes. Antonio Nicolucci and Maria Chiara Rossi have received funding for research from Sanofi, NovoNordisk, Alfasigma, Artsana, AstraZeneca, Johnson&Johnson, Medtronic, Shionogi, SOBI, Meteda and Theras. Monica Larosa is an employee of Sanofi and may hold shares and/or stock options in the company. Raffaele Napoli has served on advisory board panels, received consultancy and speaker's fees or financial support for research from AstraZeneca, Boerhinger Ingelheim, Eli Lilly, Novo Nordisk, MSD, Sanofi.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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