Reduction in the Risk of Peripheral Neuropathy and Lower Decrease in Kidney Function with Metformin, Linagliptin or Their Fixed-Dose Combination Compared to Placebo in Prediabetes: A Randomized Controlled Trial.

Autor: Gabriel R; Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, 28029 Madrid, Spain.; World Community for Prevention of Diabetes Foundation (WCPD), 28001 Madrid, Spain.; Asociación para la Investigación y Prevención de la Diabetes y Enfermedades Cardiovasculares (PREDICOR), 28001 Madrid, Spain., Boukichou-Abdelkader N; Asociación para la Investigación y Prevención de la Diabetes y Enfermedades Cardiovasculares (PREDICOR), 28001 Madrid, Spain.; EVIDEM CONSULTORES, 28030 Madrid, Spain., Gilis-Januszewska A; Department of Endocrinology, Jagiellonian University Medical College, 31-008 Krakow, Poland., Makrilakis K; Medical School, National and Kapodistrian University of Athens, 11527 Athens, Greece., Gómez-Huelgas R; Internal Medicine Department, Regional University Hospital of Málaga, Biomedical Research Institute of Málaga (IBIMA), University of Málaga (UMA), 29018 Málaga, Spain., Kamenov Z; Clinic of Endocrinology, University Multi-Profile Hospital for Active Treatment Alexandrovska EAD, Medical University of Sofia, 1431 Sofia, Bulgaria., Paulweber B; Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft (SALK), 5020 Salzburg, Austria., Satman I; Division of Endocrinology & Metabolism, Department of Internal Medicine, Istanbul University, 34093 Istanbul, Turkey., Djordjevic P; General Hospital Medical System Beograd-MSB, 11010 Belgrade, Serbia., Alkandari A; Dasman Diabetes Research Institute, Kuwait City 15462, Kuwait., Mitrakou A; Alexandra Hospital, University of Athens, 11635 Athens, Greece., Lalic N; Faculty of Medicine, University of Belgrade, 11000 Belgrade, Serbia., Egido J; Renal, Vascular and Diabetes Research Laboratory, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain., Más-Fontao S; Renal, Vascular and Diabetes Research Laboratory, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Universidad Autónoma, 28040 Madrid, Spain., Calvet JH; IMPETO Medical, 92130 Paris, France., Pastor JC; Instituto Universitario de Oftalmobiología Aplicada (IOBA), Hospital Clínico Universitario, Universidad de Valladolid, 47011 Valladolid, Spain., Lindström J; Department of Public Health and Welfare, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland., Lind M; Department of Molecular and Clinical Medicine, University of Gothenburg, 413 45 Gothenburg, Sweden.; Department of Medicine, NU-Hospital Group, 451 53 Uddevalla, Sweden.; Department of Internal Medicine, Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden., Acosta T; Department of Public Health, Universidad del Norte, Barranquilla 080001, Colombia., Silva L; EVIDEM CONSULTORES, 28030 Madrid, Spain., Tuomilehto J; Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, 28029 Madrid, Spain.; World Community for Prevention of Diabetes Foundation (WCPD), 28001 Madrid, Spain.; Asociación para la Investigación y Prevención de la Diabetes y Enfermedades Cardiovasculares (PREDICOR), 28001 Madrid, Spain.; Department of Public Health and Welfare, Finnish Institute for Health and Welfare, 00271 Helsinki, Finland.; Department of Public Health, University of Helsinki, 00014 Helsinki, Finland.; Diabetes Research Group, King Abdulaziz University, Jeddah 21589, Saudi Arabia., On Behalf Of The E-Predice Consortium
Jazyk: angličtina
Zdroj: Journal of clinical medicine [J Clin Med] 2023 Mar 03; Vol. 12 (5). Date of Electronic Publication: 2023 Mar 03.
DOI: 10.3390/jcm12052035
Abstrakt: Objective: To compare the effect of glucose-lowering drugs on peripheral nerve and kidney function in prediabetes.
Methods: Multicenter, randomized, placebo-controlled trial in 658 adults with prediabetes treated for 1 year with metformin, linagliptin, their combination or placebo. Endpoints are small fiber peripheral neuropathy (SFPN) risk estimated by foot electrochemical skin conductance (FESC < 70 μSiemens) and estimated glomerular filtration rate (eGFR).
Results: Compared to the placebo, the proportion of SFPN was reduced by 25.1% (95% CI:16.3-33.9) with metformin alone, by 17.3% (95% CI 7.4-27.2) with linagliptin alone, and by 19.5% (95% CI 10.1-29.0) with the combination linagliptin/metformin ( p < 0.0001 for all comparisons). eGFR remained +3.3 mL/min (95% CI: 0.38-6.22) higher with the combination linagliptin/metformin than with the placebo ( p = 0.03). Fasting plasma glucose (FPG) decreased more with metformin monotherapy -0.3 mmol/L (95%CI: -0.48; 0.12, p = 0.0009) and with the combination metformin/linagliptin -0.2 mmol/L (95% CI: -0.37; -0.03) than with the placebo ( p = 0.0219). Body weight (BW) decreased by -2.0 kg (95% CI: -5.65; -1.65, p = 0.0006) with metformin monotherapy, and by -1.9 kg (95% CI: -3.02; -0.97) with the combination metformin/linagliptin as compared to the placebo ( p = 0.0002).
Conclusions: in people with prediabetes, a 1 year treatment with metformin and linagliptin, combined or in monotherapy, was associated with a lower risk of SFPN, and with a lower decrease in eGFR, than treatment with placebo.
Databáze: MEDLINE
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