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oai:repisalud.isciii.es:20.500.12105/160992025-06-19T15:30:30Zcom_20.500.12105_2052com_20.500.12105_2051com_20.500.12105_15322col_20.500.12105_19613col_20.500.12105_16927col_20.500.12105_16977

00925njm 22002777a 4500 dc Gabriel-Sanchez, Rafael author Boukichou-Abdelkader, Nisa author Gilis-Januszewska, Aleksandra author Makrilakis, Konstantinos author Gómez-Huelgas, Ricardo author Kamenov, Zdravko author Paulweber, Bernhard author Satman, Ilhan author Djordjevic, Predrag author Alkandari, Abdullah author Mitrakou, Asimina author Lalic, Nebojsa author Egido, Jesús author Más-Fontao, Sebastián author Calvet, Jean Henri author Pastor, José Carlos author Lindström, Jaana author Lind, Marcus author Acosta, Tania author Silva, Luis author Tuomilehto, Jaakko author E-Predice Consortium author 2023-03-03 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. J Clin Med. 2023 Mar 3;12(5):2035. 10.3390/jcm12052035 2077-0383 Journal of clinical medicine 36902821 http://hdl.handle.net/20.500.12105/16099 Antidiabetic drugs Glomerular filtration Lifestyle intervention Peripheral neuropathy risk Prediabetes 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