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

To compare the effect of glucose-lowering drugs on peripheral nerve and kidney function in prediabetes. 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...

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Veröffentlicht in:Journal of clinical medicine 2023-03, Vol.12 (5), p.2035
Hauptverfasser: Gabriel, Rafael, Boukichou-Abdelkader, Nisa, Gilis-Januszewska, Aleksandra, Makrilakis, Konstantinos, Gómez-Huelgas, Ricardo, Kamenov, Zdravko, Paulweber, Bernhard, Satman, Ilhan, Djordjevic, Predrag, Alkandari, Abdullah, Mitrakou, Asimina, Lalic, Nebojsa, Egido, Jesús, Más-Fontao, Sebastián, Calvet, Jean Henri, Pastor, José Carlos, Lindström, Jaana, Lind, Marcus, Acosta, Tania, Silva, Luis, Tuomilehto, Jaakko, On Behalf Of The E-Predice Consortium
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Sprache:eng
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Zusammenfassung:To compare the effect of glucose-lowering drugs on peripheral nerve and kidney function in prediabetes. 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). 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 ( < 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 ( = 0.03). Fasting plasma glucose (FPG) decreased more with metformin monotherapy -0.3 mmol/L (95%CI: -0.48; 0.12, = 0.0009) and with the combination metformin/linagliptin -0.2 mmol/L (95% CI: -0.37; -0.03) than with the placebo ( = 0.0219). Body weight (BW) decreased by -2.0 kg (95% CI: -5.65; -1.65, = 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 ( = 0.0002). 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.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm12052035