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
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
|---|---|
| Enthalten in: |
Journal of clinical medicine - 12(2023), 5 vom: 03. März |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Gabriel, Rafael [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antidiabetic drugs |
|---|
| Anmerkungen: |
Date Revised 14.03.2023 published: Electronic Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.3390/jcm12052035 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM354084569 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM354084569 | ||
| 003 | DE-627 | ||
| 005 | 20231226061447.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3390/jcm12052035 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1180.xml |
| 035 | |a (DE-627)NLM354084569 | ||
| 035 | |a (NLM)36902821 | ||
| 035 | |a (PII)2035 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Gabriel, Rafael |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a 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 |b A Randomized Controlled Trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 14.03.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a OBJECTIVE: To compare the effect of glucose-lowering drugs on peripheral nerve and kidney function in prediabetes | ||
| 520 | |a 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) | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a antidiabetic drugs | |
| 650 | 4 | |a glomerular filtration | |
| 650 | 4 | |a lifestyle intervention | |
| 650 | 4 | |a peripheral neuropathy risk | |
| 650 | 4 | |a prediabetes | |
| 700 | 1 | |a Boukichou-Abdelkader, Nisa |e verfasserin |4 aut | |
| 700 | 1 | |a Gilis-Januszewska, Aleksandra |e verfasserin |4 aut | |
| 700 | 1 | |a Makrilakis, Konstantinos |e verfasserin |4 aut | |
| 700 | 1 | |a Gómez-Huelgas, Ricardo |e verfasserin |4 aut | |
| 700 | 1 | |a Kamenov, Zdravko |e verfasserin |4 aut | |
| 700 | 1 | |a Paulweber, Bernhard |e verfasserin |4 aut | |
| 700 | 1 | |a Satman, Ilhan |e verfasserin |4 aut | |
| 700 | 1 | |a Djordjevic, Predrag |e verfasserin |4 aut | |
| 700 | 1 | |a Alkandari, Abdullah |e verfasserin |4 aut | |
| 700 | 1 | |a Mitrakou, Asimina |e verfasserin |4 aut | |
| 700 | 1 | |a Lalic, Nebojsa |e verfasserin |4 aut | |
| 700 | 1 | |a Egido, Jesús |e verfasserin |4 aut | |
| 700 | 1 | |a Más-Fontao, Sebastián |e verfasserin |4 aut | |
| 700 | 1 | |a Calvet, Jean Henri |e verfasserin |4 aut | |
| 700 | 1 | |a Pastor, José Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Lindström, Jaana |e verfasserin |4 aut | |
| 700 | 1 | |a Lind, Marcus |e verfasserin |4 aut | |
| 700 | 1 | |a Acosta, Tania |e verfasserin |4 aut | |
| 700 | 1 | |a Silva, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Tuomilehto, Jaakko |e verfasserin |4 aut | |
| 700 | 1 | |a On Behalf Of The E-Predice Consortium |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of clinical medicine |d 2012 |g 12(2023), 5 vom: 03. März |w (DE-627)NLM230666310 |x 2077-0383 |7 nnns |
| 773 | 1 | 8 | |g volume:12 |g year:2023 |g number:5 |g day:03 |g month:03 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3390/jcm12052035 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 12 |j 2023 |e 5 |b 03 |c 03 | ||