A Randomized Clinical Trial of Linagliptin vs. Standard of Care in Patients Hospitalized With Diabetes and COVID-19.

Autor:	Abuhasira R; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine B, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel., Ayalon-Dangur I; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine E, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel., Zaslavsky N; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine B, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel., Koren R; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine A, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel., Keller M; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine A, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel., Dicker D; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine D, Rabin Medical Center, Hasharon Campus, Petah Tikva, Israel., Grossman A; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Department of Internal Medicine B, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.
Jazyk:	angličtina
Zdroj:	Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2021 Dec 22; Vol. 12, pp. 794382. Date of Electronic Publication: 2021 Dec 22 (Print Publication: 2021).
DOI:	10.3389/fendo.2021.794382
Abstrakt:	Objective: To assess the effect of linagliptin vs. standard therapy in improving clinical outcomes in patients hospitalized with diabetes and coronavirus disease 2019 (COVID-19). Materials and Methods: We did an open-label, prospective, multicenter, randomized clinical trial in 3 Israeli hospitals between October 1, 2020, and April 4, 2021. Eligible patients were adults with type 2 diabetes mellitus and a diagnosis of COVID-19. A total of 64 patients, 32 in each group, were randomized to receive linagliptin 5 mg PO daily throughout the hospitalization or standard of care therapy. The primary outcome was time to clinical improvement within 28 days after randomization, defined as a 2-point reduction on an ordinal scale ranging from 0 (discharged without disease) to 8 (death). Results: The mean age was 67 ± 14 years, and most patients were male (59.4%). Median time to clinical improvement was 7 days (interquartile range (IQR) 3.5-15) in the linagliptin group compared with 8 days (IQR 3.5-28) in the standard of care group (hazard ratio, 1.22; 95% CI, 0.70-2.15; p = 0.49). In-hospital mortality was 5 (15.6%) and 8 (25.0%) in the linagliptin and standard of care groups, respectively (odds ratio, 0.56; 95% CI, 0.16-1.93). The trial was prematurely terminated due to the control of the COVID-19 outbreak in Israel. Conclusions: In this randomized clinical trial of hospitalized adult patients with diabetes and COVID-19 who received linagliptin, there was no difference in the time to clinical improvement compared with the standard of care. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT04371978. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Abuhasira, Ayalon-Dangur, Zaslavsky, Koren, Keller, Dicker and Grossman.)
Databáze:	MEDLINE
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