Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure A Randomized Trial

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SOLOIST-WHF Comm Investigators , Szarek , M , Bhatt , D L , Steg , P G & Harjola , V-P 2021 , ' Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure A Randomized Trial ' , Annals of Internal Medicine , vol. 174 , no. 8 , pp. 1065-+ . https://doi.org/10.7326/M21-0651

Title: Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure A Randomized Trial
Author: SOLOIST-WHF Comm Investigators; Szarek, Michael; Bhatt, Deepak L.; Steg, Ph Gabriel; Harjola, Veli-Pekka
Contributor organization: HUS Emergency Medicine and Services
Date: 2021-08
Language: eng
Number of pages: 15
Belongs to series: Annals of Internal Medicine
ISSN: 0003-4819
DOI: https://doi.org/10.7326/M21-0651
URI: http://hdl.handle.net/10138/340512
Abstract: Background: In the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial, sotagliflozin, a sodium-glucose cotransporter-1 and sodium-glucose cotransporter-2 inhibitor, reduced total occurrences of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure relative to placebo by 33%. Objective: To determine whether sotagliflozin increased the prespecified efficacy outcome of days alive and out of the hospital (DAOH) in the SOLOIST-WHF trial. Design: Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT03521934) Setting: 306 sites in 32 countries. Participants: 1222 patients with type 2 diabetes and reduced or preserved ejection fraction who were recently hospitalized for worsening heart failure. Intervention: 200 mg of sotagliflozin once daily (with a possible dose increase to 400 mg) or matching placebo. Measurements: The primary analysis included hospitalizations for any reason on the basis of investigator-reported incidence and duration of admissions after randomization. Days alive and out of the hospital and its converse (days dead and days in the hospital) were analyzed using prespecified Poisson regression models. Results: Although similar proportions of patients in the sotagliflozin and placebo groups were hospitalized at least once (38.5% vs. 41.4%), fewer patients in the sotagliflozin group were hospitalized more than once (16.3% vs. 22.1%). There were 64 and 76 deaths in the sotagliflozin and placebo groups, respectively. The DAOH rate in the sotagliflozin group was 3% higher than in the placebo group (rate ratio [RR], 1.03 [95% CI, 1.00 to 1.06]; P = 0.027). This difference was primarily driven by a reduction in the rate of days dead (RR, 0.71 [CI, 0.52 to 0.99]; P = 0.041) rather than by a reduction in the rate of days hospitalized for any cause. For every 100 days of follow-up, patients in the sotagliflozin group were alive and out of the hospital for 3% or 2.9 more days than those in the placebo group (91.8 vs. 88.9 days); this difference reflected a 2.6-day difference in days dead (6.3 vs. 8.9 days) and a 0.3-day difference in days in the hospital (1.9 vs. 2.2 days). Limitation: Other than heart failure, the primary reason for each hospitalization was unspecified. Conclusion: Sotagliflozin increased DAOH, a metric that may provide an additional patient-centered outcome to capture the totality of disease burden. Future studies are needed to quantify the consequences of increasing DAOH in terms of health economics and patient quality of life.
Subject: INHIBITORS
COVID-19
EVENTS
3121 General medicine, internal medicine and other clinical medicine
Peer reviewed: Yes
Usage restriction: openAccess
Self-archived version: publishedVersion


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