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

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dc.contributor.author SOLOIST-WHF Comm Investigators
dc.contributor.author Szarek, Michael
dc.contributor.author Bhatt, Deepak L.
dc.contributor.author Steg, Ph Gabriel
dc.contributor.author Harjola, Veli-Pekka
dc.date.accessioned 2022-02-17T07:59:02Z
dc.date.available 2022-02-17T07:59:02Z
dc.date.issued 2021-08
dc.identifier.citation 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
dc.identifier.other PURE: 174225701
dc.identifier.other PURE UUID: 5e71b9e6-939a-4966-94c4-a4a2aa862bc5
dc.identifier.other WOS: 000695277800016
dc.identifier.uri http://hdl.handle.net/10138/340512
dc.description.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. en
dc.format.extent 15
dc.language.iso eng
dc.relation.ispartof Annals of Internal Medicine
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject INHIBITORS
dc.subject COVID-19
dc.subject EVENTS
dc.subject 3121 General medicine, internal medicine and other clinical medicine
dc.title Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure A Randomized Trial en
dc.type Article
dc.contributor.organization HUS Emergency Medicine and Services
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.7326/M21-0651
dc.relation.issn 0003-4819
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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