Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Summary

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: * The total occurrences of HHF and urgent visit for HF * The occurrence of CV death * The occurrence of all-cause mortality * The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke * Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score * Change in estimated glomerular filtration rate (eGFR)

Timeline

Start

2018-06-15

Primary completion

2020-06-05

Completion

2020-06-05

Publications

• Bhatt AS, Bhatt DL, Steg PG, Szarek M, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Testani JM, Wilcox CS, Davies M, Pitt B, Kosiborod MN. Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure: Results From SOLOIST-WHF. J Am Coll Cardiol. 2024 Sep 17;84(12):1078-1088. doi: 10.1016/j.jacc.2024.06.036.
• Weintraub WS, Kolm P, Dolman S, Alva M, Bhatt DL, Zhang Z. Cost-Effectiveness of Sotagliflozin in SOLOIST-WHF. JACC Heart Fail. 2024 Sep;12(9):1600-1610. doi: 10.1016/j.jchf.2024.04.018. Epub 2024 Jun 12.
• Kim J, Wang S, Sikirica S, Shafrin J. Cost-effectiveness of sotagliflozin for the treatment of patients with diabetes and recent worsening heart failure. J Comp Eff Res. 2024 Jun;13(6):e230190. doi: 10.57264/cer-2023-0190. Epub 2024 May 21.
• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
• Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.
• Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.

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