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Eligibility for sotagliflozin in a real-world heart failure population based on the SOLOIST-WHF trial enrolment criteria: data from the Swedish heart failure registry
Karolinska Inst, Sweden; Univ Med Ctr Hamburg Eppendorf, Germany; German Ctr Cardiovasc Res DZHK, Germany.
Karolinska Inst, Sweden; Karolinska Univ Hosp, Sweden.
Karolinska Inst, Sweden.
Linköping University, Department of Health, Medicine and Caring Sciences, Division of Diagnostics and Specialist Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart Center, Department of Cardiology in Linköping.ORCID iD: 0000-0001-6353-8041
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2023 (English)In: European Heart Journal - Cardiovascular Pharmacotherapy, ISSN 2055-6837, E-ISSN 2055-6845, Vol. 9, no 4, p. 343-352Article in journal (Refereed) Published
Abstract [en]

Aims The SOLOIST-WHF trial demonstrated efficacy of sotagliflozin in patients with type 2 diabetes mellitus (T2DM) and recent worsening heart failure (HF) regardless of ejection fraction (EF). Selection criteria in trials may limit their generalizability. Therefore, we aimed to investigate eligibility for sotagliflozin based on the SOLOIST-WHF criteria in a real-world HF population. Methods and results SOLOIST-WHF criteria were applied to patients stabilized after HF hospitalization in the Swedish HF Registry according to (i) literal scenario (all inclusion/exclusion criteria) or (ii) pragmatic scenario (only criteria likely to influence treatment decisions). Of 5453 inpatients with T2DM and recent worsening HF, 51.4% had reduced EF (HFrEF), 19.1% mildly reduced (HFmrEF), and 29.5% preserved EF (HFpEF). Eligibility (literal) was: 27.2% (32.4% in HFrEF, 24.7% in HFmrEF, 19.7% in HFpEF) and eligibility (pragmatic) was 62.8% (69.1%, 60.3%, 53.4%, respectively). In the literal scenario, criteria limiting eligibility were HF duration <3 months, eGFR <30 ml/min/1.73 m(2), age >85 years, acute coronary syndrome <3 months, and insufficiently high N-terminal pro-B-type natriuretic peptide levels. Eligible vs. non-eligible patients had more severe HF, higher cardiovascular (CV) comorbidity burden, higher use of HF treatments, and higher event rates (all-cause death 30.8 vs. 27.2 per 100 patient-years, CV death 19.1 vs. 16.6, and HF hospitalization 36.7 vs. 24.0). Conclusion In this large, real-world HF cohort with T2DM, similar to 1/3 of patients were eligible for sotagliflozin in the literal and similar to 2/3 of patients in the pragmatic scenario. Eligible patients had more severe HF and higher event rates, in particular CV and HF events.

Place, publisher, year, edition, pages
OXFORD UNIV PRESS , 2023. Vol. 9, no 4, p. 343-352
Keywords [en]
SOLOIST-WHF; Sotagliflozin; Heart failure; Worsening heart failure; Type 2 diabetes mellitus; Eligibility; SGLT1; 2 inhibitors; Randomized controlled trial (RCT)
National Category
Cardiology and Cardiovascular Disease
Identifiers
URN: urn:nbn:se:liu:diva-192525DOI: 10.1093/ehjcvp/pvad012ISI: 000934863700001PubMedID: 36718512OAI: oai:DiVA.org:liu-192525DiVA, id: diva2:1745264
Available from: 2023-03-22 Created: 2023-03-22 Last updated: 2025-02-10

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Dahlström, UlfKarlström, Patric
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Division of Diagnostics and Specialist MedicineFaculty of Medicine and Health SciencesDepartment of Cardiology in Linköping
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