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

Abstract 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...

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Bibliographic Details
Published in:European heart journal. Cardiovascular pharmacotherapy 2023-06, Vol.9 (4), p.343-352
Main Authors: Becher, Peter Moritz, Savarese, Gianluigi, Benson, Lina, Dahlström, Ulf, Karlström, Patric, Mol, Peter G M, Metra, Marco, Bhatt, Deepak L, Pitt, Bertram, Lund, Lars H
Format: Article
Language:English
Subjects:
Aged, 80 and over
Cardiology
Clinical trials
Coronary heart disease
Dapagliflozin
Diabetes
Diabetes Mellitus, Type 2 - diagnosis
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - epidemiology
Drug therapy
Heart failure
Heart Failure - diagnosis
Heart Failure - drug therapy
Heart Failure - epidemiology
Humans
Medical equipment and supplies industry
Medical test kit industry
Medicin och hälsovetenskap
Natriuretic peptides
Patients
Pharmaceutical industry
Public health
Registries
Stroke Volume
Sweden - epidemiology
Type 2 diabetes
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Summary:Abstract 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
ISSN:2055-6837
2055-6845
2055-6845
DOI:10.1093/ehjcvp/pvad012