Heart failure & cardiomyopathiesSecondary analysis
Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure
- Prespecified secondary analysis of the SOLOIST-WHF randomised trial
- prespecified analyses
Authors' conclusion
Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics.
Study context
- Population
- Patients hospitalized or recently discharged after a worsening heart failure (HF) episode1,113 (91%) complete KCCQ-12 data
- Participants
- 1,222 patients
- Comparison
- Sotagliflozin vs placebo
- Primary endpoint
- Total number of HF hospitalizations, urgent HF visits and CV death (trial primary endpoint); this analysis: change in KCCQ-12 score from baseline to month 4 (prespecified secondary endpoint)
Primary result
Change in KCCQ-12 · 4 months
Adjusted mean change
4.1 points
95% CI 1.3–7.0
P = 0.005
Sotagliflozin vs Placebo
adjusted mean change 4.1 points (95% CI 1.3–7.0); P = 0.005
As reported in the abstract
Secondary outcomes
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| At least small (≥5 points) improvement in KCCQ-12 · 4 months | 1.38 (1.06–1.80) | P = 0.017 | |
| 0.512Odds ratio (log scale) |
Trial primary endpoint (total HF hospitalizations, urgent HF visits and CV death) by KCCQ-12 tertile
- Risk reduced consistently across KCCQ-12 tertiles
- P for trend = 0.54
KCCQ-12 change by prespecified subgroups (incl. LVEF <50% or ≥50%)
- Improvements consistent across prespecified subgroups
Baseline KCCQ-12 score (overall)
- Median 41.7 (Q1-Q3: 27.1-58.3); improved by 4 months in both groups
Original publication
Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure. J Am Coll Cardiol. Published 17 September 2024. doi:10.1016/j.jacc.2024.06.036
Summarised from the published abstract; every number is checked against it