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Sotagliflozin and Health Status in Worsening HF
Quick Takes
- Treatment with the dual SGLT1 and SGLT2 inhibitor sotagliflozin after a worsening HF episode improved HF-related symptoms, physical limitations, and quality of life within 4 months of treatment initiation.
- Furthermore, benefits were consistent across baseline health status, ejection fraction, demographic characteristics, and clinical characteristics.
Study Questions:
What are the effects of sotagliflozin versus placebo on heart failure (HF)-related health status?
Methods:
The investigators evaluated change in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline to month 4 in the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial. SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. KCCQ-12 score was a prespecified secondary endpoint. An analysis of covariance was used, with treatment group as a factor and adjusted for baseline KCCQ-12 score, baseline left ventricular ejection fraction (LVEF), and geographic region.
Results:
Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. The baseline KCCQ-12 score was low overall (median, 41.7; Q1-Q3, 27.1-58.3) and improved by 4 months in both groups. Sotagliflozin versus placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (p for trend = 0.54). Sotagliflozin treated patients versus those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change, 4.1 points; 95% confidence interval, 1.3-7.0 points; p = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including LVEF <50% or ≥50%. More patients receiving sotagliflozin versus those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (odds ratio, 1.38; 95% confidence interval, 1.06-1.80; p = 0.017).
Conclusions:
The authors report that sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF.
Perspective:
This study reports that treatment with the dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor sotagliflozin after a worsening HF episode improved HF-related symptoms, physical limitations, and quality of life within 4 months of treatment initiation. Furthermore, benefits were consistent across baseline health status, EF, demographic characteristics, and clinical characteristics. These data also highlight the importance of therapeutic development aimed at durably improving symptoms, physical functions, and quality of life in addition to clinical events.
Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure
Keywords: Health Status, Heart Failure, Sodium-Glucose Transporter 2 Inhibitors
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