Introduction and methods

Benefits Of Sodium Glucose Co-transporter-1/2 Inhibition With Sotagliflozin Across The Full Spectrum Of Ejection Fraction, Including Heart Failure With Preserved Ejection Fraction

Presented at ACC.21 by Prof. Deepak Bhatt, MD (Boston, MA, USA)

The SOLOIST and SCORED trials showed that the dual SGLT1 and SGLT2 inhibitor sotagliflozin reduced HF hospitalizations in patients with HFrEF. The current analysis pooled patient-level data from both trials and determined the effect of sotagliflozin in patients with HFpEF.

The SOLOIST trial included 1222 patients with diabetes and worsening HF and SCORED included 10584 patients with diabetes and CKD. In both trials, patients were randomly assigned to treatment with either sotagliflozin or placebo. Median follow up of SOLOIST was 9 months, and median follow up of SCORED was 16 months. The primary endpoint of both trials was total number of CV deaths, HF hospitalizations, and urgent visits for HF. The current pooled patient-level analysis determined the effect of sotagliflozin on the primary endpoint as a function of baseline ejection fraction (EF).

Main results

• The pooled analysis showed a statistically significant and consistent benefit of sotagliflozin for the primary endpoint of CV deaths, HF hospitalizations, and urgent visits for HF across the full range of baseline EF (EF<40% [n=1758]: HR 0.78, 95%CI 0.63-0.96, P=0.02; EF 40-50% [n=811]: HR 0.57, 95%CI 0.40-0.82, P=0.002; EF≥50% [n=1931]: HR 0.67, 95%CI 0.51-0.89, p=0.006; P for interaction by EF category=0.35). These benefits were present in both of the trials.
• In on-treatment analysis, sotagliflozin demonstrated a significant reduction in CV death (HR 0.73, 95%CI 0.55-0.98).
• The benefit of sotagliflozin is consistent in both males and females. Sotagliflozin significantly reduced the primary endpoint in women with an EF≥50% (n=1052, HR 0.65, 95%CI 0.46-0.92).

Conclusion

This pooled patient-level analysis using data from SOLOIST and SCORED showed that the dual SGLT1/2 inhibitor sotagliflozin significantly reduced the primary endpoint of total CV deaths, hospitalizations for HF, and urgent visits for HF across the full range of baseline EF.

Discussion

The discussant Ileana Piña, MD (Mount Pleasant, MI, USA) said that the fact that these results were positive in women is very encouraging as the HFpEF population is often comprised of older women. She also mentioned that there are prospective trials ongoing that directly and prospectively investigate the effects of these drugs in HFpEF. The results from these trials are expected before the end of this year.

-Our coverage of ACC.21 is based on the information provided during the congress –