Efficacy of sotagliflozin among older adults: a pooled analysis of SCORED and SOLOIST-WHF

Background Sotagliflozin is a dual sodium-glucose cotransport 1 and 2 (SGLT-1 and SGLT-2) inhibitor with efficacy in improving cardiovascular (CV) endpoints in patients with chronic kidney disease (CKD) or heart failure (HF). It is unknown whether the efficacy of sotagliflozin varies with age, especially among older adults. Purpose In this pooled analysis of SCORED and SOLOIST-WHF, we evaluated the efficacy of sotagliflozin among older adults. Methods SCORED and SOLOIST-WHF were multicenter, double-blind trials randomizing patients to sotagliflozin compared with placebo. SCORED enrolled patients with type 2 diabetes (T2D) CKD, and high CV risk, while SOLOIST-WHF enrolled patients with T2D and recent heart failure (HF) hospitalization. In this pooled analysis, patients from SCORED and SOLOIST-WHF were evaluated by age, both categorically (≥65 years vs <65 years, a pre-specified subgroup in both SCORED and SOLOIST-WHF) and continuously. The primary endpoint was total CV death, hospitalization for HF, or urgent visit for HF. Additional endpoints included total major adverse cardiovascular events (MACE), consisting of CV death, myocardial infarction, and stroke. Results A total of 5900 (50.0%) and 5906 (50.0%) patients were in the sotagliflozin and placebo groups. Median age was 69 years (interquartile range: 63, 74 years), with 3588 (30.4%) and 8218 (69.6%) patients <65 vs ≥65 years respectively. Sotagliflozin compared with placebo reduced the rate of the primary endpoint overall (8.5 vs 11.8 events/100 person-years [p-y]; hazard ratio [HR]: 0.72 [95% CI: 0.63, 082]) and among adults <65 years (7.6 vs 10.2 events/100 p-y; HR: 0.68 [95% CI: 0.52, 0.90]) and ≥65 years (8.9 vs 12.4 events/100 p-y; HR: 0.73 [95% CI: 0.63, 0.86])(Pinteraction[int]=0.67) (Table). Sotagliflozin similarly reduced total MACE (5.7 vs 7.1 events/100 p-y; HR: 0.80 [95% CI: 0.69, 0.93]), with consistent findings among adults <65 years (5.1 vs 6.2 events/100 p-y; HR: 0.79 [95% CI: 0.59, 1.05]) and ≥65 years (5.9 events/100 p-y vs 7.4 events/100 p-y; HR: 0.80 [95% CI: 0.67, 0.96]) ])(Pint=0.91). Sotagliflozin led to similar and consistent benefit across the spectrum of age for both the primary endpoint (Pint=0.72) and MACE (Pint=0.85) (Figure). Conclusions Among patients with type 2 diabetes and either CKD or HF, sotagliflozin improved HF endpoints and MACE irrespective of age, including among older adults.