Abstract 11884: Comparison of Investigator-Reported and Adjudicated Events From SOLOIST-WHF and SCORED

Abstract

Introduction: Sotagliflozin reduced investigator reported cardiovascular (CV) deaths, hospitalizations for heart failure (HHF), and urgent visits for heart failure (UVHF) in SOLOIST-WHF and SCORED. The objective of the present analysis was to determine if the treatment effects on adjudicated events were consistent those on investigator reported events in each trial. Methods: SOLOIST-WHF and SCORED were Phase 3, multicenter, randomized, double-blind, trials evaluating sotagliflozin versus placebo in 1,222 patients with type 2 diabetes (T2D) admitted for a worsening heart failure event and in 10,584 patients with T2D, chronic kidney disease, and other CV risk factors, respectively. The primary composite endpoint was a composite of CV death, HHF, and UVHF. Treatment effects on investigator reported events and available adjudicated events were estimated in proportional hazards models. Results: Rates of the investigator reported primary composite endpoint were higher in the SOLOIST-WHF trial compared with the SCORED trial. However, relative risk reductions for the investigator reported primary composite endpoint were similar between SCORED (0.67[0.53, 0.85]) and SOLOIST-WHF (0.75[0.63, 0.88]). All components of the endpoint positively contributed to the overall outcome, with HHF having the largest effect. When compared with adjudicated outcomes, results were generally similar between the primary and sensitivity analyses using various combinations of total or first occurrences (Figure). Conclusions: Sotagliflozin led to consistent and significant reductions in CV death, HHF, and UVHF in both randomized trials, as determined by blinded investigator-reported assessment as well as by independent, blinded adjudication. These results support the overall robustness of the findings for both trials.