Applying REWIND cardiovascular disease criteria to SUSTAIN 6 and PIONEER 6: An exploratory analysis of cardiovascular outcomes with semaglutide.

In the REWIND trial, dulaglutide reduced cardiovascular (CV) risk versus placebo in patients with type 2 diabetes (T2D) in both the 'established CV disease' (CVD) and 'CV risk factor' subgroups. The SUSTAIN 6 and PIONEER 6 trials of semaglutide used different criteria for established CVD than REWIND. This post hoc analysis assessed the effect of semaglutide on major adverse cardiovascular events (MACE) in a pooled population of SUSTAIN 6 and PIONEER 6 patients, re-categorized into CV risk subgroups using the REWIND CVD criteria. In the pooled analysis (n = 6480), a lower percentage of patients were in the established CVD subgroup, when using the REWIND CVD criteria, compared with the original trial CVD criteria (66.5% versus 83.8%, respectively). After re-categorization, the risk of MACE was significantly lower with semaglutide versus placebo in the established CVD subgroup (hazard ratio [HR], 95% confidence interval [CI]: 0.74 [0.59, 0.92]) and non-significantly lower in the CV risk factor subgroup (HR, 95% CI: 0.84 [0.55, 1.28]) (P-interaction=0.60). These results suggest that the CV effects of semaglutide may extend to patients with T2D across the CV risk continuum. This article is protected by copyright. All rights reserved.