No improvement in exercise ability with SGLT2i in two HF trials, one in HFrEF and one in HFpEF patients
It was announced that there was no significant change in exercise ability, measured by six-minute walk test, after 12 weeks with use of the SGLT2 inhibitor empagliflozin vs. placebo in the EMPERIAL-Reduced trial enrolling HF patients with reduced ejection fraction (HFrEF) and in the EMPERIAL-Preserved trial enrolling HF patients with preserved ejection fraction (HFpEF). There were no new safety risks identified in the EMPERIAL trials.
The ongoing program also includes the EMPEROR-Preserved, EMPEROR-Reduced, EMPULSE and EMPA-VISION studies. The program examines the effects of empagliflozin on HF-related outcomes and patient-related outcomes in HF patients. The EMPERIAL trials were started after positive results from the EMPA-REG OUTCOME trial, which demonstrated a 38% relative risk reduction in CV death and a 35% relative risk reduction in HF hospitalization with empagliflozin compared to placebo in type 2 diabetes patients with established CVD. Full results from the EMPERIAL trials will be reported later in 2020.
EMPERIAL-preserved (315 patients) and EMERPIAL-reduced (312 patients) are two phase III randomized, double-blind trials in HF patients with or without diabetes. The trials examined the effect of empagliflozin compared to placebo on exercise ability and HF symptoms after 12 weeks in HFpEF and HFrEF patients. The primary endpoint was measured by the six-minute walk test.