Start of first outcome trials empagliflozin in chronic HF
Boehringer Ingelheim and Eli Lilly and Company announced that the EMPEROR HF (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) clinical trial programme has been initiated.
The EMPEROR HF programme consists of two event-driven phase III randomised, double-blind clinical trials that will investigate empagliflozin for the treatment of people with chronic heart failure with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF). Both trials, called EMPEROR HF-Preserved [NCT03057951] and EMPEROR HF-Reduced [NCT03057977], will assess the impact of treatment with empagliflozin once daily, on primary endpoints cardiovascular death and hospitalisation for heart failure up to 38 months as. The two trials will involve approximately 4 100 HFpEF and 2 800 HFrEF patients, including also non-diabetic patients, and are anticipated to complete in 2020.
Empagliflozin has been shown in the EMPA-REG OUTCOME trial to reduce the risk of cardiovascular death by 38 percent versus placebo in patients with type 2 diabetes and established heart disease, when added to standard of care. As one of the secondary endpoints, the trial also showed a reduction in the risk of hospitalisation for heart failure by 35 percent in this patient population.
Empagliflozin is an oral, once daily, highly selective sodium-glucose co-transporter-2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death reduction data in the label in several countries. Excretion of sugar, salt and water after the initiation of treatment with empagliflozin may contribute to the improvement in cardiovascular outcomes.