The studies will be done in patients with and without type 2 diabetes.
Two phase 3 clinical trials have started to study empagliflozin (Jardiance) for the treatment of adults with chronic heart failure; the trials will study both adults with type 2 diabetes (T2D) and those without diabetes.
Empagliflozin was the third in a class of drugs called sodium glucose co-transporter-2 (SGLT2) inhibitors approved in the United States to treat T2D. The drugs work through a unique mechanism of action that expels excess blood glucose through the urine. The SGLT2 inhibitor class has been shown to have several other benefits, such as reducing blood pressure and helping patients lose weight.
In September 2015, empagliflozin was the first in the SGLT2 inhibitor class to demonstrate a cardioprotective benefit, when the EMPA-REG OUTCOME trial demonstrated a 38% reduction in the risk of cardiovascular death for patients with T2D and high CV risk. The drug also reduced the risk of hospitalization for heart failure by 35%. These results led to the new trials, known as EMPORER HF.
Results for cardiovascular outcomes trials for market competitors canagliflozin and dapagliflozin are not complete.
Heart failure is a condition in which the heart fails to properly pump blood throughout the body. The trials will be event-driven and measure the impact of treatment with empagliflozin on cardiovascular death and hospitalization for heart failure are primary endpoints. About 7000 patients will be enrolled, with an expected end date of about 2020.
With therapies now available, about half those who develop heart failure die within 5 years of diagnosis, according to Professor Hans-Juergen Woerle, global vice president of Medicine, Therapeutic Area Metabolism, Beohringer Ingelheim.
“The EMPA-REG OUTCOME trial demonstrated that Jardiance reduces the risk of cardiovascular death in diabetes patients at high cardiovascular risk, and we now look forward to exploring whether Jardiance can also provide heart failure benefits,” Woerle said in a statement.
This past weekend, Silvio E. Inzucchi, medical director for the Yale Diabetes Center, presented post-hoc analyses from EMPA-REG OUTCOME at the 66th Scientific Session of the American College of Cardiology. The reductions seen with the composite outcomes of hospitalization for heart failure (HHF) and modes of cardiovascular (CV) death seen in patients with heart failure were similar to the 34% composite seen in the prespecified composite of HHF or CV death in the original trial.