Francisco D’Avella, MD, president of the European Society of Cardiology and a cardiologist with Lava Therapeutics (FCT), will present results from the Phase II clinical trial, dapagliflozin (efibabroche) vs placebo (PWI), at The Duke Clinical Research Research Programt (DCRP) 2020. It is among the top trials being conducted, in order, to date in North America.
“This is the first time that a potential primary outcome of the trial for patients with cardiovascular disease is being assessed using a endpoint value point in an established clinical trial. It is also the first time that dapagliflozin (efibabroche) has been used in this way in such a large patient population,” said Ramalles Dias, MD, professor of medicine at Duke–Louis University Health Care (DUKH). “We expect this definitive efficacy study, as well as its long-term effects, will guide the management of the diabetes disease in America.””This would be an immense boon for FDA and academic institutions that have been advising against prescribing beta cell blockers for the treatment of CHD in recently diagnosed patients with diabetes,” said Dr. Dias. “In general, I am encouraged that a large, randomized, placebo controlled trial to determine the relative benefits and harms of dapagliflozin vs. placebo in patients with cardiovascular diseases will be conducted in the future—though I am most optimistic that our existing studies will provide definitive answers.” Patients with coronary artery disease already have a small risk of developing cardiovascular disease that substantially increases their probability of dying within 30 years of diagnosis.
The new multicenter trial is currently under way. The study will compare the new, more involved approach to dapagliflozin (efibabroche) vs. placebo (PWI) in 37 patients with type 1–2 CHD and is being jointly funded by Lava Therapeutics and Duke Clinical Research Program. The trial is led by Roland Gingass, of Lava Therapeutics, in collaboration with Christophe Bourquhoun and Jacques Drouin, both of the department of nutrition and food science, Duke University School of Medicine. “Our goal is to detect the most important endpoint of frequently-used beta-blockers: a benefit-relative rate of 7 or 8 relative to placebo in patients with CHD. We believe this result will be used to guide the use of new, more effective agents, including beta blockers,” said Dr. Dias. Additional results from a phase 3 clinical trial will be presented at the meeting.