HealthDay News — Ularitide has a favorable physiological effect in patients with acute heart failure, according to a study published online in the New England Journal of Medicine.
Milton Packer, MD, from the Baylor University Medical Center in Dallas, and colleagues conducted a double-blind trial involving 2,157 patients with acute heart failure who were randomized to receive a continuous intravenous infusion of ularitide (15 ng/kg body weight/minute) or matching placebo for 48 hours in addition to standard therapy.
The researchers found that 236 patients in the ularitide group and 225 in the placebo group died of cardiovascular causes during a median follow-up of 15 months (21.7% vs 21%; hazard ratio [HR]: 1.03; 95% CI, 0.85-1.25; P =.75). There was no significant difference between the groups with respect to the hierarchical composite outcome that evaluated the initial 48-hour clinical course. Compared with the placebo group, the ularitide group had greater reductions in systolic blood pressure and in levels of N-terminal pro-brain natriuretic peptide. In the 55% percent of patients with paired data, there was no difference between the groups in changes in cardiac troponin T levels during the infusion.
“In patients with acute heart failure, ularitide exerted favorable physiological effects (without affecting cardiac troponin levels), but short-term treatment did not affect a clinical composite end point or reduce long-term cardiovascular mortality,” the authors write.
The study was funded by Cardiorentis, which is developing ularitide.
- Packer M, O’Connor CO, McMurray JJV, et al; for the TRUE-AHF Investigators. Effect of ularitide on cardiovascular mortality in acute heart failure [published online April 12, 2017]. N Engl J Med. doi: 10.1056/NEJMoa1601895
- Hauptman PJ. Disease modification in acute decompensated heart failure [published online April 12, 2017]. N Engl J Med. doi: 10.1056/NEJMe1613708