Investigational Ivabradine Treatment Improves Chronic Heart Failure Outcomes

September 15, 2014
Krystle Vermes

New late-stage trial data show ivabradine reduces cardiovascular death or hospitalization for worsening chronic heart failure in patients with low systolic blood pressure.

New late-stage trial data released by Amgen at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) showed ivabradine reduces cardiovascular death or hospitalization for worsening chronic heart failure (HF) in patients with low systolic blood pressure (SBP).

According to Amgen, the oral investigational drug “works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.”

"Despite standard of care, chronic HF remains a disabling condition with a poor prognosis for patients at risk for hospitalization," said Sean Harper, MD, executive vice president of research and development at Amgen, in a press release. "Analyses from the pivotal Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial (SHIFT) study complement the main trial findings that form the basis of our US submission package for ivabradine.”

That submission package received priority review designation from the FDA last month, which Dr. Harper previously said serves as “evidence that chronic HF is a serious condition, which leads to high rates of rehospitalization and poor prognosis, despite available treatments.”

“If approved, ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies, for this grievous condition," Dr. Harper noted in a previous press release.

The Phase 3 SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6500 patients with symptomatic chronic HF in sinus rhythm with reduced left ventricular function and a heart rate of >70 beats per minute. The results of a post-hoc analysis of the randomized, double-blind, placebo-controlled outcomes trial presented at the HFSA scientific meeting established similar drug safety profiles across 3 different SBP groups.

"Low blood pressure is a common condition in chronic HF that complicates management and is associated with negative outcomes such as death and hospitalization," said Jeffrey Borer, MD, professor of medicine, cell biology, radiology, and surgery at the State University of New York. "The analysis from the SHIFT study showed consistent results regardless of SBP, which provides further evidence that ivabradine has the potential to improve clinical outcomes, on top of standard therapy, in certain patients with chronic HF."