THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced that it presented data from the Phase 3 SHIFT or Systolic Heart failure treatment with the If inhibitor ivabradine Trial study, which evaluated ivabradine in patients with chronic heart failure or HF, at the 18th Annual Scientific Meeting of the Heart Failure Society of America or HFSA in Las Vegas.
A post-hoc analysis from the SHIFT study confirmed low systolic blood pressure or SBP is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP. Safety was similar across the three SBP groups.
Results were published in the July 2014 issue of the European Journal of Heart Failure.
Ivabradine is an oral drug that inhibits the If current ('funny' current) in the sinoatrial node, the body's cardiac pacemaker. It works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.
In August 2014, the U.S. Food and Drug Administration or FDA granted ivabradine priority review designation, which is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions compared to available therapies. FDA will target a priority review Prescription Drug User Fee Act (PDUFA) action date of Februay 27, 2015.
Additional findings presented at the HFSA meeting included data from a pre-specified Holter electrocardiography sub-study (ECG-Holter sub-study), which evaluated 501 patients from the SHIFT trial to better understand the relationship between heart rate and safety/incidence of adverse events while taking ivabradine on top of optimized HF therapy, including beta blockers.
Results showed that at eight months, 24-hour heart rate was significantly reduced by 9.5 + 10.1 bpm in the ivabradine group (n=254) versus 1.2 + 8.9 bpm in the placebo group (n=247) (p<0.0001). Higher rates of at least one episode of heart rate less than 40 bpm were also reported in the ivabradine group (p<0.0001). No increase in significant pauses, second/high degree atrioventricular block or arrhythmias was observed in the ivabradine group in this sub-study.
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