FDA Approves New Heart Failure Drug
On April 15, 2015, Amgen announced that the FDA approved Corlanor (ivabradine) for the treatment of stable heart failure (HF) in patients with left ventricular ejection fraction ≤35% and a normal resting heart rate ≥70 beats per minute (BPM) who are receiving maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Corlanor is a hyperpolarization-activated cyclic nucleotide-gated channel blocker.
The efficacy of Corlanor was demonstrated in three clinical studies. The SHIFT trial had 6505 participants with stable HF, left ventricular ejection fraction ≤35%, and a resting heart rate ≥70 BPM. Of these participants, 3241 were randomized to receive Corlanor, and 3264 were randomized to receive placebo in addition to standard-of-care treatment. Patients accepted to the trial had to have reported a hospitalization for HF within 12 months prior to entering the study.
Corlanor reduced the risk of the combined endpoint of hospitalization for worsening HF or cardiovascular death based on a time-to-event analysis. The SHIFT trial demonstrated a hazard ratio of .82 (95% confidence interval, .75–.90, P<.0001).
The most common adverse events that occurred in participants receiving Corlanor compared to placebo were bradycardia (10% compared to 2.2%, respectively), hypertension/increase in blood pressure (8.9% compared to 7.8%, respectively), and atrial fibrillation (8.3% compared to 6.6%, respectively).
The study found no pharmacokinetic differences in participants ≥65 years of age or in participants ≥75 years compared to the overall population. The researchers did note that there were a limited number of patients ≥75 years of age.
