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FDA Approves New Heart Failure Drug


Annals of Long-Term Care: Clinical Care and Aging. 2015;23(5):34


Melissa D. Cooper

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.

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