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|FDA Approves Corlanor® (ivabradine) To Reduce The Risk Of Hospitalization For Worsening Heart Failure In Patients With Chronic Heart Failure|
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Heart failure is a common condition that affects approximately 5.7 million people in the U.S., about half of which have reduced left ventricular function.1,2 Despite broad use of standard treatments, the prognosis for patients with heart failure is poor.3 Projections show that by 2030, the prevalence of heart failure will increase 46 percent from 2012 estimates.1
"We are excited to introduce Corlanor, the first new chronic heart failure medicine approved by the
Heart failure costs an estimated
"The approval of Corlanor is an important step forward for the treatment of patients with chronic heart failure in the U.S. Because its mechanism of action is unique, it will complement the use of standard heart failure therapies, including beta blockers," said
Corlanor blocks the hyperpolarization-activated cyclic nucleotide-gated (HCN) channel responsible for the cardiac pacemaker, which regulates heart rate. Corlanor reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current ("funny" current) to slow the heart rate with no effect on ventricular repolarization and no effects on myocardial contractility.5
The Corlanor approval is based on global clinical trial data including a large, multicenter, randomized, double-blind, placebo-controlled, outcomes trial. The Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study compared Corlanor to placebo on top of standard of care (SOC) therapies, including beta blockers, in more than 6,500 clinically stable (≥4 weeks) patients in sinus rhythm with reduced left ventricular function (LVEF ≤35 percent) and heart rate ≥70 bpm, with a hospitalization for heart failure within the past 12 months. Patients received SOC, including beta blockers (89 percent), angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blockers (ARB) (91 percent), diuretics (83 percent) and anti-aldosterone agents (60 percent).
Results from the Phase 3 SHIFT study showed Corlanor significantly reduced the risk of the primary composite endpoint of hospitalization or cardiovascular death for worsening heart failure, with 18 percent relative risk reduction (RRR) (p<0.0001, 4.2 percent absolute risk reduction [ARR]) versus placebo. The treatment effect reflected only a reduction in the risk of hospitalization for worsening heart failure; there was no favorable effect on the mortality component of the primary endpoint. There was a 26 percent RRR (4.7 percent ARR) in the risk of hospitalizations for worsening heart failure.
The most common adverse drug reactions in the SHIFT study occurring in ≥1 percent of patients on Corlanor compared to placebo were bradycardia (10 percent vs. 2.2 percent), hypertension or increased blood pressure (8.9 percent vs. 7.8 percent), atrial fibrillation (8.3 percent vs. 6.6 percent), and luminous phenomena (phosphenes) or visual brightness (2.8 percent vs. 0.5 percent).
The recommended starting dose of Corlanor is a 5 mg tablet twice daily with meals. After two weeks of treatment, the dose should be assessed and adjusted depending on heart rate. In patients with a history of conduction defects, or other patients in whom bradycardia could lead to hemodynamic compromise, initiate therapy at 2.5 mg twice daily before increasing the dose based on heart rate.
Corlanor is expected to be available to patients in approximately one week.
About Corlanor® (ivabradine)
Important U.S. Product Information
Important Safety Information
Please contact Amgen Medinfo at 800-77-
About Amgen Cardiovascular
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