Gilead:Study Shows Reduction In AFB With Combination Of Ranolazine & Dronedarone

(RTTNews) - Gilead Sciences Inc. (GILD) announced results from HARMONY, a randomized, double-blind, placebo-controlled Phase 2 study evaluating the effect of ranolazine and low-dose dronedarone, each given alone and in combination, on atrial fibrillation burden or AFB in patients with paroxysmal atrial fibrillation or AF.

In HARMONY, the combination of ranolazine and low-dose dronedarone provided greater reductions in AFB from baseline than either therapy used alone.

Ranolazine is approved in the United States under the tradename Ranexa for the treatment of chronic angina at marketed doses of 500 mg and 1,000 mg twice daily. Ranexa with or without dronedarone is not approved for the treatment of AF.

"HARMONY suggests that a new therapeutic approach of combining ranolazine and low-dose dronedarone is more effective than either therapy alone in lowering AF burden. Pending larger Phase 3 evaluation, a combination of ranolazine and low-dose dronedarone has the potential to help address a significant and growing unmet need for additional treatment options for people living with this serious disease," said Peter Kowey, MD, William Wikoff Smith Chair in Cardiovascular Research, Lankenau Medical Center and Professor of Medicine and Clinical Pharmacology, Jefferson Medical College, Thomas Jefferson University.

The primary endpoint was change in AFB over 12 weeks. AFB was defined as the total time a patient was in atrial tachycardia/atrial fibrillation expressed as percentage of total recording time continuously from 0 to 12 weeks.

Atrial Fibrillation is the most common type of abnormal heartbeat, or arrhythmia. It is caused by abnormal electrical discharges in the atria (upper two chambers of the heart), which prevent the heart from pumping blood normally, and usually causing the heart to beat too rapidly.