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HARMONY: Ranolazine, dronedarone combination benefits patients with paroxysmal AF
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Published data from the HARMONY trial confirm a previous report that moderate-dose ranolazine plus reduced-dose dronedarone was well-tolerated and reduced atrial fibrillation burden, according to a report in Circulation: Arrhythmia & Electrophysiology.
The researchers previously presented their findings at the 2014 Heart Rhythm Society Annual Scientific Sessions.
Peter R. Kowey
Peter R. Kowey, MD, FACC, FHRS, professor of medicine and clinical pharmacology at Jefferson Medical College, Philadelphia, and chief of cardiology and William Wilkoff Chair in Cardiovascular Research at Lankenau Heart Institute, Wynnewood, Pennsylvania, and colleagues conducted a phase 2 trial of the antianginal drug ranolazine (Ranexa, Gilead Sciences) 750 mg twice daily and the anti-AF drug dronedarone (Multaq, Sanofi Aventis) 150 mg or 225 mg twice daily in 134 patients with paroxysmal AF and a pacemaker (mean AF burden at baseline, 17.4%).
Kowey, Arrhythmia Disorders Section Editor of Cardiology Today, and colleagues randomly assigned patients to receive placebo, ranolazine 750 mg twice daily alone, dronedarone 225 mg twice daily alone, ranolazine 750 mg plus dronedarone 150 mg twice daily or ranolazine 750 mg plus dronedarone 225 mg twice daily.
The primary outcome was absolute and percent change in AF burden after 12 weeks of treatment.
At 12 weeks, those assigned or ranolazine 750 mg plus dronedarone 225 mg twice daily had a greater reduction in AF burden compared with those assigned placebo (59%; P = .008), those assigned dronedarone 225 mg twice daily alone (P = .002) and those assigned ranolazine 750 mg twice daily alone (P = .049), according to the researchers.
Those assigned ranolazine 750 mg plus dronedarone 150 mg twice daily had trend toward greater reduction in AF burden compared with those assigned placebo (43%; P = .072), they found.
The placebo group, the dronedarone alone group and the ranolazine alone group did not achieve a statistically significant reduction in AF burden, Kowey and colleagues found.
Treatment-related adverse events, serious adverse events and adverse events that led to discontinuation were similar between the ranolazine/dronedarone groups and the ranolazine alone and dronedarone alone groups, according to the researchers.
“This profile appears to offer promise for AF patients and suggests that the concept of combining two [antiarrhythmic drugs] with complementary ion channel blocking properties is worthy of testing in a larger, more patient-diverse population,” Kowey and colleagues wrote. – by Erik Swain
Disclosure: The study was funded by Gilead Sciences. Kowey and two other researchers report consulting for Gilead Sciences and Sanofi. Two other researchers report receiving research grants from Gilead Sciences and four others report being employed by Gilead Sciences.
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