Abstract 10836: Ranolazine Reduces Symptoms of Palpitations and Documented Arrhytmias in Patients With Ischemic Heart Disease
Background: Ranolazine decreases the frequency of arrhythmias during the acute phases of IHD, but it remains unknown if it has similar effects in the chronic phase. We performed a prospective, randomized, cross-over pilot trial to test the hypothesis that chronic treatment with ranolazine can reduce the incidence of documented arrhythmias and the related symptoms of palpitation in patients (pts) with stable IHD.
Methods: We randomized 105 pts with stable IHD and symptoms of angina and palpitations already on therapy with b blockers to ranolazine (750 mg bid, N=53) or placebo (N=52) for 30 days (until T-1). After a wash-out period to avoid any carryover effect, cross-over was performed,and pts were switched to the other drug which was continued for 30 days (until T-2). All pts underwent exercise stress testing and 48-hour ECG Holter at T1 and T2. During the study period, pts were told to use a OmronN® portable ECG HCG-801 in case of symptoms of palpitations.
Results: Ranolazine reduced the number of anginal episodes more than placebo (5±8 episodes/30 days vs. 21±24 episodes/30 day, p=0.001) and increased exercise durations at 1 mm ST-segment depression (514±211 s vs. 402±287 s, p=0.025) and at onset of angina (614±199 s vs. 519±151 s, p=0.007) at stress testing.
These effects were coupled by significant decreases with ranolazine as compared with placebo treatment periods in the occurrence of frequent (>1,000 beats) supraventricular arrhythmias (33% vs 52%, p=0.01) and complex ventricular arrhythmias (17% vs 30%, p=0.045). Complete resolution of symptoms of palpitations was significantly more common with ranolazine than placebo (31/53 vs 16/52 patients, p=0.008). Also, portable ECG recordings showed that arrhythmias were less common during ranolazine vs. placebo, with significant decreases in number (7±10 episodes/30 days vs. 23±29 episodes/30 day, p=0.001) and duration (10±18 min/30 days vs. 19±21 min/30 day, p=0.021) of symptomatic arrhythmic episodes.
Conclusion: The antianginal and antiischemic properties of ranolazine are paralleled by significant decreases in the occurrence of both arrhythmias and the related symptoms of palpitations in stable pts with IHD. (ClinicalTrials.gov NCT01495520)
- © 2013 by American Heart Association, Inc.