Brazilian multicenter study of sotalol effectiveness in ventricular arrhythmias

PURPOSE: To evaluate the effects of sotalol in patients with nonsustained ventricular tachyarrhythmia (NSVT). METHODS: Ninety patients were enrolled. Patients were submitted to a double-blind crossover randomized study (placebo x 320 ms/po/d/sotalol; 4 weeks, after a wash-out control period. Holter recordings were performed in control (Ct), placebo (Pb) and drug (Dg) periods. Eligible patients had > 50/h isolated ventricular premature beats (VPB), in control, with or without pairs (P) or nonsustained VT (NSVT; > 3 beats, > 100bpm). Drug efficacy criteria were; > or = 75% reduction in isolated VPB, reduction > or = 90% of P and NSVT. The effects of the Dg were evaluated in the global population, in patients with Chagas' disease, idiopathic arrhythmias and ischemic/hypertensive patients. RESULTS: Differences between control and placebo were NS. Isolated VPB; Dg was effective in 42% (38/90 patients) with a mean of Pb and Dg respectively of 11,770 +/- 13,818 and 1,043 +/- 1,554 (p < 0.001). Pairs: drug was effective in 48% (32/67 patients) with a mean of Pb and Dg respectively of 439 +/- 586 and 27 +/- 52 (p < 0.001). NSVT: drug effectiveness was 53% (19/36 patients) with a mean of Pb and Dg respectively of 445 +/- 1,148 and 2.5 +/- 5.8 (p < 0.102). In patients with Chagas' disease, the reduction in VPB was 33% (13/39 patients), in pairs was 42+ (14/34) and in NSVT was 64% (12/22). In idiopathic patients the reduction of VPB was 53% (17/32 patients), in pairs was 50% (10/20) and in NSVT was 36% (4/11). In ischemic and hypertensive patients the reduction of VPB was 47% (7/15 patients) and 73% in pairs (8/11). CONCLUSION: In the present study, sotalol was effective in the control of nonsustained ventricular tachyarrhythmia, with minimal side-effects.