[Antiarrhythmic drug effectiveness. Proposal for a new approach based on pharmacological hourly effects]. / Efficácia das drogas antiarrítmicas. Proposta para uma nova forma de avaliação baseada nos efeitos farmacológicos horários.

PURPOSE: To use a new approach in order to assess the antiarrhythmic drugs, based in the hourly autonomic effects and antiarrhythmic efficacy of sotalol. METHODS: Sixteen patients were evaluated in a randomized double-blind placebo-controlled study. Patients were classified in group 1 (anti-arrhythmic efficacy) and group 2 (no antiarrhythmic efficacy). The following parameters were analyzed: 1) clinical variables as age, gender, cardiac disease and ventricular ectopies density; 2) drug effects on pNN50 in 24-hour and on mean hourly cardiac cycle length; 3) percentage of hourly ventricular ectopies distribution and its correlation with pNN50 and with mean hourly cardiac cycle length in all patients; 4) drug effects on mean hourly cardiac cycle length in groups 1 and 2; 5) correlation between hourly pNN50 and ventricular ectopies density after sotalol administration in groups 1 and 2; 6) hourly drug efficacy in groups 1 and 2 and correlation with pNN50. RESULTS: Efficacy of the drug was present in 8 (50%) patients. Sotalol significantly increased 24-hour pNN50 (placebo 5.01 +/- 2.02%; after drug, 11.70 +/- 5.59%-p < 0.001), also increasing mean hourly cardiac cycle length during the day and night, in all patients (placebo 758.25 +/- 75.68 ms; after drug 967.71 +/- 80.17 ms-p < 0.000). It was noted that patients under placebo had different autonomic tonus; group 1 showed higher sympathetic activity as compared to group 2. Hourly drug efficacy was seen in 23 of 24-hour recordings in group 1 while it was not seen at any time in group 2. CONCLUSION: Sotalol significantly increased parasympathetic cardiac activity. The anti-arrhythmic response was related to the autonomic tonus seen before and after drug administration.

[Brazilian multicenter study of sotalol effectiveness in ventricular arrhythmias]. / Estudo multicêntrico Brasileiro da eficácia do sotalol em arritmias ventriculares.

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.

Estudo multicêntrico brasileiro da eficácia do sotalol em arritmias ventriculares / Brazilion Multicenter Study of Sotalol Effectiveness in Ventricular Arrhythmias

Objetivo - Avaliar através de ensaio clínico prospectivo, randomizado, duplo-cego cruzado contra placebo, a eficácia do sotalol na dose oral de 320 miligramas diários em reduzir taquiarritmias ventriculares näo sustentadas (TVNS). Métodos - Foram avaliados em condiçöes de controle (Ct), placebo (Pb) e droga (Dg), 90 portadores de um número médio maior ou igual a 50 extra-sístole horárias (EV), com ou sem respostas pareadas (RP) e TVNS, registradas no Holter. Considerou-se a droga como efetiva, fren a uma reduçäo maior ou igual a 75 por cento das EV e maior ou igual a 90 por cento das RP e TVNS. Avaliaram-se os resultados globais e os observados em doenças específicas, incluindo a cardiopatia chagásica crônica, arritmias ventriculares idiopáticas e doença coronariana e hipertensiva sistêmica. Resultados - Näo ocorreram diferenças significativas entre Ct e Pb. Globalmente, a droga reduziu as EV em 42 por cento (38/90 pacientes), as RP em 48 por cento (32/67 e as TVNS em 53 por cento (19/36), com méis respectivas entre Pb e Dg de 11.770 mais ou menos 13.818 para 1.043 mais ou menos 1.554 nas EV (p menor a 0,001); de 439 mais ou menos 586 para 27 mais ou menos 52 nas RP (p menor a 0,001) e de 445 mais ou menos 1.147 para 2,5 mais ou menos 5,8 nas TVNS (p menor a 0,102). Nos chagásicos, reduçäo das EV de 33 por cento (13/39 pacientes), das RP em 42 por cento (14/34) e das TVNS em 64 por cento (12/22). Nos indiopáticos, a reduçäo das EV foi de 53 por cento (17/32 pacientes), das RP de 50 por cento (0/0) e das TVNS de 36 por cento (4/11). Nos isquêmicos e/ou hipertensos, a reduçào das EV foi de 47 por cento (7/15 pacientes) e de 73 por cento nas RP (8/11). Conclusäo - Na populaçäo estudada e na dose indicada, o sotalol mostrou ser um fármaco efetivo para controle de TVNS, apresentando mínimos efeitos colaterais.