ABSTRACT
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.