A new beta adrenergic blocking agent, sotalol, in the treatment of angina pectoris. A double blind-crossed treatment study.
The present therapy for coronary insufficiency includes the use of drugs which decrease the cardiac work, thus reducing the needs for oxygen (beta adrenergic blocking agents). The 4- (2-isopropylamino-1-hydroxyethil) methane sulfonamylide (Sotalol (R)) is considered the most active of the alkylsulfonamide phethenolamines group. 69 patients with angina pectoris were selected for treatment with Sotalol. The administration was preceded by a five weeks period during which the patients received placebo. Afterwards they received for three weeks a dose of Sotalol (titration period), set the optimal effective dose. At the end of this period all patients began a double blind-crossed treatment which continued for 12 weeks. Two schedules were followed: group 1, Sotalol-placebo; group 2, placebo-Sotalol. No statistically significant variations were shown in the number of anginose attacks during the initial placebo period. The decline in the number of anginose attacks during the titration period (Group 1: weeks 5 to 8, p less than 0.0001; Group 2: weeks 5 to 8, p less than 0.0002) is statistically significant. In the first group the continued administration of Sotalol decreased the number of painful attacks even further, which describe a slope which is abruptly interrupted at the end of the six weeks, coinciding with the initiation of the placebo treatment (Group 1: weeks 8 to 14, p less than 0.001, significant). In group 2 (drug-placebo-drug) the administration of the placebo in the six weeks following the titration period was followed by a recrudescence of the symptomatology, whose intensity, however remained far below that recorded during the initial period (Group 2: weeks 8 to 14, p less than 0,0783, not significant). Then, in the final six weeks, the administration of Sotalol produced a sustained and considerable improvement in the weekly number of anginose attacks (Group 2: weeks 14 to 20, p less than 0.0011, significant). All the differences produced by the ingestion of Sotalol are statistically significant. These facts, together with the absence of clinical or humoral side effects incontestably bear out the efficacy of the drug in controlling the number and the intensity of painful attacks of coronary origin.
D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D013015:Sotalol / Q000627:therapeutic use*
D010919:Placebos; D013015:Sotalol