AIMS: To investigate the effect of (+)-sotalol, which is not thought to possess clinically significant beta-adrenoceptor blocking activity, on airway responsiveness in subjects with mild asthma. METHODS: A placebo controlled, double-blind, single dose, cross over study, evaluating the effects of oral (+)-sotalol 300 mg and oral (+/-)-sotalol 240 mg, on airway responsiveness, FEV1, and heart rate in 18 asthmatic volunteers with quantifiable levels of airway responsiveness. RESULTS: Compared with placebo, (+)-sotalol induced a significant increase in airway responsiveness, and a significant decrease in FEV1, but there was no significant change in heart rate. Following (+/-)-sotalol there was no significant effect on airway responsiveness, but there were significant decreases in FEV1 and heart rate. In one subject both (+)-sotalol and (+/-)-sotalol provoked a 49% decrement in FEV1, and in another there were decrements of 20% and 18%, respectively. CONCLUSIONS: Despite theoretical considerations, it cannot be assumed that (+)-sotalol is safe in patients with asthma.
RCT Entities:
AIMS: To investigate the effect of (+)-sotalol, which is not thought to possess clinically significant beta-adrenoceptor blocking activity, on airway responsiveness in subjects with mild asthma. METHODS: A placebo controlled, double-blind, single dose, cross over study, evaluating the effects of oral (+)-sotalol 300 mg and oral (+/-)-sotalol 240 mg, on airway responsiveness, FEV1, and heart rate in 18 asthmatic volunteers with quantifiable levels of airway responsiveness. RESULTS: Compared with placebo, (+)-sotalol induced a significant increase in airway responsiveness, and a significant decrease in FEV1, but there was no significant change in heart rate. Following (+/-)-sotalol there was no significant effect on airway responsiveness, but there were significant decreases in FEV1 and heart rate. In one subject both (+)-sotalol and (+/-)-sotalol provoked a 49% decrement in FEV1, and in another there were decrements of 20% and 18%, respectively. CONCLUSIONS: Despite theoretical considerations, it cannot be assumed that (+)-sotalol is safe in patients with asthma.
Authors: M Kimura; K Umemura; Y Ikeda; K Kosuge; A Mizuno; H Nakanomyo; K Ohashi; M Nakashima Journal: Br J Clin Pharmacol Date: 1996-11 Impact factor: 4.335
Authors: Zsuzsanna Callaerts-Vegh; Kenda L J Evans; Noornabi Dudekula; Donald Cuba; Brian J Knoll; Patrick F K Callaerts; Heather Giles; Felix R Shardonofsky; Richard A Bond Journal: Proc Natl Acad Sci U S A Date: 2004-04-06 Impact factor: 11.205