BACKGROUND AND OBJECTIVE:Ivabradine is a novel pure heart rate-lowering agent that selectively and specifically inhibits pacemaker I(f) current. Ivabradine has been shown to have antianginal and anti-ischaemic properties in patients with stable angina pectoris. Because f channels are also present in the retina, visual symptoms represent a potential adverse effect of ivabradine that may affect driving performance. The aim of the study was to investigate whether visual symptoms reported after repeated administration of ivabradine at high doses could affect driving performance. METHODS: This randomized, double-blind, placebo-controlled study was conducted in healthy volunteers. Seventy-five subjects were randomized to ivabradine 10 mg twice daily and 15 subjects to placebo for 7 days, followed by ivabradine 15 mg twice daily or placebo, respectively, for a second week if no visual symptoms were reported. As soon as a subject reported visual symptoms between day 1 and day 14, he or she was assigned to perform driving simulator sessions. If no visual symptoms were reported, driving simulator sessions were performed after 14 days' treatment. Driving parameters included absolute speed, deviation from the speed limit, deviation from the ideal route and number of collisions in different light conditions. RESULTS: In the daylight and evening driving sessions, there was no significant difference in all measured parameters (as indicated by absolute speed, deviation from the speed limit and deviation from the ideal route results) between the ivabradine and the placebo groups, independently of visual symptoms. No collisions were observed in the entire study irrespective of the testing conditions and the treatment groups assessed. No relevant differences were seen in the ivabradine subsets of subjects reporting visual symptoms or not. CONCLUSION: This study suggests that ivabradine administered at dosages higher than those recommended in the clinic did not affect driving performance regardless of whether or not visual symptoms were present.
RCT Entities:
BACKGROUND AND OBJECTIVE:Ivabradine is a novel pure heart rate-lowering agent that selectively and specifically inhibits pacemaker I(f) current. Ivabradine has been shown to have antianginal and anti-ischaemic properties in patients with stable angina pectoris. Because f channels are also present in the retina, visual symptoms represent a potential adverse effect of ivabradine that may affect driving performance. The aim of the study was to investigate whether visual symptoms reported after repeated administration of ivabradine at high doses could affect driving performance. METHODS: This randomized, double-blind, placebo-controlled study was conducted in healthy volunteers. Seventy-five subjects were randomized to ivabradine 10 mg twice daily and 15 subjects to placebo for 7 days, followed by ivabradine 15 mg twice daily or placebo, respectively, for a second week if no visual symptoms were reported. As soon as a subject reported visual symptoms between day 1 and day 14, he or she was assigned to perform driving simulator sessions. If no visual symptoms were reported, driving simulator sessions were performed after 14 days' treatment. Driving parameters included absolute speed, deviation from the speed limit, deviation from the ideal route and number of collisions in different light conditions. RESULTS: In the daylight and evening driving sessions, there was no significant difference in all measured parameters (as indicated by absolute speed, deviation from the speed limit and deviation from the ideal route results) between the ivabradine and the placebo groups, independently of visual symptoms. No collisions were observed in the entire study irrespective of the testing conditions and the treatment groups assessed. No relevant differences were seen in the ivabradine subsets of subjects reporting visual symptoms or not. CONCLUSION: This study suggests that ivabradine administered at dosages higher than those recommended in the clinic did not affect driving performance regardless of whether or not visual symptoms were present.
Authors: A Iudice; E Bonanni; M Maestri; B Nucciarone; S Brotini; L Manca; G Iudice; L Murri Journal: Int J Clin Pharmacol Ther Date: 2002-07 Impact factor: 1.366