BACKGROUND: 5-HT3 receptor antagonists are being evaluated as possible agents to prevent nausea and vomiting associated with radiation exposure in a non-clinical military setting. Because of concern about potential cardiovascular toxicity and the observation that certain developmental 5-HT3 antagonists produced undesirable effects, all drugs in this class are being carefully scrutinized for possible adverse cardiac effects. METHOD: In this study, nine subjects underwent ambulatory ECG monitoring for an average of 21.6 h after a 2-mg oral dose of granisetron or placebo in a double-blind crossover protocol. Monitoring included a 3-h period of submaximal exercise in a 40 degrees C environment. RESULTS: Although isolated ventricular and supraventricular ectopic activity, sinus bradycardia, and pauses were found, there were no sustained arrhythmias observed in either the placebo or granisetron conditions. CONCLUSION: Although the generalizability of this study is limited by the small number of subjects, these observations add to the body of evidence confirming the lack of cardiovascular toxicity of granisetron.
RCT Entities:
BACKGROUND: 5-HT3 receptor antagonists are being evaluated as possible agents to prevent nausea and vomiting associated with radiation exposure in a non-clinical military setting. Because of concern about potential cardiovascular toxicity and the observation that certain developmental 5-HT3 antagonists produced undesirable effects, all drugs in this class are being carefully scrutinized for possible adverse cardiac effects. METHOD: In this study, nine subjects underwent ambulatory ECG monitoring for an average of 21.6 h after a 2-mg oral dose of granisetron or placebo in a double-blind crossover protocol. Monitoring included a 3-h period of submaximal exercise in a 40 degrees C environment. RESULTS: Although isolated ventricular and supraventricular ectopic activity, sinus bradycardia, and pauses were found, there were no sustained arrhythmias observed in either the placebo or granisetron conditions. CONCLUSION: Although the generalizability of this study is limited by the small number of subjects, these observations add to the body of evidence confirming the lack of cardiovascular toxicity of granisetron.
Authors: Guzin Gonullu; Sabri Demircan; Mustafa Kemal Demirag; Dilek Erdem; Idris Yucel Journal: Support Care Cancer Date: 2011-07-20 Impact factor: 3.603
Authors: Ozlem Yavas; Mehmet Yazici; Onder Eren; Cem Boruban; Mehmet Artac; Mine Genc Journal: Support Care Cancer Date: 2008-02-01 Impact factor: 3.603