title: Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.
abstract: OBJECTIVE
  Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics.
  
  
  METHODS
  In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion.
  
  
  RESULTS
  A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion.
  
  
  CONCLUSIONS
  As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.
authors.affiliation: Department of Pediatric Hematology-Oncology, Bezmialem University Medical Center, Istanbul, Turkey.
authors.forename: F B
authors.initials: FB
authors.lastname: Cakir
authors.forename: O
authors.initials: O
authors.lastname: Yapar
authors.forename: C
authors.initials: C
authors.lastname: Canpolat
authors.forename: F
authors.initials: F
authors.lastname: Akalin
authors.forename: S G
authors.initials: SG
authors.lastname: Berrak
mesh_terms: D000293:Adolescent; D000932:Antiemetics / Q000009:adverse effects* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects; D001919:Bradycardia / Q000139:chemically induced*; D002648:Child; D002675:Child, Preschool; D003402:Creatine Kinase / Q000097:blood; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D017829:Granisetron / Q000009:adverse effects* / Q000627:therapeutic use; D006321:Heart / Q000187:drug effects*; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000188:drug therapy; D011446:Prospective Studies; D020107:Troponin T / Q000097:blood; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D003402:Creatine Kinase; D017829:Granisetron; D020107:Troponin T