Document Detail


The cardiovascular safety of high-dose intravenous granisetron in cancer patients receiving highly emetogenic chemotherapy.
MedLine Citation:
PMID:  14634790     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: To assess the cardiovascular safety, tolerability and efficacy of high doses of granisetron for the treatment of nausea and vomiting in patients undergoing highly emetogenic chemotherapy. METHODS: Patients with histologically confirmed malignant disease were given an intravenous infusion of granisetron, 160 microg/kg, over 30 min, starting 15 min after highly emetogenic chemotherapy. Patients underwent cardiac monitoring for 24 h following the granisetron infusion. Pulse, blood pressure and electrocardiogram (lead II and ambulatory) measurements were taken, and routine clinical chemistry and haematology tests performed. Blood samples for pharmacokinetic analysis were taken before the granisetron infusion, and at intervals afterwards. Adverse events were self-assessed using a symptom checklist. Self-assessment categorical rating scales were used to evaluate patient nausea, vomiting and retching. RESULTS: Ten patients (eight females and two males; average age 41.5 years) completed the trial and were included in the safety and efficacy assessments. No clinically relevant changes in electrocardiogram, pulse rate, blood pressure or laboratory parameters were observed. Furthermore, in the 7 days following dosing there were no serious adverse events leading to withdrawal from the trial. A complete response (no vomiting, retching or, at most, mild nausea) was experienced by five patients. Six patients had no, or mild, nausea and an additional two patients vomited on a maximum of two occasions. Additional antiemetic rescue medication was given to three patients during the 24-h trial period. Despite considerable interpatient variability, C(max) and AUC parameters were proportionally greater than values reported for lower doses of granisetron. CONCLUSIONS: Granisetron administered at four times the upper recommended dose demonstrated good efficacy and tolerability with no clinically important cardiac effects.
Authors:
James Carmichael; Adrian L Harris
Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2003-11-22
Journal Detail:
Title:  Cancer chemotherapy and pharmacology     Volume:  53     ISSN:  0344-5704     ISO Abbreviation:  Cancer Chemother. Pharmacol.     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2003-12-23     Completed Date:  2004-03-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7806519     Medline TA:  Cancer Chemother Pharmacol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  123-8     Citation Subset:  IM    
Affiliation:
Department of Clinical Oncology, City Hospital, University of Nottingham, Cancer Research UK, Hucknall Road, Nottingham, NG5 1PB, UK.
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MeSH Terms
Descriptor/Qualifier:
Adult
Antiemetics / adverse effects*,  pharmacokinetics,  therapeutic use
Antineoplastic Agents / adverse effects*
Area Under Curve
Cardiovascular Diseases / chemically induced*,  epidemiology
Electrocardiography / drug effects
Female
Granisetron / adverse effects*,  pharmacokinetics,  therapeutic use
Half-Life
Humans
Male
Middle Aged
Nausea / chemically induced,  psychology
Neoplasms / complications
Vomiting / chemically induced*,  drug therapy*
Chemical
Reg. No./Substance:
0/Antiemetics; 0/Antineoplastic Agents; 109889-09-0/Granisetron

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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