Linked Life Data

8911112

Source:http://linkedlifedata.com/resource/pubmed/id/8911112

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
9
pubmed:dateCreated
1996-12-2
pubmed:abstractText
This multicentre, randomised, double-blind study was designed to compare the anti-emetic efficacy and safety of single oral doses of dolasetron mesilate with that of the approved oral, multiple-dose regimen of ondansetron in 399 cancer patients receiving moderately emetogenic chemotherapy. Single oral doses of 25, 50, 100 or 200 mg of dolasetron mesilate were administered 1 h prior to the initiation of moderately emetogenic chemotherapy. Multiple doses of ondansetron (8 mg x 3 or 8 mg x 4) capsules, or matching placebo for patients randomised to dolasetron, were given 1.5 h before and 6.5, 14.5 and 22.5 h after the start of chemotherapy (total dose = 32 mg). Efficacy was evaluated for 24 h after the initiation of chemotherapy. The most frequently used moderately emetogenic chemotherapeutic agents included cyclophosphamide, doxorubicin and carboplatin (28.4, 23.1 and 20.6% of patients, respectively). A statistically significant (P < 0.001) linear dose-response relationship was observed over the entire dolasetron dosage range for all efficacy parameters. Complete response rates were 45.0, 49.4, 60.5 and 76.3% for 25, 50, 100 and 200 mg dolasetron mesilate, respectively, and 72.3% of ondansetron patients. A single oral 200 mg dolasetron mesilate dose was therapeutically equivalent to ondansetron for all efficacy parameters and patient satisfaction was high. Overall, there were no significant differences in the incidence of adverse events between any of the dolasetron mesilate doses, or between dolasetron and ondansetron. Headache was most frequently reported (approximately 15% for each drug). No clinically important changes in vital signs or clinical laboratory parameters were observed with either drug. In conclusion, a single oral 200 mg dolasetron mesilate dose was therapeutically equivalent to multiple-dose ondansetron in the prevention of emesis and nausea following moderately emetogenic chemotherapy.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Aug
pubmed:issn
0959-8049
pubmed:author
pubmed:issnType
Print
pubmed:volume
32A
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1523-9
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:8911112-Adult, pubmed-meshheading:8911112-Aged, pubmed-meshheading:8911112-Analysis of Variance, pubmed-meshheading:8911112-Antiemetics, pubmed-meshheading:8911112-Antineoplastic Agents, pubmed-meshheading:8911112-Dose-Response Relationship, Drug, pubmed-meshheading:8911112-Double-Blind Method, pubmed-meshheading:8911112-Female, pubmed-meshheading:8911112-Headache, pubmed-meshheading:8911112-Humans, pubmed-meshheading:8911112-Indoles, pubmed-meshheading:8911112-Logistic Models, pubmed-meshheading:8911112-Male, pubmed-meshheading:8911112-Middle Aged, pubmed-meshheading:8911112-Nausea, pubmed-meshheading:8911112-Neoplasms, pubmed-meshheading:8911112-Ondansetron, pubmed-meshheading:8911112-Patient Satisfaction, pubmed-meshheading:8911112-Quinolizines, pubmed-meshheading:8911112-Risk Factors, pubmed-meshheading:8911112-Therapeutic Equivalency, pubmed-meshheading:8911112-Vomiting
pubmed:year
1996
pubmed:articleTitle
Therapeutic equivalence of single oral doses of dolasetron mesilate and multiple doses of ondansetron for the prevention of emesis after moderately emetogenic chemotherapy. European Dolasetron Comparative Study Group.
pubmed:affiliation
Klinik für Hämatologie/Onkologie and Knochenmarktransplantation, Oberstein, Germany.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study