[Ondansetron (GR 38032F), a competitive 5-HT3 receptor antagonist as an antiemetic in cytostatic drug-induced nausea and vomiting. An open, substance-oriented phase II/III study]. 1990

H Serve, and M Perker, and A Ertl, and M Reichold, and U Fink, and W E Berdel
Abteilung Hämatologie und Onkologie, Technischen Universität München.

In an open, drug-oriented phase-II/III-study 24 patients were treated with the 5-HT3-antagonist Ondansetron as an antiemetic drug for chemotherapy-induced nausea and emesis. Patients with treatment regimen containing cisplatin were excluded. All patients had suffered from severe nausea and vomiting under conventional antiemetic drugs during a previous identical chemotherapy cycle and were treated with 8 mg Ondansetron t.d. on the day of the chemotherapy and on the four following days. The drug was given with 90 cytostatic cycles ranging from 1 to 14 cycles per patient. Only 2 patients (8%) did not experience an improvement of their symptoms in any of the treatment cycles as measured by a self-conducted grading of nausea and by the frequency of vomiting in comparison to a previous treatment cycle under conventional antiemetic therapy. Eleven out of 18 patients, who were treated with Ondansetron more than once (61%) noted a diminished frequency of vomiting in each treatment cycle with Ondansetron. Sixty of the 90 therapy cycles with Ondansetron resulted in complete (no vomiting) or major (one to two vomits within 24 h following chemotherapy) protection from emesis (37 and 29 per cent, respectively). The most frequent side effect noted was obstipation (7 patients), followed by slight diffuse abdominal pain (4 patients, probably also due to chemotherapy) and slight to severe headache (3 patients, 1 patient was therefore withdrawn from the study). No other side effects were seen. In conclusion, our study indicates that Ondansetron is an effective and safe drug for the treatment of cytostatic drug-induced nausea and vomiting.

UI MeSH Term Description Entries
D007093 Imidazoles Compounds containing 1,3-diazole, a five membered aromatic ring containing two nitrogen atoms separated by one of the carbons. Chemically reduced ones include IMIDAZOLINES and IMIDAZOLIDINES. Distinguish from 1,2-diazole (PYRAZOLES).
D007262 Infusions, Intravenous The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it. Drip Infusions,Intravenous Drip,Intravenous Infusions,Drip Infusion,Drip, Intravenous,Infusion, Drip,Infusion, Intravenous,Infusions, Drip,Intravenous Infusion
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009325 Nausea An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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