Ondansetron for the prevention of emesis induced by high-dose cisplatin: a multi-center dose-response study

Article Abstract:

Nausea and vomiting (emesis) are frequent side effects of chemotherapy. At the very least, these conditions cause discomfort for the patient; medical problems arising from nausea and vomiting include anorexia and possible laceration of the esophagus. In some severe cases, the patient may refuse further chemotherapy. The most effective anti-emetic drug currently available is metoclopramide, but this drug has serious side effects. Ondansetron is a new drug that has been shown to be effective in preventing nausea and vomiting in some patients undergoing chemotherapy and has fewer side effects. To evaluate the effectiveness of different doses of ondansetron, 36 patients receiving cisplatin chemotherapy were treated with either 0.01 or 0.18 milligrams of ondansetron per kilogram of body weight. The medication was delivered in a six-dose schedule, in contrast with a three-dose schedule previously used. In the high-dose group, 41 percent of the patients had no vomiting, and an additional 24 percent had only one or two episodes. This was significantly different from the low-dose group in which 5 percent (one patient) experienced no vomiting and 21 percent experienced one or two episodes. There was no difference, however, between the six-dose regimen used in the present study and the three-dose regimen of ondansetron previously evaluated. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Drug therapy, Dosage and administration, Antiemetics, Cisplatin

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Placebos and principles: a trial of ondansetron

Article Abstract:

Ondansetron may be an effective method for preventing emesis, or vomiting, in patients undergoing chemotherapy. A research study found that ondansetron was more effective than a placebo, or an inactive substance, in preventing nausea and vomiting in patients receiving their first cycle of chemotherapy with cyclophosphamide. The only side effects experienced by patients treated with ondansetron were a mild headache and constipation. The ethics of treating some patients with a placebo may be questionable. These patients suffered more from the chemotherapy than those who were treated with ondansetron. The policy of the American Medical Association is that concern for the individual should be more important than the advancement of scientific knowledge. The patients in the placebo group could have been treated with another drug to control nausea and vomiting.

Editorial, Clinical trials, Ethical aspects

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Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy

Article Abstract:

Oral ondansetron may be an effective method for preventing emesis, or vomiting, in patients undergoing chemotherapy. Among 349 patients undergoing their first cycle of cyclophosphamide-based chemotherapy, 86 were treated with one milligram (mg) of ondansetron three times daily for three days, 89 with four mg of ondansetron, 82 with eight mg of ondansetron and 92 with a placebo, or an inactive substance. Patients treated with ondansetron experienced less nausea and vomiting than those who received a placebo. Treatment with ondansetron completely prevented vomiting in 57% of the patients treated with one mg, 65% of the patients treated with four mg and 66% of the patients treated with eight mg. Only 19% of the patients in the placebo group experienced no vomiting.

Cyclophosphamide

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