Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Ondansetron is a 5-HT3 receptor antagonist which has shown activity in the prevention of nausea and vomiting resulting from cytotoxic therapy. This paper describes the results of studies evaluating the efficacy of oral ondansetron in controlling radiation-induced emesis. Initial non-randomised studies showed that doses of 4 mg q.d.s. or 8 mg t.d.s. of ondansetron achieved complete or major control of vomiting in 77-91% of patients and mild or absence of nausea in 72-77% following single exposure high-dose (8-10 Gy) radiotherapy to the upper abdomen. A subsequent double-blind, prospective, randomised trial compared ondansetron 8 mg t.d.s. with metoclopramide 10 mg t.d.s. in the prevention of emesis following single radiation doses of 8-10 Gy to the upper abdomen. On the day of radiotherapy, ondansetron achieved significantly greater control of vomiting and retching (P less than 0.001) and nausea (P = 0.001) than metoclopramide. An advantage for ondansetron was also seen on days 2 and 3 after irradiation, although this did not reach a statistically significant level. Only two patients, out of 154, in all the studies experienced side effects attributable to ondansetron: one developed headache and the other experienced headache and vertigo. These studies show that ondansetron is a safe drug, with activity in the prevention of radiation-induced emesis and significantly greater efficacy than metoclopramide in the control of nausea and vomiting following single exposure upper abdominal high-dose radiotherapy.
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PMID:Clinical studies with ondansetron in the control of radiation-induced emesis. 253 96

Although significant advances have been made in the treatment of malignant diseases, many agents cause nausea and vomiting severe enough to cause patients to be hospitalised or to refuse further treatment. Several classes of anti-emetics are currently used, but are only partially effective and are often associated with side effects such as extrapyramidal reactions. Ondansetron, a specific 5-HT3 antagonist, has been fully evaluated in the clinic, both as an intravenous and oral presentation, and in open studies in patients receiving non-cisplatin chemotherapy regimens it was highly effective in controlling acute and delayed emesis -- more than 90% of patients had a complete or major response to treatment. In three randomised, double-blind studies comparing ondansetron and metoclopramide, ondansetron was found to be superior in the control of both emesis and nausea. Ondansetron was also shown to be safe and well tolerated; in particular, no extrapyramidal reactions were reported.
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PMID:The role of ondansetron in the treatment of emesis induced by non-cisplatin-containing chemotherapy regimes. 253 97

Nausea and vomiting occur in all patients following high-dose cisplatin chemotherapy, unless an effective anti-emetic is administered. Early clinical studies therefore examined ondansetron treatment to establish an optimal dosing schedule for acute emesis. Pilot studies suggested that a daily dose of 32 mg ondansetron, given as a continuous intravenous infusion or intermittently on a mg/kg basis, gives optimum control of emesis, and was therefore selected for comparative studies. Efficacy was confirmed in two randomised, double-blind, crossover studies comparing ondansetron and metoclopramide. Ondansetron was superior to high-dose metoclopramide in controlling acute emesis and nausea, and there was a significant patient preference for ondansetron. These effects may be related to ondansetron's greater potency as a competitive 5-HT3 antagonist. In addition, ondansetron did not induce any extrapyramidal reactions, confirming the absence of any dopamine antagonist activity.
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PMID:Ondansetron in the prophylaxis of acute cisplatin-induced nausea and vomiting. 253 98

Two randomized, double-blind placebo-controlled ondansetron dose ranging studies in patients receiving high-dose cyclophosphamide (with or without doxorubicin) were completed in the US. These studies enable the pattern of emesis and nausea for 3 days following high-dose cyclophosphamide to be described and give some insight into the mechanisms of emesis which may be operating. Nausea and vomiting induced by cyclophosphamide-based chemotherapy has a long latency of onset (8-13 h) and continues for at least 3 days. These findings are of particular importance as many of these patients receive chemotherapy as outpatients and emphasize the need for appropriate anti-emetic prophylaxis for patients at home. Ondansetron was extremely effective over this time in the control of emesis and nausea. These results suggest that high-dose cyclophosphamide-induced emesis over days 1-3 is largely mediated via 5-hydroxytryptamine (5-HT) and 5-HT3 receptors.
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PMID:The pattern of emesis following high-dose cyclophosphamide and the anti-emetic efficacy of ondansetron. 754 Aug 92

We investigated the antiemetic efficacy and safety of intravenous ondansetron infusion in the BMT setting. We conducted prospective randomized comparison trials between ondansetron at 2 dose levels and metoclopramide (MCP) plus droperidol for the prevention of chemotherapy-induced nausea and vomiting in 2 patient populations scheduled to undergo BMT. One patient population (n = 30) received CY alone, the other population (n = 30) received combination chemotherapy of Bu and CY. The CY alone group received ondansetron for 3 days, and the Bu/CY group received ondansetron for 7 days. The primary endpoints were emesis control and nausea. Secondary endpoints included acute (headache, diarrhea and sedation) and delayed (engraftment and regimen-related) side-effects. In both trials, ondansetron provided better emesis control than did MCP plus droperidol during CY administration (P = 0.009, 3-day trial; P = 0.0022, 7-day trial). There was a wide interpatient variation in serum ondansetron levels, although group averages were proportional to the dose administered. Intrapatient day-to-day variation was 10-30% and did not change significantly with concurrent CY administration. Antiemetic efficacy did not correlate with ondansetron serum levels at the doses tested. Headache incidence was similar in all groups. Sedation was highest in the MCP plus droperidol group (P = 0.048, 3-day trial; P = 0.016, 7-day trial). No statistically significant differences in engraftment or regimen-related toxicities were observed between groups in either trial. Ondansetron appears to be a safe and efficacious antiemetic during conditioning for BMT.
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PMID:Antiemetic efficacy and pharmacokinetics of intravenous ondansetron infusion during chemotherapy conditioning for bone marrow transplant. 758 Nov 39

One hundred children with non-central nervous system malignancies received ondansetron at initiation of chemotherapy and every 8 hours for 5 days after cisplatin-containing therapy and for 3 days after other chemotherapy. Ondansetron was administered orally except with the intravenous chemotherapy. For the chemotherapy days, 72 of 93 children (76%) had complete or major control of vomiting on their worst day, 25% with cisplatin-containing protocols, 60% with ifosfamide-containing protocols, and 82% with other protocols. For the overall period, 71 of 93 children (76%) reported complete or major control of vomiting on the worst day, 14% with cisplatin, 60% with ifosfamide, and 83% with other chemotherapy. All had mild or no nausea. Of the 355 chemotherapy days, 228 children (64%) were emesis free, 40% with cisplatin, 60% with ifosfamide, and 68% with other regimens. Of the overall period (541 days), 393 days were emesis free, 45% with cisplatin, 71% with ifosfamide, and 86% with other regimes. Sixty-nine patients were not hospitalized, and oral ondansetron was given when chemotherapy was completed. Of the 241 ambulatory chemotherapy days, 178 (74%) were emesis free. No significant toxicity was encountered. Oral ondansetron reduced hospitalization without reducing antiemetic efficiency in children.
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PMID:Oral ondansetron: an effective ambulatory complement to intravenous ondansetron in the control of chemotherapy-induced nausea and vomiting in children. 770 44

The purpose of this study was to determine whether preloading administration of ondansetron given 12.5 h before cisplatin therapy, every 6 h, is better in controlling acute cisplatin-induced emesis than a standard dose every 8 h. All patients had previously received three cycles of CDDP-based chemotherapy in a dose of 100 mg/m2. Ondansetron was given according to two schedules: in group A (40 patients) at a dose of 8 mg in 100 ml normal saline over 10 min by intravenous infusion before the infusion of CDDP continued with 1 tablet of 8 mg after 8 and 16 h; in group B (40 patients) it was administered in six intravenous doses (every 6 h) starting 12.5 h before cisplatin administration. During the following 3 days, patients from both groups continued with tablets of 8 mg orally, every 8 h in group A and every 6 h in group B. The only difference in terms of the antiemetic response noticed between the two groups was in the number of patients that presented with nausea, which was increased in group A (32) in comparison to group B (25; p < 0.022). No difference was found in the number of vomiting episodes, retches or control of emesis, during the 3-day evaluation period after cisplatin infusion, and in secondary side effects. In conclusion the total dose of 24 mg ondansetron during the acute phase of emesis is as effective as preloading and increasing the total dose to 32 mg.
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PMID:Efficacy of ondansetron treatment with different timing schedules: a randomized double-blind study. 777 46

Ondansetron in the prophylaxis of Cisplatin-induced emesis and nausea. The 5-HT3 antagonist ondansetron clearly offers a new approach to the control of Cisplatin-induced emesis and has been evaluated in Thailand. To evaluate anti-emetic efficacy of ondansetron in the prevention of nausea and vomiting induced by Cisplatin containing cancer chemotherapy regimen, we carried out an open multicentre study from January 1991 to December 1992. In this study, patients receiving Cisplatin based chemotherapy received ondansetron 32 mg as a single intravenous dose over 15 minutes prior to the administration of Cisplatin. This was followed by oral ondansetron 8 mg three times a day, preferably one hour before each meal for 5 days. All patients were chemotherapy naive in-patients and were at least 18 years or older with Karnofsky performance status of at least 60 per cent. The number of emetic episodes, nausea and food intake were recorded during the 24 hours following Cisplatin administration. A total of 103 patients were recruited with 84 (81.6%) evaluable patients (48 men and 36 women) scheduled to receive cisplatin chemotherapy at dose 60 mg/m2 or more (60-100 mg/m2), either as single agent or combination therapy. Complete response (complete control of emesis) was achieved in 60 per cent; major response (1-2 emetic episodes) was 13 per cent; minor response (3-5 emetic episodes) was 13 per cent; and failure (5+ emetic episodes) was 10 per cent. Side effects were very mild and not significant. We conclude that ondansetron is efficacious in protecting patients from Cisplatin induced emesis and nausea.
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PMID:Ondansetron: prevention of nausea & vomiting in cisplatin based chemotherapy. 784 94

The purpose of our study was to evaluate different schedules of ondansetron administration in cisplatin-induced emesis. All patients had previously received 2 cycles of CDDP-based chemotherapy in a dose of 100 mg/m2. Ondansetron was given by two schedules. Group A (45 patients) received a dose of 1 ampoule of 8 mg in 100 ml normal saline in a 10-min intravenous infusion before the infusion of CDDP; this was continued by 1 tablet of 8 mg in the afternoon and 1 before sleeping on the first day. For the next 3 days, the patients received 3 tablets of 8 mg daily. In group B (45 patients) the same doses were used at the same time and by the same route as in group A, except on the first day when all the dosages were intravenous. Nausea persisted for a longer time (A = 177 +/- 271 min, B = 78 +/- 83 min, p < 0.022), and it was intenser in group A (grade 0, p < 0.036, grade 1, p < 0.050) in comparison with group B. More patients of group B achieved complete (p < 0.015) and minor (p < 0.050) control of emesis, on the other hand group A presented an increased number with major (p < 0.015) and failure (p < 0.069) of control of emesis. There was no difference in nausea and vomiting for the next 3 days nor any difference in secondary side effects. We conclude that the intravenous administration schedule has shown superior antiemetic efficacy in patients who received cisplatin during the first 24 h.
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PMID:Comparison of different schedules of ondansetron (GR 38032F) administration during cisplatin-based chemotherapy: a randomized trial. 787 25

Ondansetron, a selective 5-HT3 receptor antagonist, has recently been shown, in a dose of 8 mg, to be superior to 1.25 mg droperidol in preventing postoperative vomiting. There are indications that a dose of 4 mg of ondansetron may be just as effective in reducing postoperative nausea and vomiting as a dose of 8 mg. The aim of this study was to evaluate the efficacy and the adverse effects of 4 mg ondansetron in the prevention of postoperative nausea and vomiting compared to droperidol in patients undergoing surgery with inhalation anaesthesia supplemented with alfentanil. METHODS. Following institutional approval, 40 ASA physical status I and II women scheduled for minor gynaecological surgery gave informed consent to participate in this randomized, double-blind comparative study. Five minutes before induction of general anaesthesia, 20 patients received a single intravenous (i.v.) dose of 4 mg of ondansetron and the remaining 20 received 1.25 mg droperidol i.v. Anaesthesia was induced with 2.1-4 mg/kg of thiopental and 0.1 mg of alfentanil i.v. and maintained with 65% nitrous oxide and 1.5%-3% enflurane in oxygen. On pain stimuli another 0.2-0.4 mg of alfentanil was given. Total effective antiemetic response was defined as the absence of nausea and vomiting for 24 h postoperatively. The incidence of nausea, vomiting and the number of patients showing total antiemetic response as well as the incidence of adverse effects were compared with the chi 2 test and P < 0.05 was considered significant. RESULTS. Patients were similar with respect to age, height, body weight and total anaesthetic agents received. Duration of anaesthesia and the time until awakening was not significantly different among groups. Postoperatively 7 out of 20 patients given 4 mg of ondansetron and 3 out of 20 patients with droperidol vomited (n.s.). The incidence of nausea was 11 out of 20 in the ondansetron group, and 4 out of 20 in the droperidol group (P < 0.05). Sixteen patients in the droperidol group and 8 patients in the ondansetron group showed a total effective antiemetic response (P < 0.05). Postoperative sedation and well-being scores did not differ significantly among groups. CONCLUSION. Our results show that for the prevention of postoperative nausea and vomiting 4 mg of Ondansetron was inferior to 1.25 mg of droperidol. The drugs were given intravenously prior to general anaesthesia for minor gynaecological surgery with nitrous oxide and enflurane in oxygen supplemented with small boluses of alfentanil.
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PMID:[Ondansetron as prophylaxis for postoperative nausea and vomiting. A prospective randomized double-blind comparative study with droperidol]. 797 72


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