Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0042963 (vomiting)
 31,883 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

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 micrograms/kg (Group A), ondansetron 75 micrograms/kg (Group B), or droperidol 75 micrograms/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 micrograms/kg was as effective as 150 micrograms/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.
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PMID:A double-blind randomized prospective study comparing ondansetron with droperidol in the prevention of emesis following strabismus surgery. 748 33

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

Ondansetron is a potent and highly selective serotonin 5-HT3-receptor antagonist which has demonstrated important antiemetic activity and good tolerability in the prevention of chemotherapy-induced nausea and vomiting. Ondansetron is completely and rapidly absorbed from the gastrointestinal tract after oral administration, and does not accumulate with repeated oral administration. Owing to hepatic first-pass metabolism, its bioavailability is only about 60% compared with ondansetron administered by infusion over 15 minutes. Bioavailability is slightly increased when administered after a standard meal, and is not influenced by coadministration of antacids; a slightly enhanced bioavailability has been observed in patients with cancer. Since the time to reach peak concentration is 0.5 to 2 hours after oral ingestion, the drug should be administered at least 30 minutes before chemotherapy. Possible alternative ways of administration of ondansetron include intramuscular, subcutaneous and rectal administration, and oral controlled-release formulations. Ondansetron is widely distributed (volume of distribution approximately 160L) and binds moderately (70 to 76%) to plasma proteins; the elimination half-life averages approximately 3.8 +/- 1 hours. Clearance occurs by hepatic metabolism (95%) rather than renal excretion. Metabolites do not play a role in the activity of the drug, and there is no evidence of genetic polymorphic metabolism. Although aging is associated with decreased clearance and increased bioavailability, dosage adjustments are not required for the elderly, and may be necessary only in patients with severe hepatic impairment. Chemotherapeutic agents do not seem to modify the pharmacokinetics of ondansetron. There remains the question of whether control of emesis is related to systemic availability of ondansetron and, in consequence, the optimal dose and schedule of ondansetron is still to be identified with certainty.
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PMID:Ondansetron clinical pharmacokinetics. 758 4

The antiemetic effect of ondansetron (supplied by Qilu Pharmaceutical Company) in patients receiving non-cisplatin chemotherapy (containing CTX and/or ADM) was studied in a multiple centre, randomized cross-over trial. The patients who had vomiting in the first turn of chemotherapy entered the trial. The patients received randomly ondansetron or control drugs-metoclopramide or Zofran (Glaxo) in the second turn of chemotherapy. In the third, the patients were cross-over to use the other antiemetic drug. A total of 155 patients were enrolled into the study. The results showed, the effective control rate (0-2 emetic episodes) on the first day were 87.7% of patients treated with ondansetron and 61.6% treated with metoclopramide. The mean frequency of vomiting was 0.8 times in ondansetron and 2.7 times in metoclopramide (P < 0.01). Ondansetron was superior to metoclopramide for the control of emesis. The antiemetic effects of ondansetron (Qilu) and Zofran (Glaxo) were very similar. The side-effects of ondansetron were mild.
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PMID:[The role of ondansetron (Qilu) in the prevention of non-cisplatin-induced vomiting--a randomized clinical trial]. 758

Ondansetron has had a major impact on the prevention of emesis in patients receiving chemotherapy. However, the high cost and potential for inappropriate prescribing of this agent warranted a closer examination of its utilization. Hospital guidelines regarding the use of ondansetron were prepared by the Pharmacy and Therapeutics Committee and approved by the Medical Advisory Committee. The guidelines were then distributed to all physicians. Physicians were randomized into an intervention or non-intervention group. A prospective drug use evaluation was then conducted for a 10-week period where pharmacists monitored ondansetron prescribing and compared each order against hospital guidelines. For orders deemed inappropriate, only the intervention-group physicians were contacted for therapy modification. The control of nausea and vomiting was then assessed for all patients 24 h and 72 h after chemotherapy via a simple patient questionnaire. There were no significant differences with respect to the control of nausea and vomiting between patients who received ondansetron according to guidelines and those who did not. A total of 76% (48/63) of the prescriptions met hospital guidelines in the intervention group compared to 51.6% (33/64) in the control (P = 0.007). During the study period, physicians in the intervention group prescribed $Can 757 worth of ondansetron inappropriately compared to $1814 in the control. Drug use evaluation with pharmacist intervention was an effective method of controlling unnecessary hospital costs and contributed towards the appropriate use of ondansetron without compromising patient care.
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PMID:A randomized trial of the effects of pharmacist intervention on the cost of antiemetic therapy with ondansetron. 765 79

Ondansetron is a selective 5-HT3 receptor antagonist which has previously been reported in the Journal to be a promising new agent for use as prophylaxis against nausea and vomiting caused by chemotherapy and radiotherapy. Since the publication of this original review, further studies have been published that show ondansetron to be an effective antiemetic agent in patients receiving chemotherapy and radiotherapy. Several studies have shown ondansetron to be a more effective antiemetic agent than high-dose metoclopramide in patients with emesis induced by high- and low-dose cisplatin treatment, and noncisplatin chemotherapy-induced emesis. The drug as mono-therapy does not appear to offer any advantage over alternative therapies against delayed high-dose cisplatin-induced nausea and vomiting; however, extremely limited data suggest that ondansetron plus dexamethasone may be useful in this indication. Trials have shown combination therapy with ondansetron and dexamethasone to be significantly more effective than both ondansetron monotherapy and a standard antiemetic regimen comprising metoclopramide, dexamethasone and diphenhydramine against acute high-dose cisplatin-induced emesis. Results from a number of small scale trials suggest that ondansetron may be an effective treatment for chemotherapy-induced emesis refractory to conventional antiemetic therapy. Ondansetron also appears to be more effective against refractory emesis induced by noncisplatin chemotherapy than that induced by cisplatin chemotherapy. Several trials have shown ondansetron to be more effective than placebo as prophylaxis against postoperative nausea and vomiting; a further trial has shown single-dose ondansetron to be significantly more effective than single-dose droperidol or metoclopramide in this indication. In addition, several trials have shown ondansetron to be more effective than placebo as treatment for nausea and vomiting that has commenced postoperatively. The overall incidence of adverse events in ondansetron recipients during chemotherapy-induced emesis studies was 36%. Headache and constipation are the most common adverse events during ondansetron therapy. Thus, recent data affirms the efficacy of ondansetron in the treatment of acute chemotherapy-induced nausea and vomiting and shows it to be especially efficacious when combined with dexamethasone. It appears that the drug will also have a substantial role in the prophylaxis and treatment of postoperative nausea and vomiting.
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PMID:Ondansetron. An update of its therapeutic use in chemotherapy-induced and postoperative nausea and vomiting. 769


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