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)

We assessed the antiemetic efficacy and safety of three different oral doses of ondansetron (GR 38032F), a novel serotonin type-3 receptor antagonist, in three consecutive series of 20 breast cancer patients receiving cyclophosphamide-doxorubicin-based chemotherapy for the first time. Patients received oral doses of 8 mg, 4 mg, or 1 mg of ondansetron three times daily for 2 days, with the first dose given 30 minutes before the cyclophosphamide infusion. We then evaluated the efficacy of a conventional antiemetic regimen of intravenous lorazepam, metoclopramide, and diphenhydramine given before chemotherapy and 10 mg prochlorperazine given orally twice on study day 1 and three times on study day 2 in a fourth series of 20 patients with comparable characteristics. The number of emetic episodes, assessment of nausea and appetite, and adverse events were recorded throughout the 2-day study period. Pretreatment and posttreatment clinical laboratory data were also collected. No emesis was observed during the 2-day study period in 17 (85%), 13 (65%), and 11 (55%) patients treated with 8-mg, 4-mg, and 1-mg ondansetron doses, respectively, and in seven (35%) patients who received conventional therapy. The incidence and intensity of nausea were lower with increasing doses of ondansetron and were lower than in the conventional group. Ondansetron-related side effects were generally mild and reversible and did not appear to increase in a dose-dependent manner. These effects included headache, stomach cramps, diarrhea, fatigue, and elevated serum transaminase concentrations. One patient who received three 1 mg doses of ondansetron experienced tremors and muscle twitching. Oral ondansetron is an effective and safe antiemetic for patients receiving noncisplatin cyclophosphamide-doxorubicin-based chemotherapy, and its antiemetic activity appears to be dose-related.
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PMID:Evaluation of three oral dosages of ondansetron in the prevention of nausea and emesis associated with cyclophosphamide-doxorubicin chemotherapy. 182 99

The efficacy of the serotonin antagonist ondansetron (GR38032F, Glaxo) was evaluated in the prevention of nausea and vomiting induced by combinations containing cyclophosphamide (CTX) greater than or equal to 600 mg/m2 IV day. At their first treatment course, 55 patients (10 males, 45 females) median age 55 years (range 31-76) were given ondansetron 8 mg orally tds for a minimum of 3 to a maximum of 5 days. 54 patients were evaluable. Complete and major control of acute (day 1) emesis was observed in 94.5% of patients and acute nausea was graded as absent or mild in 83.3% of cases. Complete and major control of emesis improved on subsequent study days from 96.1% on study day 2 to 100% on study day 5. Side effects were mild. Ondansetron is a safe and effective antiemetic drug.
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PMID:Oral ondansetron (GR38032F) for the control of acute and delayed cyclophosphamide-induced emesis. 182 2

Ondansetron (OND) is a new 5-HT3 receptor antagonist that give complete protection from emesis/nausea in approximately 50% of cisplatin (CDDP)-treated patients. To evaluate if dexamethasone (DEX) added to OND increases antiemetic efficacy, we carried out a double-blind randomized crossover study to compare the antiemetic activity of OND with OND plus DEX. One hundred two chemotherapy-naive patients (44 women and 58 men) scheduled to receive CDDP chemotherapy at doses greater than or equal to 50 mg/m2 entered the study. Eighty-nine patients completed both cycles with the following results: complete protection from emesis/nausea was obtained in 57/59 patients (64.0%/66.3%) with OND and in 81/79 (91.0%/88.8%) with OND plus DEX (P = .0005/P = .0021). At the end of the study, 53% of the patients expressed a treatment preference, and of these, 74% chose OND plus DEX compared with 26% who preferred OND alone, a statistically significant difference (P less than .003). Side effects were very mild and not significantly different between the two treatments. We conclude that OND plus DEX is more efficacious than OND in protecting patients from CDDP-induced emesis and nausea.
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PMID:Prevention of cisplatin-induced emesis: a double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone. 182 57

Ondansetron is a selective 5-HT3 antagonist with significant antiemetic properties in patients receiving cytotoxic chemotherapy. Patients who had suffered severe vomiting on carboplatin alone (23 patients with ovarian carcinoma) or in combination (two patients with testicular cancer) despite intensive antiemetic regimens were treated with ondansetron, given as 8 mg immediately prior to carboplatin followed by 8 mg orally, 8 hourly for 5 days. Twenty-five patients received 58 courses of ondansetron. In the first 24 h after the first course of chemotherapy with ondansetron, 17 patients (68%) experienced no vomiting, five patients (20%) had almost complete control and the other three patients had partial control. During the subsequent 4 days slightly lesser control was achieved. Nausea was similarly controlled in most patients. Twenty-two patients stated a preference for ondansetron with future chemotherapy. Fourteen patients received additional chemotherapy with ondansetron and in only three patients did the efficacy of therapy lessen. Toxicity was mild and transient with headache and constipation predominant. No extrapyramidal reaction was seen. Sedation was absent. Ondansetron is highly effective in refractory vomiting associated with carboplatin chemotherapy. It may be particularly beneficial when an extrapyramidal reaction has occurred on previous antiemetics and when sedation is unacceptable.
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PMID:Reduction of carboplatin induced emesis by ondansetron. 182 54

Postoperative nausea and vomiting are common after recovery from general anesthesia. The antiemetic effect and safety of ondansetron, a selective serotonin type 3 (5-HT3) receptor antagonist, was determined in 36 patients suffering from nausea or vomiting during recovery from intravenous anesthesia by giving either a single intravenous dose of ondansetron (8 mg, n = 18) or placebo (n = 18) over 2-5 min in a randomized, double-blind manner. A "rescue" antiemetic was provided in case of continued vomiting or at the patient's request. Antiemetic efficacy was defined as no request for rescue antiemetic and/or no vomiting episode during the next 4 h. There was no significant difference in the demographic data between the groups. Administration of ondansetron or placebo had no significant effect on vital signs. Ondansetron was an effective antiemetic in 78% (14/18) and placebo was effective in 28% (5/18) of the patients. Laboratory studies 24 h later showed no signs of hematologic, hepatic, or renal alterations. Ondansetron at a dose of 8 mg administered intravenously over 2-5 min appears to be a safe and effective antiemetic for the treatment of nausea and/or vomiting after intravenous anesthesia.
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PMID:Treatment of postoperative nausea and vomiting with ondansetron: a randomized, double-blind comparison with placebo. 153 41

The safety and efficacy of ondansetron were evaluated for the treatment of postoperative nausea and vomiting after laparoscopic surgical procedures. Seventy-one healthy, consenting outpatients were randomly assigned to one of two treatment groups according to a double-blind, placebo-controlled protocol. A standardized anesthetic technique consisting of alfentanil-thiopental-succinylcholine for induction and alfentanil-nitrous oxide-succinylcholine for maintenance of anesthesia was used. Patients in whom postoperative nausea and/or vomiting developed and persisted for greater than or equal to 10 min received equivolemic intravenous injections of either ondansetron (8 mg) or saline (placebo) over a 2-5 min period. Ondansetron significantly decreased the posttreatment nausea scores (vs placebo) without increasing sedation or producing changes in cardiorespiratory parameters. In the placebo-treated group, 92% of the patients experienced subsequent episodes of vomiting in the postanesthesia care unit compared with 51% of the patients in the ondansetron group. Finally, only 43% of the ondansetron-treated patients required a "rescue" antiemetic compared with 86% in the placebo group. Thus, ondansetron (8 mg IV) was associated with a decreased incidence of nausea and vomiting after outpatient laparoscopic procedures.
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PMID:Antiemetic efficacy of ondansetron after outpatient laparoscopy. 153 41

Ondansetron as a single agent has been shown to be superior to metoclopramide in the control of acute nausea and vomiting induced by high-dose cisplatin, complete or major control (0-2 emetic episodes) being achieved in 65-75% of patients. In an attempt to further improve efficacy in this group of patients, a randomised, double-blind, crossover study was carried out comparing ondansetron with ondansetron plus dexamethasone. Ondansetron was given as three intravenous doses (0.15 mg/kg) 2-hourly and dexamethasone as a single intravenous dose of 20 mg prior to cisplatin (median 70 mg/m2, range 50-120 mg/m2). Complete control of emesis was achieved in 91% of patients receiving the combination of ondansetron plus dexamethasone and in 64% of patients receiving ondansetron alone (P less than 0.001). Nausea was absent in 89% of patients receiving the combination and in 66% of patients receiving ondansetron alone (P less than 0.0025). Both treatments were well tolerated. The addition of a single dose of dexamethasone to ondansetron significantly improves the control of emesis and nausea compared to ondansetron monotherapy in patients receiving high-dose cisplatin.
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PMID:Ondansetron plus dexamethasone: an effective combination in high-dose cisplatin therapy. The Italian Oncology Group for Clinical Research. 183 28

The efficacy and tolerability of twice-daily oral ondansetron treatment, after a single i.v. dose prechemotherapy, was compared with the established three times a day oral supplement regimen for the prophylaxis of nausea and vomiting induced by cyclophosphamide (greater than or equal to 500 mg/m2) in combination with doxorubicin (greater than or equal to 40 mg/m2) or epirubicin (greater than or equal to 40 mg/m2). Additional treatment with ondansetron twice daily or three times daily was equally effective in controlling emesis and nausea. Supplementary twice-daily oral treatment prevented emesis in 73% of patients in the first 24 h and in 65% of patients over 3 days. Both dose schedules were safe and well tolerated. Ondansetron given i.v. before chemotherapy followed by twice-daily (12-hourly) oral dosing has good efficacy in the control of emesis in oncology outpatients.
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PMID:Oral treatment with ondansetron in an outpatient setting. 183 30

Ondansetron was compared with metoclopramide for antiemetic efficacy in a randomised double-blind trial in 122 patients with advanced breast cancer. All patients were treated with epirubicin (greater than 50 mg/m2) and cyclophosphamide (greater than 500 mg/m2). 50 patients receiving ondansetron and 60 with metoclopramide were considered evaluable. Ondansetron was at least as effective as metoclopramide in the control of vomiting and nausea. The percentage of patients with complete plus major control was 72% (59-85%) vs. 61% (48-74%) on day 1 (P = 0.230) and 79% (67-91%) vs. 66% (53-78%) on days 2-3 after chemotherapy (P = 0.122). Over the 3-day study period, nausea was absent or mild in 60% of the patients treated with ondansetron, compared to 45% given metoclopramide (P = 0.064). No major drug-related side-effects were reported. 1 patient receiving ondansetron experienced gastrointestinal disturbance and headache. Episodes of diarrhoea, fever, hyperkinetic syndrome, fatigue, restlessness and migraine with vomiting were reported by 5 patients treated with metoclopramide. None of the changes in the biochemical or haematological parameters was attributed to the antiemetic treatments.
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PMID:Double-blind randomised trial of the antiemetic efficacy and safety of ondansetron and metoclopramide in advanced breast cancer patients treated with epirubicin and cyclophosphamide. 183 24

The efficacy of the serotonin antagonist ondansetron (GR 38032F) was evaluated in the prevention of nausea and vomiting induced by CMF chemotherapy in 29 breast cancer patients. At their first treatment course of CMF, all given IV on day 1 q 21 days, patients were given oral antiemetic treatment as follows: ondansetron 8 mg, 2 h prior to CMF, repeated after 5 and 10 h the day of chemotherapy and then 8 mg tds for a minimum of 3 days to a maximum of 5 days following chemotherapy. At first course of CMF, complete protection from emesis and nausea was observed in 86.2% and 62% of patients, respectively. At subsequent CMF courses with ondansetron, complete control of emesis was observed in 80% of patients. Side effects were mild and no dystonic reactions were observed. Ondansetron represents an effective, safe, and easily administered outpatient regimen. The addition of a corticosteroid to ondansetron could further improve control of CMF-induced emesis.
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PMID:Oral ondansetron (GR 38032F) for the control of CMF-induced emesis in the outpatient. 183 46


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