A retrospective chart review of the antiemetic effectiveness of risperidone in refractory opioid-induced nausea and vomiting in advanced cancer patients

Nausea and vomiting are distressing symptoms in advanced cancer patients. The causes of nausea and vomiting are multifactorial. Among the causes is opioid therapy, the mainstay of cancer pain management. When nausea or other opioid side effects occur, it may hamper pain management and undermine the quality of life of cancer patients. Risperidone exerts an antiemetic effect in animals, but there has been no clinical report on its antiemetic activity. We conducted a retrospective chart review to examine whether risperidone is useful for opioid-induced nausea and vomiting in advanced cancer patients (n=20). Risperidone was given as doses of 1mg once a day. Complete response was observed in 50% of patients (10/20) for nausea and 64% (7/11) for vomiting. Sedation (n=2) was documented as an adverse effect. This observation suggests that risperidone can be an effective antiemetic drug in the treatment of refractory opioid-induced nausea and vomiting in advanced cancer patients.     

A double-blind, randomised, parallel group, multinational, multicentre study comparing a single dose of ondansetron 24 mg p.o. with placebo and metoclopramide 10 mg t.d.s. p.o. in the treatment of opioid-induced nausea and emesis in cancer patients

Nausea and emesis are common side effects of opioid drugs administered for pain relief in cancer patients. The aim of this study was to compare the anti-emetic efficacy and safety of ondansetron, placebo and metoclopramide in the treatment of opioid-induced nausea and emesis (OIE) in cancer patients. This was a multinational, multicentre, double-blind, parallel group study in which cancer patients who were receiving a full opioid agonist for cancer pain were randomised to receive one of oral ondansetron 24 mg once daily, metoclopramide 10 mg three times daily, or placebo. Study medication was started only if the patient experienced nausea and/or emesis following opioid administration. Efficacy and safety assessments were made over a study period of 24 h from the time of the first dose of anti-emetics/placebo. The study was terminated prematurely because of the difficulties in recruiting patients satisfying the stringent entry criteria. Ninety-two patients were included in the intent-to-treat population: 30 patients received placebo, 29 patients ondansetron and 33 patients metoclopramide. There was no statistically significant difference between the groups in the proportion achieving complete control of emesis (33% of patients on placebo, 48% on ondansetron and 52% on metoclopramide) or complete control of nausea (23% of patients on placebo, 17% on ondansetron and 36% on metoclopramide). Rescue anti-emetics were required in 8 of 33 patients on metoclopramide, 4 of 29 on ondansetron, and 3 of 30 on placebo. The incidence of adverse events was very low and similar in all treatment groups. Neither ondansetron 24 mg once daily nor metoclopromide 10 mg t.d.s. given orally was significantly more effective than placebo in the control of OIE in cancer patients.     

A multicenter, double-blind, randomized comparison of oral ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with highly emetogenic chemotherapy

The objectives of this study were to compare the efficacy and safety of orally administered ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with high-dose cisplatin-based chemotherapy (cisplatin > or = 50 mg/m2). This was a randomized, parallel-group, double-blind study conducted in North America. It was planned that all patients would receive one of the following orally administered ondansetron treatments 30 min before starting cisplatin dosing (administered over < or = 3 h): 8 mg b.i.d. with 8 h between doses (124 patients), 24 mg q.d. (116 patients), and 32 mg q.d. (117 patients). Use of prophylactic corticosteroids was not permitted. During the 24-h study period, the highest complete response rate (no emesis, rescue antiemetic therapy, or withdrawal) occurred in patients who received ondansetron 24 mg q.d.: 76/115 or 66%, as against 68/124 (55%) after ondansetron 8 mg b.i.d. and 64/117 (55%) after ondansetron 32 mg q.d. Complete control of nausea (no nausea, no rescue, no withdrawal) occurred in more patients in the ondansetron 24 mg q.d. group (64/114, 56%) than in the ondansetron 8 mg b.i.d. group (43/121, 36%) or in the ondansetron 32 mg group (55/117, 50%). These results demonstrate that following highly emetogenic cisplatin-based chemotherapy (> or =2 50 mg/m2), oral ondansetron 24 mg q.d. is more effective than 8 mg b.i.d. for overall control of nausea, and at least as effective if not more effective in the control of acute vomiting than 8 mg b.i.d. or 32 mg q.d. Ondansetron 24 mg q.d. was well tolerated, and no new or unexpected adverse events were identified.     

No more than necessary: safety and efficacy of low-dose promethazine

BACKGROUND: Limitations in antiemetic options have resulted in increased use of intravenous promethazine. However, this drug has significant sedative effects with its standard dosage of 25 mg, especially when used in conjunction with narcotic analgesics. While studies have revealed the bioavailability of enteric promethazine to be 25%, current dosing references suggest identical dosing regardless of the route of administration. OBJECTIVE: To compare the antiemetic efficacy and sedative effects of low-dose intravenous promethazine (6.25 or 12.5 mg) with intravenous ondansetron 4 mg. METHODS: We assessed inpatients with noncritical conditions at Anne Arundel Medical Center who were treated for nausea or vomiting from any cause except chemotherapy or pregnancy. Forty-six patients received low-dose promethazine and 41 received ondansetron. Statistical analysis was carried out for significant differences in efficacy and sedation. RESULTS: For patients who received intravenous promethazine 6.25 or 12.5 mg, nausea and vomiting were relieved at one hour in 74% and 68%, respectively, compared with 59% for intravenous ondansetron 4 mg. Results at 3 hours were 67% and 80% for promethazine and 71% for ondansetron. Median sedation scores at one hour were equal at 3 for promethazine and ondansetron (4 = fully awake); at 3 hours, the median scores were 4 and 3.5, respectively. There were no statistically significant differences among any of these results. CONCLUSIONS: Low-dose (6.25 mg) intravenous promethazine relieves nausea and vomiting as effectively as intravenous ondansetron 4 mg.     

Ondansetron is effective in decreasing postoperative nausea and vomiting.

The efficacy of ondansetron, a selective 5-HT3 receptor antagonist, in preventing postoperative nausea and vomiting in surgical patients was studied. Fifty women were randomized in a double-blind manner to receive either two 8 mg doses of intravenous ondansetron or two doses of placebo vehicle: the first given just before general anesthesia induction and the second 8 hours later. During the first 24 postoperative hours, the number of emetic episodes was recorded and the subjects rated their nausea on a scale from 0 to 10. Ondansetron-treated subjects had fewer emetic episodes (p less than 0.001) and lower subjective nausea scores (p less than 0.001). The number of complete responders (no emetic episodes and no rescue therapy) was 1 of 24 (4%) and 15 of 26 (58%) in the placebo and ondansetron groups, respectively (p less than 0.001). Ondansetron is clearly more effective than placebo in the prophylaxis of postoperative nausea and vomiting. The adverse event profile for ondansetron was similar to that of placebo.     

Alvimopan: an oral, peripherally acting, mu-opioid receptor antagonist for the treatment of opioid-induced bowel dysfunction--a 21-day treatment-randomized clinical trial.

Alvimopan has been shown to reverse the inhibitory effect of opioids on gastrointestinal transit without affecting analgesia. We evaluated oral alvimopan, 0.5 or 1 mg, versus placebo, once daily for 21 days, in 168 patients with opioid-induced bowel dysfunction (OBD) who were receiving chronic opioid therapy (minimum, 1 month) for nonmalignant pain (n = 148) or opioid dependence (n = 20). The primary outcome was the proportion of patients having at least one bowel movement (BM) within 8 hours of study drug on each day during the 21-day treatment period. Averaged over the 21-day treatment period, 54%, 43%, and 29% of patients had a BM within 8 hours after alvimopan 1 mg, 0.5 mg, or placebo, respectively (P < .001). Secondary outcomes of median times to first BM were 3, 7, and 21 hours after initial doses of 1 mg, 0.5 mg, and placebo, respectively (P < .001; 1 mg vs placebo). Weekly BMs and overall patient satisfaction were increased after the 1-mg dose (P < .001 at weeks 1 and 2 vs placebo, and P = .046, respectively). Treatment-emergent adverse events were primarily bowel-related, occurred during the first week of treatment, and were of mild to moderate severity. Alvimopan was generally well tolerated and did not antagonize opioid analgesia. Patients treated with chronic opioid therapy often experience opioid-induced bowel dysfunction as a result of undesirable effects on peripheral opioid receptors located in the gastrointestinal tract. Alvimopan, a novel peripheral opioid mu-receptor antagonist, has demonstrated significant efficacy for the management of opioid-induced bowel dysfunction without compromise of centrally mediated opioid-induced analgesia.     

Cisplatin-related hiccups: male predominance, induction by dexamethasone, and protection against nausea and vomiting

Dexamethasone is likely to play a role in the etiology of hiccups in patients receiving cisplatin-based regimens. Two hundred seventy-seven patients received three doses of ondansetron 8mg intravenously (IV) at 4hour intervals plus dexamethasone 20mg IV from the start of chemotherapy, followed by dexamethasone 5mg IV every 12hours, until chemotherapy was complete. Hiccups were observed in 114 (41.2%) patients, of whom 97.4% were men. Nausea and vomiting showed inverse correlations with hiccups (P < 0.0001 and P = 0.001, respectively). In 73 patients who experienced hiccups but lacked nausea/vomiting (H+N/V-), we discontinued dexamethasone in subsequent cycles. Sixty-six patients (90.4%) ceased hiccuping, but complete protection rates of nausea and vomiting decreased to 63% and 74%, respectively. For patients who experienced both hiccups and nausea/vomiting, the onset of nausea/vomiting usually was delayed to Day 3 or 4 and began after the cessation of hiccups. We conclude that cisplatin-related hiccups are predominant in males, dexamethasone-induced, and associated with protection against nausea/vomiting.     

Dexamethasone in addition to metoclopramide for chronic nausea in patients with advanced cancer: a randomized controlled trial

Chronic nausea occurs in most patients with advanced cancer. This study was done to assess the antiemetic effects of dexamethasone in patients with chronic nausea refractory to metoclopramide. Secondary outcomes included appetite, fatigue, and pain. Fifty-one patients who had nausea (> or = 3/10 on a 0-10 scale) for > or = 2 weeks despite 48 hours of oral metoclopramide therapy (40-60 mg/day) were enrolled. Patients received 20 mg/day dexamethasone (DM) orally (n = 25) or placebo (n = 26) for severe nausea in addition to metoclopramide (60 mg/day orally). At baseline the mean nausea intensity ratings in the DM and placebo groups were 8.0 and 7.4. At Day 8 they were 2.1 and 2.0, respectively. At Day 3 and Day 8, the mean difference in nausea intensity for the DM and placebo groups was 4.5 and 2.9 (P = 0.16) and 5.9 and 5.7 (P = 0.85), respectively. Improvement in appetite and fatigue were observed on Day 3 and Day 8 in both groups as compared with the baseline. Pain, vomiting, well-being, and quality of life remained unchanged in both groups at both times. We conclude that DM was not superior to placebo in the management of chronic nausea in our patients with advanced cancer.     

The search for cost-effective prevention of postoperative nausea and vomiting in the child undergoing reconstructive burn surgery: ondansetron versus dimenhydrinate.

Postoperative nausea and vomiting (PONV) is a common and unpleasant problem for children with burns who are undergoing reconstructive burn surgery. Ondansetron and dimenhydrinate have been found to be effective for the prevention of PONV in other patient populations, but they have not been directly compared in the pediatric population. A prospective, randomized, double-blind, placebo-controlled comparison of ondansetron and dimenhydrinate was performed. One hundred patients with a mean age of 11.8 years who were undergoing reconstructive burn surgery with general anesthesia were randomly assigned to receive either a placebo, 0.1 mg/kg of ondansetron, or 0.5 mg/kg of dimenhydrinate. The 3 groups were well matched for all demographic and procedural variables. The study drugs were given twice, first at the end of surgery and again 4 hours later, to ensure adequate blood levels during the 8-hour study period. Postoperatively, on the basis of the presence and amount of PONV experienced, all patients were assigned a PONV score by a blinded investigator. Statistically significant reductions in the incidence of PONV in the patients who received ondansetron or dimenhydrinate were found, as compared with the results of patients who received placebo. Postoperative vomiting was reduced from 61% in the placebo group to 29% and 40% in the ondansetron and dimenhydrinate groups, respectively, and PONV was similarly reduced from 69% to 47% and 40%, respectively. The differences between ondansetron and dimenhydrinate were not significant. The average cost to our pharmacy for the prescribed dose of ondansetron was $19.34; the cost for dimenhydrinate was $0.90. In this patient population, dimenhydrinate was as effective as ondansetron for the prevention of PONV and postoperative vomiting, and it was much less expensive.     

Antiemetic prophylaxis with ondansetron and methylprednisolone vs metoclopramide and methylprednisolone in mild and moderately emetogenic chemotherapy.

The purpose of the present study was to examine whether its is possible to successfully replace ondansetron (OND) with metoclopramide (MCP) in patients exposed to moderately emetogenic chemotherapy who did not experience severe nausea and vomiting while undergoing OND treatment during their first chemotherapy cycle. After switching to MCP, patients continued with this drug for three cycles, provided that they had adequate control of nausea and vomiting. Otherwise, they were switched back to OND. There were 76 patients, 60 women and 16 men, whose median age was 56 (mean 58) years. Karnofsky performance status score was 100 in 18 patients, 90 in 23, and 80 in 11 patients. No patient had previous chemotherapy. Thirty-four patients had breast cancer and received fluorouracil 500 mg/m2, epirubicin 100 500 mg/m2, and cyclophosphamide 500 mg/m2. Twelve patients had small cell lung cancer and received carboplatin 400 mg/m2 + etoposide 120 mg/m2 x 3 days. Twenty patients with ovarian cancer received carboplatin 350 mg/m2 and cyclophosphamide 500 mg/m2. Ten patients had cancer of unknown primary and received carboplatin 400 mg/m2, epirubicin 60 mg/m2, and etoposide 120 mg/m2 x 3 days. The OND schedule consisted of methylprednisolone 40 mg intravenous bolus followed by OND 8 mg in a 15-min infusion before chemotherapy, followed by OND 4 mg orally x 3 on the same and the next 2 days. Patients who did not experience nausea and vomiting with OND continued with an MCP schedule consisting of methylprednisolone 40 mg bolus followed by MCP 2 mg/kg in a 15-min infusion before chemotherapy, followed by MCP (20 mg x 4 on the day of therapy and the next 2 days after). Patients who failed with MCP or OND continued with OND. Considering our results as a whole, the intensity of nausea does not appear to influence the results of Gralla's scale. The results of Gralla's scale do not appear to be affected by the analysis of the antiemetic results and nausea on the next 2 days following chemotherapy administration. Overall, patients received 145 cycles with OND and 159 cycles with MCP. Of the 76 patients receiving OND-based antiemetic regimen during the first cycle, 13 (21%) experienced severe vomiting (Grade 2, 3) and the remaining 63 (79%) had mild or no vomiting (Grade 0, 1). Patients with Grade 0, 1 vomiting (63, 83%) continued with MCP in the second cycle. The final number of patients who failed on MCP, after 4 cycles of chemotherapy increased to 33 (43%); 43 (57%) were able to complete chemotherapy with MCP. Headache occurred in 15 (10%) cycles with OND and 8 (5%) with MCP. Flushing was noted in 12 (8%), and constipation occurred in 43 (30%) of OND cycles, and extrapyramidal manifestations occurred in 3 (5%) of patients receiving MCP. Diarrhea was noted in 3 (2%) of cycles with OND and in 28 (18%) with MCP. The cost ratio between MCP and OND was 1:14. If we administered OND only in patients who needed it, the overall cost decreased to 44%. Following the strategy applied in the present study, the cost decreased to 47%.     

Opioid-induced emesis among hospitalized nonsurgical patients: effect on pain and quality of life.

There is very little information in the medical literature regarding opioid-induced emesis and its relationship to patient outcomes. Two-hundred and six nonsurgical patients in a 400-bed teaching hospital with minimal known risks of disease-associated emesis were interviewed to examine emesis and associated outcomes following the administration of opioids for acute pain management. The mean age, weight, and height of the study group were 54.4 (+/- 19.6) years, 175.8 (+/- 45.7) pounds, and 67.1 (+/- 4.4) inches, respectively. Seventy-three (35.4%) patients experienced nausea; 28 (13.6%) patients vomited; and 15 (7.3%) patients retched following the opioid therapy. These symptoms were mild and discomforting for relatively short periods of time. The patients' ability to concentrate and eat was affected by the incidence of nausea/vomiting. The intensity, duration, and severity of nausea were positively associated with the magnitude of the functional limitations. The symptoms also influenced patients' ratings of various hospital satisfaction measures. In conclusion, emesis due to opioids represents a notable burden on nonsurgical patients. Successful therapies that prevent opioid-induced emesis are likely to positively influence patient outcomes by reducing adverse effects, improving functional outcomes, and enhancing quality of life.     

A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery

This randomized, double-blind study evaluated the relative efficacy of palonosetron (a new, selective 5-hydroxytryptamine type 3 [5-HT(3)] receptor antagonist) and ondansetron in preventing postoperative nausea and vomiting (PONV) in patients undergoing gynaecological laparoscopic surgery. Patients received either palonosetron 0.075 mg (n = 45) or ondansetron 8 mg (n = 45), intravenously, immediately before induction of general anaesthesia. The occurrence of nausea and vomiting and the severity of nausea according to a visual analogue scale were monitored immediately after the end of surgery and during the following 24 h. The incidence of PONV was significantly lower in the palonosetron group compared with the ondansetron group (42.2% vs 66.7%, respectively). There were no significant statistical differences in the visual analogue scale for nausea. In conclusion, palonosetron 0.075 mg was more effective than ondansetron 8 mg in preventing PONV.     

An open-label dose comparison study of ondansetron for the prevention of emesis associated with chemotherapy prior to bone marrow transplantation

Nausea and vomiting are significant side effects in bone marrow transplant (BMT) patients who receive high-dose preparative regimens. Higher than conventional ondansetron doses and continuous infusion might improve emetic control, because of the high doses and combinations of chemotherapy (CT) used in this setting. Our objective was to conduct a prospective, randomized study comparing two different administration methods of high-dose ondansetron during a BMT preparative regimen in breast cancer patients. Patients were eligible if they were nonpregnant women over 18 but under 65 years of age, undergoing highly emetogenic CT in preparation for autologous BMT. All patients received ondansetron as an intermittent (INT=24 mg i.v. q 12 h/day) or continuous intravenous infusion (CIV=8 mg i.v. loading dose followed by a continuous infusion of 2 mg/h per day). A total of 66 patients were enrolled in the study (n=34, INT; n=32, CIV). There was no statistical difference between treatment groups in the worst grade of emesis for the entire study period (P=0.49). Greater than 90% of all patients were graded as failures (≥5 emetic episodes or need for rescue antiemetics). Complete control (no vomiting episodes) and complete plus major control (1–2 emetic episodes) per day ranged from 8% to 85% and 11% to 91%, respectively. There was no significant difference between the treatment arms in: grade of emesis, episodes of vomiting and retching, nausea scores, and mean number of rescue medications administered. There were no differences in efficacy when high-dose ondansetron was given as CIV or INT for the control of nausea and vomiting in breast cancer patients undergoing high-dose CT for autologous BMT. Ondansetron alone was not adequate to provide sustained control of CT-induced nausea and vomiting over the entire 5-day study period. A combination of antiemetics targeting various mechanisms of CT-induced nausea and vomiting may be necessary to improve response rates.     

Procedures for preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: dexamethasone and ondansetron

This randomized double-blind study was undertaken to evaluate the efficacy of ondasetron and dexamathesone in reducing the incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy. The study covered 60 patients (ASA I/II) who had undergone laparoscopic cholecystectomy under general anesthesia. The patients were divided into two groups: 1) 30 patients who received dexamethasone, 4 mg i.v.; and 2) 30 patients who took ondansetron, 4 mg i.v., prior to general anesthesia. Postoperatively, nausea, vomiting, and severe pain (VAS) were observed every 6 hours within the first 24 hours. Postoperative nausea and vomiting occurred in 6 (20) patients in Group I and in 13 (43.33) patients in Group 2 (p < 0.05), while vomiting did only in 5 (16.66%) patients in Group I and 4 (13.33%) in Group 2 (p > 0.05). The least intensity of postoperative pain was observed in Group 1, but the difference between the study groups was insignificant. It is concluded that dexamethasone is more effective in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy than ondansetron. This is mainly determined by a significant reduction in the incidence of postoperative nausea.     

Skipping day 2 antiemetic medications may improve chemotherapy induced delayed nausea and vomiting control: results of two pilot phase II trials

Background 5HT-3 antagonists and corticosteroids control less than 50% of delayed chemotherapy induced nausea and vomiting (CINV) episodes. Materials and methods Two pilot phase II studies were conducted at our institution in which all patients received ondansetron 16 mg and dexamethasone 20 mg before highly and moderately emetogenic chemotherapy on day 1. Patients on study 1 received metoclopramide 10 mg PO q8 h, granisetron 0.5 mg PO QD and dexamethasone 8 mg QD on days 2 and 3, whereas only metoclopramide was continued on the same schedule on day 4. On study 2, patients received the same medications, but no drugs were given on day 2, and the same treatment schedule was given to them but from days 3 to 5 instead. Patients were interviewed on days 1 and 6. Results Twenty-one patients participated on each study. There were no significant clinical differences between these two studied populations. Complete CINV control occurred from days 2 to 5 in 23.1% (95% CI: 8 to 47%) on study 1 vs 61.9% (95% CI: 38 to 81%) of the patients on study 2. By logistic regression, complete CINV control was correlated significantly with antiemetic treatment group (p=0.011) even when we considered only patients who achieved complete CINV control during the first 24 h (p=0.031). Conclusions Skipping day 2 antiemetic medications does not seem to worsen delayed CINV control and may even improve it, perhaps by avoiding tachyphylaxis to these medications. A randomized controlled study is in progress to confirm these results.     

地塞米松对术后硬膜外吗啡引起恶心呕吐的预防作用

目的:评价地塞米松对硬膜外吗啡引起恶心呕吐的预防效果。方法:妇科肿瘤择期手术病人120例,随机双盲分为地塞米松(A)组、恩丹西酮(B)组、生理盐水(C)组三组,每组40人。当手术开始时,随机给予地塞米松10 mg或者恩丹西酮8 mg或者生理盐水2 mL。所有病人在手术结束前1 h均接受硬膜外吗啡2 mg,然后以0.125％布比卡因100 mL和吗啡0.12mg/kg维持硬膜外术后止痛48 h,评价镇痛效果、恶心呕吐。结果:A组和B组早期和晚期恶心呕吐发生率低于C组(P<0.05),而A组和B组无差别(P>0.05)。结论:地塞米松和恩丹西酮均能降低硬膜外吗啡引起的恶心呕吐,地塞米松对术后硬膜外吗啡引起的恶心呕吐有预防作用。     

Oral ondansetron is highly active as rescue antiemetic treatment for moderately emetogenic chemotherapy: results of a randomized phase II study

Aims  In the present phase II randomized study, two different schedules of ondansetron were investigated as rescue antiemetic treatment for delayed emesis related to moderately emetogenic chemotherapy (MEC). Materials and methods  Patients scheduled to receive a first course of MEC were randomized to ondansetron 8 mg intramuscularly (arm A) or ondansetron 16 mg orally (arm B) as rescue antiemetic treatment for delayed emesis. Efficacy and safety evaluation was performed from days 2 to 6 through the administration of a diary plus a questionnaire in which the emetic episodes and the use of the assigned rescue treatment were recorded. All patients received standard prophylaxis for delayed emesis with oral dexamethasone 8 mg daily for 4 days starting on day 2. Results  Eighty-nine patients were enrolled into the study, of whom 44 were randomized to arm A and 45 to arm B. Twenty-two patients in each arm developed grade 1–2 delayed nausea/vomiting, all of which recurred to the rescue study treatment. Oral ondansetron resulted superior to intramuscular ondansetron in terms of complete response for nausea (77.3% vs 40.9%, respectively, p = 0.01) and vomiting (81.8% vs 31.8%, respectively, p = 0.001). Both schedules resulted to be very well tolerated, and no differences in toxicity were observed between the two arms of treatment. Furthermore, personal satisfaction about the use of the assigned rescue study medication was significantly higher in arm B. Conclusions  Due to its high efficacy and excellent tolerability, oral ondansetron is an important option in the management of MEC-related delayed emesis refractory to standard antiemetic prophylaxis.     

Nausea and vomiting induced by arterial chemo-embolization in patients with hepatocellular carcinoma and the antiemetic effect of ondansetron hydrochloride

To determine the incidence of nausea and vomiting and the antiemetic effect of ondansetron hydrochloride (OND) in patients with hepatocellular carcinoma treated with arterial chemo-embolization, we studied 59 patients with hepatocellular carcinoma who were treated with transcatheter arterial embolization (TAE) or lipiodolized transcatheter arterial infusion (L-TAI). We investigated the incidence of nausea and vomiting and the amount of food intake when TAE or L-TAI was performed. All patients who experienced nausea and vomiting received OND administered prophylactically at the time of the next TAE or L-TAI to evaluate the antiemetic effect of the drug. Cumulative rates of nausea and vomiting during the week following arterial chemo-embolization were 44.8% and 27.6%, respectively. There was a tendence for the incidence to be higher in patients treated with the anticancer agent zinostatin stimalamer (SMANCS) than in those treated with epirubicin hydrochloride (EPI). Regarding food intake, 53.1% of the patients stated that they ate "half or more than half" of the food provided on the day of arterial chemo-embolization. The rate improved as time went on. In 5 patients who experienced nausea and vomiting at the time of arterial chemo-embolization, nausea and vomiting were inhibited satisfactorily by OND. When arterial chemo-embolization was performed, antiemetic treatment for approximately 3 days was necessary to improve patients' quality of life (QOL) to an acceptable level, and OND was found to be effective for the purpose in our 5 patients who had experienced nausea and/or vomiting at the previous treatment.     

Transcutaneous electrical nerve stimulation as an adjunct for controlling chemotherapy-induced nausea and vomiting in gynecologic oncology patients.

BACKGROUND: To evaluate the efficacy of a miniaturized portable transcutaneous electrical nerve stimulation (TENS) unit (ReliefBand) as an adjunct to standard antiemetic therapy for controlling nausea and vomiting induced by cisplatin-based chemotherapy in gynecologic oncology patients. METHODS: Forty-two patients were enrolled in a randomized, double-blind, placebo-controlled parallel-subjects trial with a follow-up crossover trial. All patients received a standardized antiemetic protocol, then wore the ReliefBand continuously for 7 days. RESULTS: Thirty-two patients were evaluable for the parallel-subjects component, 16 in each group. The percentage of patients with absent or minimal nausea was 59% overall, which was similar to that for both the active (56%) and placebo (62%) groups. The incidence and severity of nausea and vomiting was similar for each group. Eighteen patients completed two consecutive cycles and were evaluable for the crossover component. The average age of the crossover patients and their dose intensity were comparable with those of the overall study population (56.3 versus 58.6 years and 22.7 versus 22.7 mg/m2/week, respectively). The percentage of cycles with absent or minimal nausea was 47% overall, which was similar to that of the active (50%) and placebo (44%) cycles. However, the severity of nausea was significantly lower in the active cycles during days 2 to 4. Patients averaged less than one episode of vomiting daily in each cycle. CONCLUSIONS: The ReliefBand is an effective adjunct to standard antiemetic agents for controlling nausea induced by cisplatin-based chemotherapy in gynecologic oncology patients.     

Use of Ondansetron and Other Antiemetics in the Management of Toxic Acetaminophen Ingestions

Abstract

Background: Patients presenting with acetaminophen toxicity and vomiting are often treated with antiemetics so that orally administered N-acetylcysteine can be retained. The policy at the West Virginia Poison Center is to reserve ondansetron, an antiemetic with a higher cost than other antiemetics, as a second line agent for patients presenting within 8 hours of an acetaminophen ingestion. Methods: A retrospective study of cases between January 1993 and December 1995, in which the primary or secondary drug ingested was an adult-strength, acetaminophen-only formulation and the ingestion resulted in vomiting. Seventy-eight patients with laboratory-verified acetamin-ophen toxicity and vomiting were evaluated for the type of antiemetics used and the antiemetic's effectiveness. Results: Of the 78 acetaminophen toxic patients with vomiting, 17/51 patients (33.3%) who received a nonondansetron antiemetic failed therapy and required IV ondansetron. Of the 24 patients who received ondansetron, 4 patients (16.7%) failed therapy. All four patients who failed ondansetron therapy had previously failed other antiemetic therapy. Discussion: Although ondansetron had a lower failure rate than nonondansetron antiemetics, almost two-thirds of acetaminophen toxic patients with vomiting did not require ondansetron to control their vomiting. Health care costs would have been higher had these patients received ondansetron as their initial therapy. Antiemetics were found to be highly effective as only 3/78 patients (4%) required IV N-acetylcysteine secondary to antiemetic failure. Conclusions: Ondansetron should be utilized as a second-line agent in the management of acetaminophen toxic patients with vomiting. Because of its lower failure rate, ondansetron should be administered as a first-line agent in patients with a delay in N-acetylcysteine administration approaching 8 or more hours.