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PubMed1993

Dexamethasone plus ondansetron versus dexamethasone plus alizapride in the prevention of emesis induced by cisplatin-containing chemotherapies for urological cancers.

Thirty-six consecutive patients, who were to be treated with cisplatin-based chemotherapy for testicular or bladder cancer, underwent a single-blind randomized study to compare the antiemetic therapies with dexamethasone (DEX)+ondansetron (OND) and DEX + alizapride (ALI). Eighteen patients were assigned to each arm. DEX, 20 mg in 100 ml saline was administered i.v. 30 min prior to cisplatin, OND, 8 mg, or ALI, 100 mg in 100 ml saline were administered i.v. 15 min prior to cisplatin and repeated 4 and eventually 8 h later. Chemotherapy regimens contained cisplatin 25 mg/m2 for 4 consecutive days to be repeated for 4 courses every 4 weeks. During the first course a complete emetic control was observed in 15 (83%) and partial in 3 of the 18 patients treated with DEX + OND versus only 2 complete and 7 partial responses and 9 (50%) failures among the 18 patients treated with DEX + ALI. Thirty-one patients were evaluable for 4 courses of therapy. Complete emetic control was achieved in 11 (69%) and partial in 5 (31%) among the 16 patients treated with DEX + OND, versus only 1 (7%) partial response and 14 (93%) failures among the 15 treated with DEX + ALI (p < 0.001). Furthermore, DEX + OND gave a complete antiemetic control in 13 out of 14 patients who had failed DEX + ALI. Delayed vomiting was observed in 4 (22%) of 18 patients primarily treated with DEX + OND and in 1 (7%) of the 15 patients subsequently treated. Constipation and headache occurred more frequently among patients treated with DEX + OND, but there was no significant difference with DEX + ALI. Hiccup was significantly more frequent among patients treated with DEX + ALI.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1985

Sequential therapy with lithium in chemotherapy-induced vomiting.

Having noticed psychotic traits in some patients showing incoercible vomiting due to antineoplastic drugs we have thought of establishing a therapy with lithium in the days preceding the therapeutic cycle in order to reduce the emetic events. The effectiveness of lithium carbonate (600 mg/mq p.o./day for one week) in the prevention or reduction of vomiting induced by antiblastic therapy has been checked in comparison with metoclopramide and domperidone in 40 patients. In the group pretreated with lithium, 80% of the cases showed favorable results. In the control groups, on the contrary, the efficacy of the antiemetic therapy has shown to be of lesser importance (55%). The undesirable side-effects of lithium appear to be irrelevant. We therefore think that pretreatment with lithium may become, in selected cases not affected by traditional antiemetics, of great importance in the control of emetic symptomatology.

Adolescent↗
PubMed1999

The effect of midazolam on persistent postoperative nausea and vomiting.

The effect of intravenous midazolam on persistent postoperative nausea and vomiting (PONV) was compared to placebo in a prospective randomized double-blind study. Twenty patients aged 18 to 82 years with persistent PONV resistant to standard anti-emetics and present for greater than six hours were randomized to receive either an intravenous infusion of midazolam 1.0 mg/h or placebo. Nausea (P = 0.04), vomiting (P = 0.02) and the use of rescue anti-emetics (P = 0.003) were significantly less in the midazolam group. We conclude that low-dose intravenous infusion of midazolam significantly reduces persistent PONV.

Adult↗
PubMed1999

Propofol-thiopentone admixture: recovery characteristics.

We have investigated, in a prospective double-blind study, recovery from anaesthesia induced by two admixtures of propofol and thiopentone and compared it with a third group of patients who received propofol and lignocaine. Ninety unpremedicated ASA 1 or 2 patients scheduled for elective gynaecological laparoscopy as a daycase procedure were randomly allocated to receive one of three different mixtures for induction of anaesthesia as part of a standardized anaesthetic: Group P50: propofol 1% 10 ml/thiopentone 2.5% 10 ml, Group P75: propofol 1% 15 ml/thiopentone 2.5% 5 ml, Group P100: propofol 1% 20 ml/lignocaine 1% 4 ml. Recovery from anaesthesia was assessed for up to four hours post-induction by critical flicker fusion threshold and best post-box toy completion time. Comparison was made with preoperative baseline performance. There was no significant difference in postoperative recovery between the three groups with either assessment but no group returned to their mean preoperative performance levels within the first four hours post-induction. Nor was there any difference between the groups with respect to postoperative analgesia or anti-emetic administration. Utilizing the most sensitive end-point, a sample of nearly 1000 patients in each group would be required to confirm the observed difference with a power of 0.8 based on the data from this study. In comparison with lignocaine, the addition of thiopentone to propofol does not delay recovery from anaesthesia and does not increase postoperative analgesic or anti-emetic requirements.

Adult↗
PubMedDate not supplied

Ondansetron usage in HIV positive patients: a pilot study on the control of nausea and vomiting in patients on high dose co-trimoxazole for Pneumocystis carinii pneumonia.

This was an open, single centre study, to evaluate the safety and efficacy of ondansetron in the treatment of co-trimoxazole associated nausea and vomiting in AIDS patients. Sixteen patients presenting with their first episode of HIV-associated Pneumocystis carinii pneumonia (PCP) on high dose co-trimoxazole were given ondansetron 8 mg orally, every 8 h. Measurements were made from data recorded by each patient on diary cards. In this study 11 out of 16 (69%) patients on ondansetron experienced good control of emesis (2 or less emetic episodes) on their 'worst day' of therapy and 8 out of 16 (50%) of patients demonstrated good control of emesis throughout their treatment with co-trimoxazole. Good control of nausea (mild or none) was achieved in 7 out of 16 (47%) patients. A total of 7 patients were able to complete the full course of co-trimoxazole whilst on ondansetron. One serious adverse event (Stevens-Johnson syndrome) was reported and felt to be unrelated to ondansetron. If conventional anti-emetics fail to achieve control of symptoms or have unacceptable side effects, ondansetron may represent a possible alternative.

AIDS-Related Opportunistic Infections↗
PubMed2006

5-Hydroxyindoleacetic acid and substance P profiles in patients receiving emetogenic chemotherapy.

BACKGROUND: Even though direct cause and effect has not been proved, clinical evidence suggests serotonin and substance P (SP) are involved in the emetic response following chemotherapy. Because of several parallels, we hypothesized that SP release, like serotonin, may be propagated by chemotherapy and both substances can be measured in biological fluids, and correlated with a particular phase of emesis. METHODS: Urinary 5-hydroxyindoleacetic acid (5-HIAA) was assessed by HPLC; serum and urine SP were measured by immunoassay. In addition to construction of neurotransmitter profiles, all SP data were grouped according to cisplatin dosages, = or >75 mg/m(2) versus <75 mg/m(2), and phase of emesis, acute versus delayed. Analyses of these data were performed by repeated measures analysis of variance. RESULTS: Samples were collected over a 72-hour period from 26 adult patients who received cisplatin- (n = 13) or non-cisplatin-containing (n = 13) chemotherapy. Mean baseline 5-HIAA: creatinine ratios were 5.23 and 5.16 in females and males, respectively; mean baseline SP levels were 392 and 181 pg/mL in females and males, respectively. Comparisons between SP data stratified by cisplatin dosage and emetic phase were significantly different, P < 0.0001. CONCLUSIONS: Laboratory studies provide additional evidence that serotonin and SP are involved primarily, though not exclusively, in acute and delayed vomiting, respectively.

Adult↗
PubMedDate not supplied

Efficacy of prophylactic ondansetron in a patient-controlled analgesia environment.

We conducted a prospective, randomized, double-blind, placebo-controlled trial to examine the efficacy of prophylactic ondansetron on post-operative nausea and vomiting (PONV) during opioid patient-controlled analgesia (PCA). In total, 374 patients using opioid PCA, but otherwise considered to be low risk for PONV, were randomly allocated to ondansetron (4 mg given intravenously and 16 mg added into the PCA pump) or saline (control group). PONV was evaluated in terms of nausea graded on a visual analogue scale, and the number of patients who experienced emetic episodes or needed rescue anti-emetics in the 48-h post-operative period. Patient satisfaction for PCA was scored at the end of the evaluation period. The only difference between the two groups was the higher number of headaches in the ondansetron group. In patients using opioid PCA, but with no other high risk factors for PONV, prophylactic ondansetron does not have any clinical benefit.

Aged↗
PubMed1999

Systematic review of ondansetron for the prevention and treatment of postoperative nausea and vomiting in adults.

OBJECTIVES: To determine the efficacy and safety of ondansetron for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults. DESIGN: Systematic review of published double-blind randomised controlled trials. DATA SOURCES: Twenty seven trials from 1990 to July 1998 retrieved from a systematic literature search (Medline, Cinahl, Embase, Cochrane Library, reference lists, hand searching of anaesthetic journals, & provided manufacturer information); restricted to English language. MAIN OUTCOME MEASURES: Estimation of efficacy (incidence of complete absence of nausea or other outcome measure as defined by the authors) at 24 hours. RESULTS: Seven double-blind randomised controlled trials with 1,623 patients studied intravenous ondansetron 1 mg, 4 mg, or 8 mg for the treatment of postoperative nausea and vomiting (PONV). Four mg, compared with metoclopramide 10 mg, produced higher patient satisfaction scores and an increased incidence of freedom from nausea at 24 hours. Further studies are required to compare the safety, efficacy and dose response with other anti-emetics at 24 hours. Twenty double-blind randomised controlled trials with 4,364 patients studied intravenous and oral administration of ondansetron 1 mg, 4 mg, and 8 mg for the prevention of postoperative nausea and vomiting. There appears to be no significant difference between droperidol (0.625 mg, 1 mg or 1.25 mg) i.v. and ondansetron 4 mg in efficacy and incidence of side effects. Compared with metoclopramide, ondansetron produced less nausea but the incidence of vomiting was the same at 24 hours. CONCLUSIONS: Further PONV could be prevented with ondansetron 4 mg compared with placebo and metoclopramide 10 mg. Further studies are required to compare ondansetron with other anti-emetics for the treatment of PONV. For prophylaxis of PONV ondansetron 4 mg appears to be equal to low dose droperidol in efficacy and the incidence of side effects, and superior to metoclopramide. Ondansetron should perhaps be limited to second line treatment in view of patient satisfaction, efficacy and cost when compared with droperidol.

Adult↗
PubMed1996

Prevention of delayed emesis by a single intravenous bolus dose of 5-HT3-receptor-antagonist in moderately emetogenic chemotherapy.

While the use of 5-HT3 receptor antagonists is clearly justified in patients receiving cisplatin, their role with less emetic drugs is still not defined. The aim of our randomized study was to verify the efficacy of the single standard dose of three 5-HT3-receptor-antagonists in moderately emetic chemotherapies. Sixty chemotherapy-naive breast cancer patients of 30 to 71 years in age, P.S. = 0-1, receiving 5-fluorouracil-epirubicin-cyclophosphamide (FEC 75) q 21 days or cyclophosphamide-methotrexate-5-fluorouracil (CMF) or 120 mg/m2 epirubicin or high dose mitomycin-methotrexate-mitoxantrone (MMM) q 14 days (+ G-CSF) or 100 mg/m2 epirubicin (+ G-CSF) were randomized to receive, 15 min before chemotherapy, 8 mg i.v. bolus of ondansetron or 3 mg i.v. granisetron or 5 mg i.v. tropisetron and no further antiemetic therapy in the following days. 180 cycles were evaluable. Complete protection, (the absence of vomiting episodes,) was respectively 75%, 70% and 70% in the acute and 70%, 82%, 72% in the delayed phases, and an absence of nausea was 56%, 37% and 20% in the acute phase and 50%, 35% and 27% in the delayed, respectively. Complete response, (absence of vomiting and absence or mild nausea,) was 74%, 58.6% and 50.8% in the acute and 64%, 63.7%, 47.3% in the delayed phases, respectively. At the statistical analysis no significant differences between the three drugs were found regarding acute vomiting while ondansetron was superior to granisetron and tropisetron in acute (p = 0.018; p < 0.05) and delayed nausea (P = 0.104; p < 0.01). This activity is practically the same as that we reported (Ann Oncol 1994; 6, suppl 8: 204) with a loading dose on day 1 and maintenance for the following 2-5 days, but with a significantly favorable cost-benefit ratio.

Adolescent↗
PubMed2006

Systematic review on the recurrence of postoperative nausea and vomiting after a first episode in the recovery room - implications for the treatment of PONV and related clinical trials.

BACKGROUND: Despite the presence of a plethora of publications on the prevention of postoperative nausea and vomiting (PONV) only little is known how to treat established symptoms. Besides the high effort of performing these efficacy trials (much more patients must give their consent than are actually included in a study) and ethical concerns, little is known about the rate of re-occurring PONV/vomiting after placebo. As a consequence investigators will have difficulties defining a clinically relevant effect for the new treatment which is crucial for any planning. A quantitative systematic review was performed in order to provide more reliable estimates of the incidence of re-occurring PONV/vomiting after placebo and to help investigators defining a clinically relevant treatment effect. METHODS: A systematic search of the literature was performed using an extended search strategy of a previous review. Data on the recurrence of PONV (any nausea or emetic symptom) and vomiting (retching or vomiting) was extracted from published reports treating PONV with placebo and unpublished results from two observational trials where no treatment was given. A nonlinear random effects model was used to calculate estimates of the recurrence of symptoms and their 95%-confidence intervals (95%-CI). RESULTS: A total of 29 trials (including the unpublished data) were eligible for the calculations. Depending on the length of observation after administering placebo or no treatment the recurrence rate of PONV was between 65% (95%-CI: 53%...75%) and 84% (95%-CI: 73%...91%) and that of vomiting was between 65% (95%-CI: 44%...81%) and 78% (95%-CI: 59%...90%). CONCLUSION: Almost all trials showed a considerable and consistently high rate of recurrence of emetic symptoms after placebo highlighting the need for a consequent antiemetic treatment. Future (placebo) controlled efficacy trials may use the presented empirical estimates for defining clinically relevant effects and for statistical power considerations.

Journal Article↗
PubMed2005

Scutellaria baicalensis decreases ritonavir-induced nausea.

BACKGROUND: Protease inhibitors, particularly ritonavir, causes significant gastrointestinal disturbances such as nausea, even at low doses. This ritonavir-induced nausea could be related to its oxidative stress in the gut. Alleviation of drug-induced nausea is important in effectively increasing patients' compliance and improving their quality of life. Conventional anti-emetic drugs can only partially abate the symptoms in these patients, and their cost has also been a concern. Rats respond to nausea-producing emetic stimuli by increasing consumption of non-nutritive substances like kaolin or clay, a phenomenon known as pica. In this study, we used this rat pica model to evaluate the effects of Scutellaria baicalensis, a commonly used oriental herbal medicine, on ritonavir-induced nausea. RESULTS: Rats treated with 20 mg/kg ritonavir significant caused increases of kaolin consumption at 24 to 48 hr (P < 0.01). Pretreatment with 0.3 and 3 mg/kg Scutellaria baicalensis extract significantly decreased ritonavir-induced kaolin intake in a dose-related manner (P < 0.01). Compared to vehicle treatment, the extract completely prevented ritonavir-induced kaolin consumption at dose 3 mg/kg. The area under the curves (AUC) for kaolin intake from time 0 to 120 hr for vehicle only, ritonavir only, SbE 0.3 mg/kg plus ritonavir, and SbE 3 mg/kg plus ritonavir were 27.3 g x hr, 146.7 g x hr, 123.2 g x hr, and 32.7 g x hr, respectively. The reduction in area under the curves of kaolin intake from time 0 to 120 hr between ritonavir only and SbE 0.3 mg/kg plus ritonavir, ritonavir only and SbE 3 mg/kg plus ritonavir were 16.0% and 77.7%, respectively. CONCLUSION: Scutellaria baicalensis significantly attenuated ritonavir-induced pica, and demonstrated a potential in treating ritonavir-induced nausea.

Journal Article↗
PubMed1984

Combination metoclopramide and dexamethasone: an effective antiemetic regimen in outpatients receiving non-cisplatin chemotherapy.

In a pilot study a combination of metoclopramide and dexamethasone was administered to 29 patients receiving emetogenic chemotherapy. Metoclopramide was given intravenously (IV) at a dose of 0.5 mg/kg one-half hour before the start of chemotherapy, and then given at the same dose orally two, five, and eight hours after chemotherapy. Dexamethasone was given at a dose of 10 mg IV immediately following the first dose of metoclopramide, then given at a dose of 8 mg orally six, 12, and 18 hours after chemotherapy. The chemotherapy regimens most commonly used were standard FAC, FAM, and BACOD regimens. Twenty-six of 29 patients received outpatient treatment. Complete protection against both nausea and vomiting was seen in 69% (20/29) patients; six others (21%) experienced mild nausea but no vomiting, resulting in 90% (26/29) of the patients having total emetic protection with combination metoclopramide and dexamethasone. Eighty-eight percent (15/17) of the patients with no prior chemotherapy had no nausea or vomiting, one (6%) had only mild nausea, and the remaining patient (6%) had one emesis. Forty-two percent (5/12) of the patients with prior chemotherapy had complete antinausea and emetic protection, five (42%) had nausea without vomiting, and the remaining two patients experienced one or two emesis. Side effects were minimal when present and included mild drowsiness (five patients), akathisia (three patients), diarrhea (one patient), and hot flashes (one patient). Combination metoclopramide and dexamethasone therapy can effectively prevent emesis in 94% of patients receiving potentially emetogenic chemotherapy and can prevent nausea and emesis in 88% of untreated patients. Studies defining the optimal dose and scheduling needed to maintain such antinausea and antiemetic protection are necessary.

Adult↗
PubMed1987

Carboplatin and recurrent childhood brain tumors.

Carboplatin, a cisplatin analogue, was administered as an intravenous (IV) one-hour infusion in a 4-consecutive weekly dose schedule to 44 patients with recurrent childhood brain tumors. Twenty-four patients were registered on our phase I, and 20 on our phase II studies. The maximum tolerable dose derived from our phase I study was 210 mg/m2/wk in patients with solid tumors, and the recommended dose for subsequent pediatric phase II studies was 175 mg/m2/wk. This dose was administered to 14 patients in the phase I and all 20 patients in the phase II study. Nine of 36 (25%) evaluable patients in the combined studies experienced objective responses for a median duration of 10+ months. Seven of nine responders had received prior cisplatin. Disease-specific response rates were as follows: medulloblastoma, six of 14 (43%) with three complete (CR) and three partial responses (PR); pineoblastoma, one of one (PR); germinoma, one of two (CR); and brainstem glioma, one of eight (13%) (PR). Carboplatin had mild emetic effects but no significant auditory or renal toxicity. Thrombocytopenia (less than 49,000) was encountered in nine of 28 (32%) evaluable trials at a dose of 175 mg/m2/wk. Because of its low potential for auditory, renal, and emetic toxicity, ease of administration, and high disease-specific activity, carboplatin deserves further study in multiagent phase II and III trials, especially in chemotherapy-sensitive diseases such as medulloblastoma.

Adolescent↗
PubMed1990

Ondansetron: a new antiemetic for patients receiving cisplatin chemotherapy.

GR 38032F (ondansetron) is a selective serotonin subtype-3 receptor antagonist with reported antiemetic efficacy in patients receiving cisplatin. This study evaluated the safety and efficacy of ondansetron in three consecutive nonrandomized groups of patients who were receiving a 4- or 5-day regimen of cisplatin (20 to 40 mg/m2/d) combination chemotherapy. Thirty-six patients were enrolled. Thirty-five patients were assessable for efficacy. All patients received three daily intravenous doses of 0.15 mg/kg of ondansetron. Twenty-four patients had received no prior chemotherapy. Twelve of these received ondansetron every 2 hours and 12 received ondansetron every 6 hours. Twelve additional patients who had received at least one prior course of chemotherapy were administered ondansetron every 6 hours. All patients were monitored for emetic episodes (vomiting or retching), adverse events, and laboratory safety parameters. Ten patients (29%) had no vomiting or retching throughout the entire study period and 18 patients (51%) experienced two or fewer emetic episodes during the entire study period. The greatest antiemetic efficacy was on day 1 when 27 patients (77%) had no emesis. The chemotherapy-naive patients responded better than the nonnaive patients on all study days. Reported adverse events were minor, with the most common possibly drug-related event being headache (14% of patients). No extrapyramidal symptoms were observed. Transient increases in total SGOT, and SGPT were observed in some patients.

Adult↗
PubMed1990

A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis induced by cyclophosphamide, fluorouracil, and doxorubicin or epirubicin chemotherapy.

Seventy-five breast cancer patients scheduled to receive a first course (in a new cycle) of cyclophosphamide, fluorouracil, and doxorubicin (FAC) or epirubicin (FEC) participated in a double-blind crossover study to compare the antiemetic efficacy and safety of ondansetron (GR38032), a 5-hydroxytryptamine3 (5-HT3) receptor antagonist, and metoclopramide. Ondansetron was given as an 8 mg loading dose (4 mg intravenously [IV] plus 4 mg orally) before chemotherapy followed by 8 mg every 8 hours orally for 3 to 5 days. Metoclopramide was given as an 80 mg loading dose (60 mg IV plus 20 mg orally) before chemotherapy followed by 20 mg every 8 hours orally for 3 to 5 days. A "period" interaction in the analysis of emetic response in the first 24 hours necessitated a parallel group analysis of first treatments only, 68 patients being assessable for this parameter. In the first 24 hours, complete or major control (zero to two emetic episodes) of emesis was achieved in 30 of 35 (86%) patients receiving ondansetron and in 14 of 33 (42%) patients receiving metoclopramide (P less than .001). Ondansetron was also more effective in reducing acute nausea. On days 2 to 3, the complete or major responses were significantly better with ondansetron (81% v 65%; P = .033), but there was no statistical difference in the control of nausea. There was a significant patient preference for ondansetron (63% v 26%; P = .001). Extrapyramidal reactions were observed in two metoclopramide treatments; both treatments were otherwise well tolerated. These results are consistent with serotonin (5-HT), being a significant neurotransmitter of cyclophosphamide/doxorubicin- or epirubicin/fluorouracil-induced emesis.

Administration, Oral↗
PubMed1991

A single-blind comparison of intravenous ondansetron, a selective serotonin antagonist, with intravenous metoclopramide in the prevention of nausea and vomiting associated with high-dose cisplatin chemotherapy.

Ondansetron (GR 38032F), a selective antagonist of serotonin subtype 3 receptors, is effective in the prevention of emesis associated with cisplatin as well as other chemotherapeutic agents. In this randomized, single-blind, multicenter, parallel group study, we compared the efficacy and safety of intravenous (IV) ondansetron with IV metoclopramide in the prevention of nausea and vomiting associated with high-dose (greater than or equal to 100 mg/m2) cisplatin chemotherapy. Three hundred seven patients receiving their first dose of cisplatin, either alone or in combination with other antineoplastic agents, were randomized to receive ondansetron 0.15 mg/kg IV every 4 hours for three doses or metoclopramide 2 mg/kg IV every 2 hours for three doses, then every 3 hours for three additional doses. The study prohibited the concurrent administration of other antiemetics or dexamethasone. Patients receiving ondansetron had a higher rate of complete protection from emesis (40% v 30%, P = .07), a higher complete plus major response rate (65% v 51%, P = .016), a lower rate of failure (21% v 36%, P = .007), and a lower median number of emetic episodes (one v two, P = .005) than did those receiving metoclopramide. The median time to the first emetic episode was longer on ondansetron (20.5 v 4.3 hours, P less than .001). Adverse events occurred in 48% of patients receiving ondansetron and 69% of those receiving metoclopramide (P less than .001). Akathisia and acute dystonic reactions occurred only on metoclopramide; headache (controlled with acetaminophen) was significantly more frequent with ondansetron. Ondansetron is more effective, produces fewer adverse events, and is easier to administer than metoclopramide for the prevention of emesis associated with high-dose cisplatin chemotherapy.

Adult↗
PubMed1995

Adjusting the dose of intravenous ondansetron plus dexamethasone to the emetogenic potential of the chemotherapy regimen.

PURPOSE: This pilot, open-label study evaluates the antiemetic efficacy and safety of a single 20-mg intravenous (IV) dose of dexamethasone combined with a single IV dose of ondansetron (32, 24, or 8 mg) in patients receiving highly emetogenic (HE), moderately high emetogenic (MHE), or moderately emetogenic (ME) chemotherapy, respectively. PATIENTS AND METHODS: One hundred forty-six patients received a single 20-mg IV dose of dexamethasone over 15 minutes beginning 45 minutes before chemotherapy and either a single 32-, 24-, or 8-mg IV dose of ondansetron over 15 minutes beginning 30 minutes before chemotherapy. Patients were evaluated for emetic episodes, extent of nausea, and adverse events for 24 hours after chemotherapy. RESULTS: Complete response (no emetic episodes) was noted in 72% (95% confidence interval [CI], 60% to 84%), 88% (95% CI, 79% to 97%), and 77% (95% CI, 63% to 92%) of patients in the HE, MHE, and ME categories, respectively. The proportion of patients who experienced no nausea on the posttreatment assessment was 51% (95% CI, 37% to 64%), 69% (95% CI, 56% to 81%), and 47% (95% CI, 29% to 65%), respectively. The antiemetic regimens were all well tolerated. The proportion of patients with any drug-related adverse events did not vary across the three study groups despite the range of ondansetron doses and variety of chemotherapy regimens. Mild headache was noted in 28% of patients. Other adverse events, all of which were noted in fewer than 10% of patients, included lightheadedness, fatigue, dizziness, and constipation. CONCLUSION: A single IV dose of either 8, 24, or 32 mg of ondansetron combined with a single 20-mg IV dose of dexamethasone resulted in good control of acute emesis across a wide spectrum of chemotherapy regimens. Nausea control proved somewhat more difficult, with approximately 50% of patients in the HE and ME emetogenic categories experiencing some degree of nausea. The results of our pilot study suggest that adjusting the dose of ondansetron to the intrinsic emetogenicity of the chemotherapy regimen permits a more efficient use of ondansetron while maintaining good antiemetic control. Such an approach appears worthy of further investigation.

Adult↗
PubMed1996

Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. Dolasetron Comparative Chemotherapy-induced Emesis Prevention Group.

PURPOSE: To assess the comparative antiemetic efficacy of single-dose intravenous (IV) dolasetron mesylate and ondansetron in preventing cisplatin-induced nausea and vomiting. PATIENTS AND METHODS: Cancer patients (n = 609) receiving first-course cisplatin chemotherapy were randomized to one of three treatments: 1.8 or 2.4 mg/kg dolasetron mesylate salt (equivalent to 1.3 and 1.8 mg/kg dolasetron base, respectively) or 32 mg ondansetron. Each treatment was infused over 15 minutes, 30 minutes before cisplatin administration. Patients were stratified to cisplatin doses of > or = 70 and less than 91 mg/m2 (n = 368) or > or = 91 mg/m2 (n = 241), administered over < or = 3 hours. Protocol-defined efficacy criteria included complete response (zero emetic episodes and no rescue medication), major response (1 to 2 emetic episodes and no rescue medication), and patients' report of nausea severity and satisfaction recorded on a 100-mm visual analog scale (VAS). RESULTS: The three treatments met protocol-specified criteria for equivalence. Complete response rates for dolasetron mesylate 1.8 mg/kg, 2.4 mg/kg, and ondansetron, respectively, were 49.2%, 45.6%, and 50.4% for patients in the lower cisplatin stratum (mean, 74.7 mg/m2) and 36.8%, 31.3%, and 31.8% in the higher cisplatin stratum (mean, 100.6 mg/m2). No significant differences were observed in the extent of nausea with either dolasetron dose compared with ondansetron. Less nausea was noted with 1.8 mg/kg dolasetron compared with the 2.4 mg/kg dose (P = .044) All three antiemetic treatments were well tolerated. Asymptomatic electrocardiogram changes were recorded with both dolasetron and ondansetron. CONCLUSION: A single IV dose of dolasetron mesylate (1.8 or 2.4 mg/kg) has comparable safety and efficacy to a single 32-mg IV dose of ondansetron in patients receiving cisplatin chemotherapy.

Adult↗