Ondansetron Compared with Granisetron in the Prophylaxis of Cyclophosphamide-lnduced Emesis in Out-Patients: A Multicentre, Double-Blind, Double-Dummy, Randomised, Parallel-Group Study
Alistair W. StewartB. McQuadeJ.D.E. CronjeL. GoedhalsA. GudgeonL CoretteX. FrogerM. Tubiana-HulinP. LaplaigeJ.T. RobertsJ. R. McRaeJohn ForsterT.V. ParasuramanM.E. Butcher
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This is the first double-blind clinical trial in a homogenous group of patients to compare the recommended dosing schedules of ondansetron and granisetron in the control of prolonged emesis after cyclophosphamide-containing chemotherapy (48% CMF, 35% EC) for breast cancer. A total of 514 patients were recruited. Of the 488 patients included in the intent-to-treat analyses, 167 were randomised to group A [8 mg ondansetron intravenously (i.v.) + placebo by mouth (p.o.) before chemotherapy + 8 mg ondansetron p.o. twice daily (b.d.) until day 5], 155 to group B (placebo i,.v. + 8 mg ondansetron p.o. before chemotherapy + 8 mg ondansetron p.o. b.d. until day 5) and 166 to group C (3 mg granisetron i.v. + placebo p.o. before chemotherapy + placebo p.o. b.d. until day 5). On study day 1, the groups were comparable with respect to the proportion of patients experiencing up to 2 emetic episodes (group A: 89%; B: 86%; C: 91%) and in the severity of nausea (no nausea; group A: 51%; B: 55%; C: 54%). Over the 5-day study period significantly more patients were rescued or withdrawn due to lack of response after the granisetron regimen (26%) than after the i.v. + p.o. ondansetron regimen (11%; p < 0.001). Since there was no difference in these parameters on day 1, this reflects differences on days 2-5 and was also reflected in the all-oral ondansetron group over this period (group B: 12%; C: 22% on days 2-5). A significant difference in the severity of nausea after i.v. and p.o. ondansetron compared with granisetron was also observed over the 5-day study period (p = 0.009). This was reflected in a numerical difference in favour of the all-p.o. ondansetron regimen compared with the granisetron regimen (no nausea; group A: 33%; B: 34%; C: 25%). Again these differences reflected differences in nausea control on days 2-5, since no differences were observed on day 1. Logistic regression analyses adjusted for prognostic factors also revealed a significant difference (p = 0.011) in favour of the i.v. + ondansetron group compared with the granisetron group when complete plus major response was compared over days 2–5. No significant differences in the safety profiles of the three treatment groups were observed. There were no severe or unexpected drug-related adverse events and as is well established for the serotonin receptor antagonists, mild constipation (mean 8%) and mild headache (mean 8%) were most commonly reported.Keywords:
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Effect of ondansetron and granisetron were evaluated in sixty (60) children (age 4-11 years) irrespective of sex, diagnosed case of acute lymphoblastic leukemia (ALL) who received high dose methotrexate and did not receive any antiemetic 24 hours prior to HDMTX. This was a prospective, randomized, double-blind, single center study. Of 60 children, 30 received oral ondansetron (4mg) and rest 30 granisetron (1mg) half an hour before therapy. Drugs were randomly allocated with appropriate code. The patients were followed up from day 1 to day 5 of therapy. Episodes of nausea and vomiting were recorded and scorings was done every 24 hours following chemotherapy. No significant difference was found between two groups according to acute emesis (Day-1) (p=0.053). In day two and day three it was significant (p<0.05). In day four it was significant (p=0.002). Early chemotherapy induced nausea and vomiting (CINV) were controlled 90% in children who received granisetron and 70% in children who received ondansetron. Delayed (Day 2-4) CINV were controlled in 80% of children who received granisetron and 43.4% who received ondansetron (p<0.05). Granisetron group required additional doses only 3.3% cases and ondanseton group 30% cases on the second day (p<0.05). Result was significant between two groups. About 36.7% patients had episodes of nausea on day four of chemotherapy in ondansetron group and it was only 3.3% in granisetron group due to adverse effects of antiemetic drug itself (p=0.001). Maximum episodes of vomiting were found on the second day in ondansetron group 33.3% and in granisetron group 3.3% (p=0.003). Though adverse effects like headache, constipation, abdominal pain and loose motion were common in both group of children but their number was much less in children who received granisetron. On second day of therapy score of nausea and vomiting was maximum in ondansetron and minimum in granisetron treated on day 4 and the result was significant. So, to prevent acute and delayed CINV in children with ALL, oral graniseteron can be considered as more effective and well tolerated with minimum adverse effects compared with ondansetrons.
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OBJECTIVE:To compare the cost-effective ratios between Granisetron and Ondansetron in the prevention of Cisplatin-induced nausea and vomiting.METHODS:In a randomized auto-controlled design,36patients receiving chemotherapy with Cisplatin were divided into2groups to compare the antiemetic effects and toxicity between Granisetron and Ondansetron and to carry out cost-effectiveness analysis.RESULTS:Granisetron could effectively prevent Cisplatin-induced nausea and vomiting and its antiemetic effect was comparable to that of Ondansetron.The average effective rates in preventing nausea and vomiting of Granisetron and Ondansetron were75.9%,77.8%and79.7%,75.0%respectively,and there were no significant differences between two drugs.The toxic reactions of Granisetron were slight.In cost-effectiveness analysis,Granisetron was better than Ondansetron.CONCLUSION:Granisetron is a safe,effective,economical antiemotic in chemotherapy of cancers.It is worth popularizing the application.
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PURPOSE: To compare the efficacy and safety of oral ondansetron with i.v. granisetron each given as a single dose prior to administration of highly emetogenic cisplatin chemotherapy. PATIENTS AND METHODS: Chemotherapy-naive patients with histologically confirmed malignancies were randomized to receive a single 24 mg ondansetron hydrochloride tablet plus a 50 ml i.v. infusion of normal saline, or a single 10 µg/kg (50 ml) i.v. infusion of granisetron plus a placebo tablet in this multicenter, double-blind, parallel-group trial. Study drug was administered 30 min prior to a single i.v. infusion of cisplatin (50-75 mg/m²), given over a period of
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PURPOSE The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (I.V.) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy. PATIENTS AND METHODS In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide- (500 to 1,200 mg/m2) or carboplatin (> or = 300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or I.V. ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. RESULTS Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and I.V. ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondonsetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; P < .001). CONCLUSION A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as I.V. ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.
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Nausea and vomiting are two of the most distressing side effects of chemotherapy. Guidelines recommend the use of 5-HT3 receptor antagonists as a pharmacologic intervention for acute and delayed nausea and vomiting for moderately and highly emetogenic chemotherapy. Although newer antiemetics and 5-HT3 receptor antagonists are available, ondansetron and granisetron still are used widely. A review of the literature was conducted to identify trials that compared the antiemetic efficacy of ondansetron and granisetron. Studies were identified by searching the PubMed®, EMBASE™, Ovid MEDLINE®, CINAHL®, and Evidence-Based Medicine Reviews databases. The six studies reviewed in this article were either a meta-analysis; a randomized, controlled trial; or another type of research study published from 2000 to date. The results reported in the studies reveal that ondansetron and granisetron have equal antiemetic efficacy in reducing or eliminating chemotherapy-induced nausea and vomiting (CINV), with the evidence classified as good based on U.S. Preventive Services Task Force criteria for judging the strength of the overall evidence. Although side effects of ondansetron and granisetron have been reported, they normally are mild and of brief duration, not severe or lasting enough to warrant discontinuation.
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A 1-year-old girl with stage-IV neuroblastoma developed ondansetron hydrochloride anaphylaxis. Safe use of granisetron as an antiemetic after skin prick, oral, and intravenous challenge tests is presented. We present this case to emphasize that ondansetron hydrochloride may cause a serious anaphylactic reaction. In such a case, granisetron may be given to patients as an antiemetic after some provocative tests performed.
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Survey of Anesthesiology: April 2007 - Volume 51 - Issue 2 - p 106-107 doi: 10.1097/01.sa.0000258198.00647.51
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To the Editor: Current therapy of patients who have postoperative nausea and vomiting (PONV) despite prophylaxis is to switch to a different antiemetic from another class (1). A redosing study (2) determined that when intraoperative prophylactic ondansetron was unsuccessful, repeating it in the PACU did not have additional efficacy. Redosing studies in chemotherapy-induced nausea and vomiting (CINV) (3–5) suggest changing to a different member of the same 5-hydroxytryptamine (5-HT3) antagonist class allows increased efficacy. Although the 5-HT3 antagonists have structural similarities to serotonin, there are side chain differences. Granisetron’s effectiveness for failed ondansetron CINV patients may be related to side chain differences and increased receptor binding. Granisetron is highly specific (1000:1) for the 5-HT3 receptor, but ondansetron also has nonspecific binding to 5-HT1A and 5-HT1B(6). Granisetron has a longer plasma half-life versus ondansetron (4.9 to 7.7 h (7) vs 3.5 to 5.5 h (8), respectively). Ondansetron’s metabolism is affected by variations of the cytochrome P450 CYP2D6 genotype, with ultrarapid metabolism causing decreased response to ondansetron (9).Granisetron is metabolized by CYP3A, not CYP2D6 (10), suggesting that granisetron may be able to rescue within class. Whether this observation is transferable from CINV to PONV, from ondansetron to other same-class members and vice versa, suggests lessons from the CINV model and merits a PONV study. Anthony L. Kovac, MD
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Granisetron is equivalent to ondansetron for prophylaxis of chemotherapy-induced nausea and vomiting
The introduction of serotonin antagonists as antiemetics for prophylaxis of chemotherapy-induced nausea and vomiting represented a major step toward better patient tolerance and adherence to this type of treatment. Several published trials compared different serotonin antagonists without demonstrating clear superiority of any one of them. Because most of these trials compared ondansetron with granisetron, the authors conducted a meta-analysis to determine if the current data available show any therapeutic difference between them.MEDLINE and CANCERLIT databases were searched from 1990 to May 1999, and pertinent article references also were surveyed, without restriction to English language. The authors included all randomized controlled trials (RCTs) that had more than 25 patients per arm and compared ondansetron to granisetron for prophylaxis of acute (A) (< 24 hours) and delayed (D) (> 24 hours) nausea (N) and vomiting (V) induced by highly (H) or moderately (M) emetogenic chemotherapy. Only the first chemotherapy cycle was considered for studies that involved a crossover design.Fourteen studies with 6467 evaluable patients among the 21 studies retrieved were selected for this meta-analysis. In none of the eight scenarios studied (AHV, AHN, AMV, AMN, DHV, DHN, DMV, and DMN) could the authors detect any significant differences in the antiemetic efficacy of any of these medications.The authors conclude that both granisetron and ondansetron have similar antiemetic efficacy for prophylaxis of chemotherapy-induced nausea and vomiting. Because the number of comparative studies that addressed the delayed nausea and vomiting scenarios is low, further RCTs are still needed to confirm these results.
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This prospective study was designed to compare the efficacy of ondansetron with granisetron in terms of complete emesis control and time spent in an ambulatory care setting in children with acute lymphoblastic leukemia (ALL) undergoing moderately emetogenic cyclophosphamide-based chemotherapy.The costs for both treatments are also examined. A total of 33 children (mean age: 7.8 ± 4.9 year) were studied during 66 chemotherapy cycles. Analysis was based on 33 courses of a single oral dose of granisetron and 33 courses of ondansetron incorporating 2 intravenous doses of ondansetron 0.15 mg/kg followed by 1 dose of the same dosage orally. There was no significant difference between the 2 treatments in terms of overall efficacy (McNemar's chi-square test). Twenty of 33 patients (60.6%) receiving granisetron and 15 of 33 patients (45.5%) receiving ondansetron experienced no emesis 24 h after chemotherapy (p = .227). Boys experienced greater rates of vomiting than did girls despite antiemetic treatment; however, no apparent reason for the gender discrepancy was noted. Both antiemetic regimens have similar antiemetic efficacy for treating the moderately emetogenic effects associated with cyclophosphamide-based chemotherapy. It is possible that the granisetron regimen may be preferable because it is simpler to administer and more cost-effective.
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