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At least 19 recordsLinked to original sources
PubMed1999

[Efficacy of combination with granisetron and methylprednisolone for nausea, vomiting and appetite loss in remission induction chemotherapy of acute myeloid leukemia--a randomized comparative trial between granisetron alone and granisetron plus methylprednisolone].

The prevention of nausea, vomiting and appetite loss induced by remission induction chemotherapy for acute myeloid leukemia was compared by randomization between granisetron alone and combination with granisetron plus methylprednisolone. Granisetron was administered at 40 micrograms/kg during chemotherapy, and methylprednisolone was administered concomitantly at 125 mg/body for 3 days or more in the combination group. The single and combination groups comprised 14 and 13 patients, respectively, and there was no significant difference between the background of both groups. To evaluate the effect they were scored according to 4 grades, and evaluated every 24 hours from the start of chemotherapy to 5 days after its completion. The complete inhibition rate of vomiting was as high as 71.4% and 92.3% in the single and combination groups, respectively, showing no significant difference. The grade of vomiting was mild in both groups. Nausea was noted in 71.4% and 46.2%, respectively, and the inhibitory effect tended to be higher in the combination group. Appetite loss developed in 92.9% and 41.7%, respectively, and the prevention effect was clearly higher in the combination group. The prevention effects on nausea 7, 8 and 10 days after the start of chemotherapy, on appetite loss 2-10 days after it, and 2-5 days after its completion, were higher in the combination group. Granisetron revealed an excellent inhibitory effect on vomiting induced by remission induction chemotherapy for acute myeloid leukemia, but combination with granisetron and methylprednisolone was considered useful for nausea in the latter half of the treatment period and for appetite loss during the whole period.

Acute Disease↗
PubMed1993

[Antiemetic efficacy of granisetron in pediatric cancer treatment--(2). Comparison of granisetron and granisetron plus methylprednisolone as antiemetic prophylaxis].

A crossover clinical trial was carried out to compare the effectiveness and safety of granisetron alone (40 micrograms/kg) with that from a combination of granisetron plus methylprednisolone (MPL, 10 mg/kg) for control of emesis and vomiting induced by anticancer drugs in children with cancer. Complete control of emesis and vomiting were achieved in 95% (19/20 cases) of patients receiving the combination compared to 85% (17/20 cases) of patients receiving granisetron alone. There were no clinical toxicities or side effects in either treatment group. These data indicated that the combination of granisetron plus MPL was superior for control of emesis and vomiting in children receiving cytostatic anticancer drugs.

Adolescent↗
PubMed1992

A comparison of granisetron as a single agent with conventional combination antiemetic therapies in the treatment of cytostatic-induced emesis. The Granisetron Study Group.

The safety and efficacy of intravenous granisetron were compared with combinations of conventional antiemetics in two single-blind, parallel-group studies which have been reported previously. In this review updated data from both studies is presented. In both studies granisetron (40 micrograms/kg) was given as a single 5-min infusion before chemotherapy with two additional doses allowed to control subsequent nausea and vomiting. All patients were naive to chemotherapy. Patients due to receive cisplatin (greater than 49 mg/m2) were randomly assigned to receive either granisetron alone or metoclopramide (3 mg/kg) plus dexamethasone (12 mg) given prophylactically followed by an 8-h infusion of metoclopramide (4 mg/kg). In the 24 h after the start of chemotherapy 70% of granisetron-treated patients and 67% of comparator group were complete responders. In patients due to receive moderately emetogenic chemotherapy, granisetron was compared with chlorpromazine (up to 200 mg/24 h) plus dexamethasone (12 mg). Twenty-four hour efficacy was significantly higher in the granisetron group with complete response in 68% of patients compared to 47% in the comparator group (P less than 0.001). A subset of 40 patients in this study were crossed over to receive the alternative antiemetic on their next cycle of chemotherapy. A significant majority of patients (32/34; 94%) preferred granisetron (P less than 0.001). Around 80% of the granisetron-treated patients in both groups required only a single prophylactic dose of granisetron. Following the first additional dose of granisetron, around 87% of patients reported symptoms to be improved or resolved. Adverse experience reporting was higher in the comparator groups with somnolence and extrapyramidal reactions representing the most common events. Headache was the most commonly reported adverse experience in granisetron-treated patients. Granisetron has proved safe and effective in controlling chemotherapy-induced emesis and is more convenient to administer than conventional antiemetics.

Adolescent↗
PubMed1992

Fractionated chemotherapy--granisetron or conventional antiemetics? The Granisetron Study Group.

Two randomised single-blind comparative studies were carried out in patients receiving 5-day fractionated chemotherapy. The first which has been reported previously [1] compared granisetron (40 micrograms/kg) (n = 103) with alizapride (12 mg/kg) plus dexamethasone (8 mg) (n = 94) while the second compared granisetron (40 micrograms/kg) (n = 143) with metoclopramide (7 mg/kg) plus dexamethasone (12 mg) (n = 141). Granisetron, unlike alizapride or metoclopramide is a specific 5-HT3 antagonist. The percentage of complete responders (patients with no vomiting and no worse than mild nausea) over the 5-day treatment period was higher for granisetron than for alizapride/dexamethasone (54% vs. 42.7%) (P = 0.121) or for metoclopramide/dexamethasone (46.8% vs. 43.9%). The percentage of complete responders in the first 24 h was significantly higher for granisetron (90.3%) than for alizapride/dexamethasone (65.9%) (P less than 0.001) or for metoclopramide/dexamethasone (87.4% vs. 67.9% P less than 0.0001). Granisetron was also superior to both comparators in terms of the time to the first episode of moderate/severe nausea and to less than a complete response. Significantly fewer granisetron patients were withdrawn than in the alizapride/dexamethasone group (P = 0.017) or the metoclopramide/dexamethasone group (P less than 0.0001). In both studies more comparator patients were withdrawn due to lack of efficacy and adverse events. Significantly fewer granisetron patients experienced adverse events than in either the alizapride/dexamethasone group (47.6% vs. 61.7%, P = 0.047) or the metoclopramide/dexamethasone group (60.8% vs. 77.3% P = 0.003). Granisetron patients experienced a significantly higher occurrence of constipation in both studies (10.7% vs. 3.2% and 12.6% vs. 2.8%). Headache and fever were also more frequent in the granisetron group, while extrapyramidal effects, reported by 5.3% of the alizapride/dexamethsone group and 20.6% of the metoclopramide/dexamethasone group, were not reported in any granisetron patients.

Adult↗
PubMed1999

A double-blind randomized study comparing intramuscular (i.m.) granisetron with i.m. granisetron plus dexamethasone in the prevention of delayed emesis induced by cisplatin. The Italian Multicenter Study Group.

Granisetron has been shown to exert a beneficial therapeutic effect in the prophylaxis and treatment of acute nausea and vomiting due to chemotherapy. However, limited data regarding its efficacy in the prevention and treatment of delayed emesis are available. A total of 532 patients entered this multicenter double-blind study, aimed at comparing the efficacy and safety of intramuscular (i.m.) granisetron with that of i.m. granisetron plus dexamethasone. Complete response and total control were evaluated for 3 days following the first 24 h after cisplatin administration in two groups of patients: 262 treated with granisetron 3 mg i.m. daily (plus placebo), and 265 with granisetron at the same dose plus dexamethasone 8 and 4 mg twice daily. The rate of complete response was 58.0% in the granisetron group and 78.9% in the granisetron plus dexamethasone group over days 1-3 (p<0.01). Similarly, over the same period total control was 44.7% with granisetron alone and 65.3% with granisetron plus dexamethasone (p<0.01). Local and systemic tolerability of the i.m. therapy with granisetron were satisfactory. In conclusion, granisetron plus dexamethasone showed good protection against delayed emesis due to emetogenic chemotherapy.

Adult↗
PubMed1994

[Comparative trial of granisetron versus granisetron plus methylprednisolone for the prevention of nausea and vomiting induced by cancer chemotherapy].

Preclinical and clinical studies have demonstrated the effectiveness of granisetron in preventing emesis induced by antineoplastic chemotherapy. This comparative study was undertaken to investigate the efficacy and safety of granisetron (40 micrograms/kg) and granisetron plus methylprednisolone (MPL; 10 mg/kg). Sixty-eight patients were given granisetron 170 times and thirty-nine patients were given a combination of granisetron and MPL 81 times. Sixty-one patients received the treatment in crossover fashion during the same chemotherapy regimens. The emetic and nausea episodes were counted during the 24 hours following each chemotherapy treatment. Complete response, no emesis or less than two episodes, were obtained in 75.3% (128/170 times) of patients receiving granisetron alone compared to 85.2% (69/81 times) of patients receiving the combination of granisetron plus MPL. There were no significant differences in complete responses between the two groups, male and female, and each age group. However, 11 of eighteen patients receiving granisetron alone who responded mildly, if at all, with respect to nausea and vomiting, showed a complete or major response when MPL was added to granisetron. There were two patients who developed temporal paresthesia of the both hands as an adverse effect, but there was spontaneous recovery after 3 hours. Our data suggested that granisetron plus MPL was slightly more effective than granisetron alone and a safe antiemetic drug.

Adolescent↗
PubMedDate not supplied

Comparison of granisetron with granisetron plus droperidol combination prophylaxis in post-operative nausea and vomiting after laparoscopic cholecystectomy.

The aim of this study was to evaluate the effects of granisetron and granisetron plus droperidol combination therapy on post-operative nausea and vomiting (PONV) in 60 patients who had undergone elective laparoscopic cholecystectomy. Induction of anaesthesia was achieved using 5 mg/kg thiopentone, 2 micrograms/kg fentanyl and 0.5 mg/kg atracurium, and anaesthesia was maintained with 2-2.5% sevoflurane. The patients were randomly assigned to two groups: group G (granisetron) (n = 30) patients received 3 mg granisetron and group GD (granisetron plus droperidol) (n = 30) patients received 3 mg granisetron and 1.25 mg droperidol shortly before the induction of anaesthesia. PONV incidence was recorded post-operatively at 15 min, 30 min, 60 min, 2 h, 4 h, 12 h and 24 h. While PONV prophylaxis provided almost complete emetic control in patients who received the granisetron plus droperidol combination, patients who received granisetron prophylaxis alone experienced PONV more frequently at 30 min and 60 min post-operatively. We conclude that addition of a low dose of droperidol to granisetron prophylaxis is more effective than granisetron prophylaxis alone for successful control of PONV.

Adult↗
PubMed1993

The antiemetic efficacy and safety of granisetron compared with metoclopramide plus dexamethasone in patients receiving fractionated chemotherapy over 5 days. The Granisetron Study Group.

The antiemetic efficacy and safety of granisetron (40 micrograms/kg), a selective and potent 5-hydroxytryptamine (serotonin) antagonist, was compared with that of metoclopramide (7 mg/kg) plus dexamethasone (12 mg) in patients receiving fractionated chemotherapy. Patients receiving cisplatin at doses of at least 15 mg/m2 or etoposide at least 120 mg/m2 or ifosfamide at least 1.2 g/m2 on each of 5 consecutive days were eligible. A total of 143 patients received granisetron and 141 received the comparator regimen. The 5-day complete response rate (no vomiting, no worse than mild nausea) for granisetron (46.8%) was equivalent to that for metoclopramide plus dexamethasone (43.9%). The overall 5-day response profile was superior for granisetron (P = 0.013) because of fewer failures in this group. The overall incidence of adverse experiences was significantly lower in the granisetron group (60.8% versus 77.3%, P = 0.003). Headache and constipation, more prevalent in the granisetron group, are recognized side-effects of serotonin antagonists. Extrapyramidal syndrome, not seen in any granisetron patients, occurred in 20.6% of comparator patients (P < 0.0001). The majority of granisetron patients only required a single prophylactic dose of the drug on each treatment day (at least 82%). In conclusion, granisetron showed at least equivalent efficacy to metoclopramide plus dexamethasone in patients receiving 5-day fractionated chemotherapy. In addition it offered a simple and convenient dosing regimen and a safer side-effect profile.

Antiemetics↗
PubMed1994

A double-blind, randomised, crossover comparison of granisetron and ondansetron in 5-day fractionated chemotherapy: assessment of efficacy, safety and patient preference. The Granisetron Study Group.

We report the first double-blind, randomised, crossover study comparing granisetron and ondansetron as antiemetics in cancer chemotherapy. Patients receiving two cycles of identical chemotherapy fractionated over 5 days were given either granisetron (3 mg/day) or ondansetron (24 mg/day) on each day of chemotherapy, using a double-dummy technique to preserve study blindness. Patients then crossed over to the other therapy. 309 patients (237 male) completed the crossover: 260 received cisplatin (mean dose 19.2 mg/m2/day) and 49 received ifosfamide (mean dose 1415 mg/m2/day). Primary efficacy variables were prospectively defined as complete response (no vomiting and mild or absent nausea) over 5 days, and patient preference. Both agents achieved good control of emetic symptoms with 5-day complete response rates of 44.0% on granisetron and 39.8% on ondansetron [95% confidence interval (CI) for odds ratio 0.8, 1.9]. Complete response rates were very similar in patients receiving either cisplatin (40.8% granisetron, 37.6% ondansetron) or ifosfamide (61.2% granisetron, 51.0% ondansetron). There was a statistically significant difference in patient preference in favour of granisetron, 105 patients preferred granisetron, 79 preferred ondansetron, 121 had no preference (P = 0.048: 95% CI for odds ratio 1.00, 1.84). Single daily doses of granisetron (3 mg/day) appeared similarly effective and well tolerated to three daily doses of ondansetron (8 mg three times daily) in prevention of emesis induced by 5-day fractionated chemotherapy, however, significantly more patients preferred granisetron.

Adolescent↗
PubMed2003

Comparison of granisetron and granisetron plus dexamethasone for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomies are associated with an appreciably high rate of postoperative nausea and vomiting (PONV). This study was designed to compare the effectiveness of granisetron plus dexamethasone with granisetron alone for the prevention of postoperative nausea and vomiting in patients after laparoscopic cholecystectomy. METHODS: In a randomized, double-blind study, 120 patients of both sexes received granisetron 40 micro g kg-1 alone or granisetron 40 micro g kg-1 plus dexamethasone 8 mg (n=60 of each) intravenously immediately before induction of anesthesia. Perioperative anesthetic care was standardized in all patients. Patients were then observed for 24 h after administration of the study drug. RESULTS: A complete response (defined as no PONV and no need for another rescue antiemetic) was achieved in 83% of the patients given granisetron and in 95% of the patients given granisetron plus dexamethasone (P<0.05). The overall cumulative incidences (0-24 h) of PONV were 11 (18.3%) in the granisetron and three (5%) in the combination group. No difference in adverse events were observed in any of the groups. CONCLUSION: The combination (granisetron plus dexamethasone) further increases the chance of complete response than granisetron alone. Therefore, the combination might be considered clinically relevant in a high risk setting.

Adult↗
PubMed1995

Comparative clinical trial of granisetron and ondansetron in the prophylaxis of cisplatin-induced emesis. The Granisetron Study Group.

PURPOSE: To compare the efficacy and safety of granisetron and ondansetron, serotonin (5-HT3) receptor antagonists shown to be effective in the prevention of chemotherapy-induced emesis. PATIENTS AND METHODS: In a double-blind, randomized, stratified, parallel-group study, the efficacy and safety of granisetron and ondansetron were compared in 987 chemotherapy-naive patients who received cisplatin in doses > or = 60 mg/m2. Granisetron was administered as a single dose of 10 or 40 micrograms/kg before the start of chemotherapy. Ondansetron was administered in doses of 0.15 mg/kg before and 4 and 8 hours after the start of chemotherapy. The three treatment groups were well-matched with respect to demographic characteristics and the dose of cisplatin administered. RESULTS: For all evaluations, single doses of granisetron 10 or 40 micrograms/kg were as effective as three 0.15-mg/kg doses of ondansetron. Total control (no vomiting, no retching, no nausea, and no use of rescue) was attained by 38%, 41%, and 39% of all patients who received granisetron 10 microgram/kg, granisetron 40 micrograms/kg, and ondansetron, respectively. No vomiting or retching and no use of rescue antiemetics were reported in 47%, 48%, and 51% of patients who received granisetron 10 micrograms/kg, granisetron 40 micrograms/kg, and ondansetron, respectively; no nausea and no use of rescue antiemetics were reported in 39%, 42%, and 40% of patients, respectively. CONCLUSION: All three treatment regimens were well-tolerated. The results of this study indicate that a single dose of granisetron 10 or 40 micrograms/kg is as effective as three doses of ondansetron 0.15 mg/kg in the prevention of nausea and vomiting induced by cisplatin chemotherapy.

Adult↗
PubMed1997

[A comparative study of the effects of granisetron alone and a combination of granisetron plus steroids on CDDP-based combination chemotherapy-induced emesis--outcomes of a multicenter randomized comparative study using the central registration method. Nara Medical University Kytril Study Group].

The present investigation was conducted to examine the effects of granisetron alone and a combination of granisetron plus steroids on CDDP-based combination chemotherapy-induced emesis by multi-institutional randomized comparative trial using a central registration method. A total of 62 patients with urological cancer enrolled this study were randomized into two groups: granisetron (40 micrograms/kg) only group and granisetron (40 micrograms/kg) plus steroids (500 mg of methylprednisolone or 8 mg of dexamethasone) group. There were 31 patients eligible in the granisetron only group and 28 in the combination group. The same anti-emetic treatments were given in the recycling courses of chemotherapeutic regimens. Therefore, eligible patients of the second and the third cycle numbered 31 (17 in the granisetron only group, 14 in the combination group) and 21 (11 in the granisetron only group and 10 in the combination group). Significant inhibition of acute emesis in combination group was observed when compared with the granisetron only group in each cycle. Delayed emesis was also significantly inhibited in the combination group on Day 2 and 3 of the first cycle and on Day 2 of the second and third cycle. In addition, appetite loss was significantly reduced in the combination group on Day 2 and 3 of the first and second cycle. No adverse events were seen in either group. These results suggested that a combination of granisetron and steroids was useful for preventing CDDP-based combination chemotherapy-induced emesis.

Adult↗
PubMed1993

Clinical studies with granisetron, a new 5-HT3 receptor antagonist for the treatment of cancer chemotherapy-induced emesis. The Granisetron Study Group.

Granisetron (BRL 43694A) is a novel, selective 5-hydroxytryptamine-3 (5-HT3) receptor antagonist developed for the prophylaxis and treatment of cytostatic drug-induced emesis. After a brief review of the preclinical evaluation of granisetron the clinical findings with this novel compound are summarised. From the data of large randomised trials one can conclude that granisetron is an active antiemetic, both as a prophylactic and an intervention agent, to an extent which is superior or at least equal to the best available antiemetic combination regimens, having a major efficacy ranging from 74 to 92%. Granisetron may be given as a single, 5-min infusion before chemotherapy and is thus more convenient to administer than many antiemetic regimens. The adverse event profile of granisetron is favourable with a wide therapeutic margin. The only consistent side-effects attributable to granisetron are headache in about 14% of the patients and constipation in about 4% of the patients. Headache induced by granisetron was generally mild and resolved spontaneously or was promptly relieved with standard analgesics. No extrapyramidal side-effects were observed with granisetron.

Adult↗
PubMed1993

The control of acute cisplatin-induced emesis--a comparative study of granisetron and a combination regimen of high-dose metoclopramide and dexamethasone. Granisetron Study Group.

The anti-emetic efficacy and safety of granisetron, a highly selective and potent 5-HT3 receptor antagonist, was compared with that of high-dose metoclopramide plus dexamethasone in 281 patients due to receive single-day cisplatin chemotherapy (> or = 49 mg m-2). In this single-blind, multicentre study, granisetron (40 micrograms kg-1) was administered as a single prophylactic 5-min infusion. Dexamethasone (12 mg) was administered as a 30-min infusion followed by a loading dose of 3 mg kg-1 metoclopramide. A maintenance dose of metoclopramide 4 mg kg-1 was then infused over 8 h. A single prophylactic dose of granisetron was as effective as the combination regimen in the prevention of cisplatin-induced emesis. Of 143 granisetron-treated patients, 100 (70%) were complete responders (no vomiting and no or only mild nausea) compared with 93/138 (67%) patients who received the comparator regimen. Twenty-three percent of granisetron-treated patients experienced one of more adverse events compared with 33% of patients in the comparator group. No extrapyramidal reactions were reported in the granisetron group compared with 13 in comparator-treated patients (8%). This difference was significant (P < 0.05). The commonest adverse event in the granisetron group, headache (9.8%) described by the majority of patients as mild, was significantly higher than that reported in the comparator group (3% P = 0.02). Granisetron appears to be a safe and effective agent which can be used as a single agent for the prophylaxis of cisplatin-induced emesis. The simplicity of administration, a single 5-min infusion prior to chemotherapy, and the lack of somnolence or extrapyramidal reactions offer clear advantages over the comparator combination regimen.

Blood Pressure↗
PubMed1996

[Comparison of clinical effects between granisetron alone and combination of granisetron and methylprednisolone against the nausea and vomiting induced by CDDP chemotherapy--comparative study by the cross-over trial. University of Tsukuba Antiemetics Study Group].

A cross-over clinical trial was carried out to compare the antiemetic effect and safety between granisetron alone (40 micrograms/kg) and the combination of granisetron and methylprednisolone (MP: 10 mg/kg) in urological cancer patients treated with cisplatin. Forty-eight courses were given with granisetron alone and 47 courses with both granisetron and MP. The antiemetic effect of nausea and vomiting was evaluated in the acute emetic phase. during the 24 hours following the CDDP administration, and in the delayed emetic phase, 2 to 7 days after the administration. Combination therapy of granisetron and MP demonstrated a greater antiemetic effect during the 72 hours following the CDDP administration than by granisetron alone. But there was no significant difference in antiemetic effect between combination therapy and granisetron alone after the 3rd day. Combination therapy also demonstrated more efficacy in complete antiemetic effect, with no emesis and less than moderate nausea, than by granisetron alone. Both treatments showed no side effects and were safe.

Aged↗
PubMed1996

[Comparative trial of granisetron alone and granisetron plus methylprednisolone for prevention of nausea and vomiting during cancer chemotherapy].

A crossover clinical trial between granisetron alone and granisetron combined with methylprednisolone (MPL) was undertaken for the prevention of nausea and vomiting during chemotherapy, including cisplatin, in 12 patients with advanced primary and metastatic lung cancer. The antiemetic effect was obtained in 91.7% (11/12 cases) of patients receiving granisetron alone compared to 100% (12/12 cases) of patients receiving the combination of granisetron plus MPL. Complete control of anorexia was achieved in 91.6% (11/12 cases) of patients receiving the combination compared to 58.3% (7/12 cases) of patients receiving granisetron alone. Moreover there was a significant improvement of delayed clinical symptoms including nausea, vomiting, and anorexia in the patients receiving the combination of granisetron plus MPL. Our data suggest that the antiemetic effect of the combination of granisetron plus MPL is superior to granisetron alone in patients receiving cancer chemotherapy.

Adult↗
PubMed1999

[Comparative trial of oral granisetron and intravenous ondansetron in patients receiving chemotherapy for breast cancer. Study Group of Granisetron].

This multicentric randomized trial compared two strategies in the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy in patients with breast cancer. The antiemetic efficacy and side effects of oral granisetron, followed by metoclopramide, were compared to those of intravenous (IV) ondansetron followed by oral ondansetron. 198 chemonaive patients with breast cancer, treated with a moderately emetogenic chemotherapy, were randomly assigned to receive either oral granisetron 1 mg twice a day on day 1, followed by metoclopramide, 60 mg on day 2 and 3, or ondansetron, 8 mg IV on day 1, followed by ondansetron 8 mg tablet twice a day on day 2 and 3. Both treatments have shown similar control of acute emesis: complete response was achieved in 71% of granisetron group and 66% of ondansetron, and total response in respectively 49% and 53%. However, granisetron plus metoclopramide showed a trend towards better efficacy than oral ondansetron in the prevention of delayed emesis. Furthermore, during the overall study period (day 1 to 5), the percentage of complete responses in the group receiving oral granisetron followed by oral metoclopramide was significantly higher than in the group receiving ondansetron (53% versus 37%; p = 0.022). In conclusion, oral granisetron has shown similar efficacy as IV ondansetron in the prevention of acute emesis induced by moderately emetogenic chemotherapy. Oral granisetron followed by metoclopramide seems more efficient than IV plus oral ondansetron in the prevention of delayed emesis.

Administration, Oral↗
PubMed1990

A comparative study of the use of granisetron, a selective 5-HT3 antagonist, versus a standard anti-emetic regimen of chlorpromazine plus dexamethasone in the treatment of cytostatic-induced emesis. The Granisetron Study Group.

Patients with cancer were randomized in single-blind fashion to receive either granisetron (n = 114) or a conventional anti-emetic combination of chlorpromazine and dexamethasone (n = 113) as prophylactic agents against the nausea and vomiting induced by a number of designated cytostatic drugs. In the first 24 h, 70% of patients in the granisetron group remained free from vomiting and had no, or only mild nausea compared with 49% of patients in the comparator group, a significant improvement over the conventional anti-emetic (P = 0.0013). Significantly fewer adverse events were reported in the granisetron group (P less than 0.05) and treatment did not result in the somnolence reported by patients receiving chlorpromazine plus dexamethasone (P less than 0.05). In the conventional treatment group, initial infusions were maintained with oral chlorpromazine at 4-6 h intervals in the first 24 h. Ten per cent of these patients received alternative, rescue anti-emetics during this period. In the granisetron group, 70% of patients received only a single prophylactic dose of 40 micrograms/kg granisetron throughout the 7-day period. During the first 24 h, 20% of patients in the granisetron group received up to two additional 40 micrograms/kg doses of granisetron and 6% received rescue anti-emetics.

Adolescent↗