Ondansetron + dexamethasone vs metoclopramide + dexamethasone + diphenhydramine in prevention of cisplatin-induced emesis. Italian Group For Antiemetic Research.
Ondansetron, a selective serotonin-receptor antagonist, is an effective antiemetic for patients receiving high-dose cisplatin chemotherapy. However, no comparison has been made between a combination of a serotonin antagonist and dexamethasone, which also has antiemetic properties, with currently available antiemetic regimens. 289 consecutive cancer patients receiving cisplatin chemotherapy (much greater than 50 mg/m2) were randomised to receive one of the following intravenous antiemetic regimens: ondansetron 0.15 mg/kg, before and after cisplatin, + dexamethasone 20 mg before cisplatin (treatment A) or metoclopramide 3 mg/kg, before and after cisplatin, + dexamethasone + diphenhydramine 50 mg before cisplatin (treatment B). From day 2 to day 4, all patients received oral metoclopramide and intramuscular dexamethasone. 267 patients (136 receiving treatment A and 131 treatment (B) were available for analysis. Complete protection against emesis was achieved in 107 (78.7%) and 78 (59.5%) patients, respectively (p less than 0.002). Complete protection was also significantly superior for treatment A on day 2 (83.9% vs 68.0%; p less than 0.006). Complete protection from acute nausea (first 24 h) was achieved in 105 patients (77.2%) with treatment A and in 86 (65.6%) with treatment B (p less than 0.051); complete protection from nausea and emesis was achieved in 94 (69.1%) patients and 66 (50.4%), respectively (p less than 0.003). Patients receiving treatment B noted significantly more sedation than patients receiving treatment A (11.8% vs 2.1%; p less than 0.005). Extrapyramidal reactions were present only with treatment B (2.7%). Ondansetron + dexamethasone is more effective and better tolerated than metoclopramide + dexamethasone + diphenhydramine in the prevention of cisplatin-induced nausea and emesis.
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects*; D002985:Clinical Protocols / Q000592:standards; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004155:Diphenhydramine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D007273:Injections, Intramuscular; D007558:Italy / Q000453:epidemiology; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D017294:Ondansetron; D011446:Prospective Studies; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy* / Q000453:epidemiology
D000932:Antiemetics; D007093:Imidazoles; D017294:Ondansetron; D003907:Dexamethasone; D004155:Diphenhydramine; D008787:Metoclopramide; D002945:Cisplatin