Comparison of ramosetron and granisetron for the prevention of acute and delayed emesis in Cisplatin-based chemotherapy: a randomized controlled trial.
OBJECTIVE
A clinical study of ramosetron was carried out to evaluate its efficacy in preventing both acute and delayed emesis in cisplatin-based chemotherapy by using a double-blind method with granisetron as the comparative drug.


METHODS
Cisplatin at a dose of > or =70 mg/m(2) was administered as a single intravenous (i.v.) infusion over 4 h. Patients were randomly assigned to receive either ramosetron (0.3 mg i.v. bolus 30 min before cisplatin on Day 1 and a 0.1 mg tablet in the morning for Days 2 to 5 after completion of chemotherapy; n = 36) or granisetron (3 mg i.v. infusion 30 min before cisplatin on Day 1 and a 1 mg tablet in the morning for Days 2 to 5 after completion of chemotherapy; n = 37). The observation period started with the initiation of chemotherapy (0 h) and continued for 24 h after completion of the chemotherapy for acute emesis, and on Days 2 to 5 for delayed nausea and vomiting.


RESULTS
A total of 73 patients were eligible for evaluation, with 36 patients in the ramosetron group and 37 in the granisetron group. The efficacy of both drugs was analyzed in terms of the degree of achievement in each day of treatment. Ramosetron was as effective as granisetron in preventing nausea and vomiting (both acute and delayed emesis). The two drugs had a similar safety profile and adverse events were generally mild and transient.


CONCLUSIONS
Ramosetron is effective and safe for the control of acute and delayed emesis induced by cisplatin.
Cheirsilpa
Arkom
A
Division of Medical Oncology, National Cancer Institute, 268/1 Rama 6th Road, Rajthevi, Bangkok 10400, Thailand. silpa@health.moph.go.th
Sinthusake
Tanadej
T
Songsakkaesorn
Apinya
A
Visawaprasit
Somchit
S
Chulaka
Kemachit
K
Changkuingdee
Nunchaporn
N
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D023381:Endpoint Determination; D005260:Female; D017829:Granisetron / Q000009:adverse effects / Q000627:therapeutic use*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D014840:Vomiting, Anticipatory / Q000517:prevention & control*
D000932:Antiemetics; D001562:Benzimidazoles; D002945:Cisplatin; D017829:Granisetron; C071315:ramosetron