title: Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: a double-blind, randomized, non-inferiority trial.
abstract: OBJECTIVE
  A single 3 mg or 40 μg/kg intravenous dose of granisetron combined with dexamethasone is routinely used in several countries, although the antiemetic guidelines have recommended granisetron at the dose of 1 mg or 10 μg/kg. A randomized, multicenter trial was conducted to determine the optimal intravenous granisetron dose, 1 or 3 mg, in cancer patients receiving emetogenic chemotherapy.
  
  
  METHODS
  We enrolled 365 patients and randomly assigned them to receive intravenous granisetron 3 mg (3-mg group) or 1 mg (1-mg group), combined with dexamethasone at an adequate dose fixed as per the emetic risk category. The primary end point was the proportion of patients with a complete response during the first 24 h after chemotherapy.
  
  
  RESULTS
  The study demonstrated that 1 mg of granisetron was not inferior in effect to 3 mg. For the primary end point, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p < 0.01 for non-inferiority).
  
  
  CONCLUSIONS
  This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone. Therefore, 1-mg dose of intravenous granisetron should be the recommended prophylactic regimen for the prevention of acute emesis.
authors: Department of Clinical Pharmacology & Genetics, School of Pharmaceutical Sciences, University of Shizuoka, Suruga-ku, Shizuoka, Japan.
authors: Daiki
authors: D
authors: Tsuji
authors: Yong-Il
authors: YI
authors: Kim
authors: Keisei
authors: K
authors: Taku
authors: Shigeru
authors: S
authors: Nakagaki
authors: Yoshito
authors: Y
authors: Ikematsu
authors: Hiromi
authors: H
authors: Tsubota
authors: Masato
authors: M
authors: Maeda
authors: Naoya
authors: N
authors: Hashimoto
authors: Masayuki
authors: M
authors: Kimura
authors: Takashi
authors: T
authors: Daimon
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