title: A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting.
abstract: OBJECTIVE
  This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).
  
  
  METHODS
  Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy). The pharmacokinetics and pharmacodynamics using RINVR were evaluated.
  
  
  RESULTS
  Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively. T max (h), C max (ng/mL), and AUClast (ng·h/mL) were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%), two patients (14.3%), and one (5.6%) patient and a delayed CINV on day 7 was found in eight (47%), three (21.4%), and five (27.8%) patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group) and also showed the tendency for decreasing moderate-to-severe CINV.
  
  
  CONCLUSIONS
  This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Ka-Rham
authors.initials: KR
authors.lastname: Kim
authors.affiliation: Division of Clinical Pharmacology, Chonnam National University Hospital, Gwangju 519-763, Republic of Korea.
authors.forename: Gaeun
authors.initials: G
authors.lastname: Kang
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Myung-Seo
authors.initials: MS
authors.lastname: Ki
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Hyun-Jeong
authors.initials: HJ
authors.lastname: Shim
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Jun-Eul
authors.initials: JE
authors.lastname: Hwang
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Woo-Kyun
authors.initials: WK
authors.lastname: Bae
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Ik-Joo
authors.initials: IJ
authors.lastname: Chung
authors.affiliation: Division of Clinical Pharmacology, Chonnam National University Hospital, Gwangju 519-763, Republic of Korea ; Department of Pharmacology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Jong-Keun
authors.initials: JK
authors.lastname: Kim
authors.affiliation: Department of Anesthesiology and Pain Medicine, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Seongwook
authors.initials: S
authors.lastname: Jeong
authors.affiliation: Department of Hemato-Oncology, Chonnam National University Medical School, Gwangju 519-763, Republic of Korea.
authors.forename: Sang-Hee
authors.initials: SH
authors.lastname: Cho
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D001562:Benzimidazoles / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000188:drug therapy*; D010865:Pilot Projects; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D001562:Benzimidazoles; C071315:ramosetron