title: Efficacy and tolerability of cancer pain management with controlled-release oxycodone tablets in opioid-naive cancer pain patients, starting with 5 mg tablets.
abstract: BACKGROUND
  We conducted an open-label, dose titration study to assess the efficacy and tolerability of controlled-release oxycodone in the therapy of cancer pain management, starting with a newly developed 5 mg tablet every 12 h.
  
  
  METHODS
  Twenty-two Japanese cancer patients with pain who had not been taking opioid analgesics over the previous 2 weeks were enrolled. The length of time and the dose needed to attain stable and adequate pain control were evaluated in addition to the assessment of analgesic efficacy and safety during the study period.
  
  
  RESULTS
  Eighteen patients in the efficacy population (18 out of 20, 90%) attained stable, adequate pain control. Two-thirds of the patients attained stable, adequate pain control without any dose titration. The mean length of time was 1.2 days. In these patients, the pain was significantly reduced in intensity, even at 1 h after the initial dose intake. Fifteen patients (68%) reported at least one side effect, but only one patient had to withdraw from the study because of a side effect.
  
  
  CONCLUSIONS
  The results suggest that controlled-release oxycodone tablets offered stable and adequate pain control within a short period of time in most Japanese cancer patients who have not been taking opioid analgesics, and could be effectively titrated against pain from a starting dose of 5 mg every 12 h. This indicates that a lower strength controlled-release oxycodone formulation may make it possible to start and titrate the dose more appropriately and carefully in patients who are sensitive to opioid analgesics.
authors.affiliation: Department of Gastroenterolgy, East Hospital, Kitasato University, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Toma
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Watanabe
authors.forename: Kanji
authors.initials: K
authors.lastname: Katayama
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kawahara
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Hiroya
authors.initials: H
authors.lastname: Takiuchi
authors.forename: Kunitoshi
authors.initials: K
authors.lastname: Yoshino
authors.forename: Nobuhito
authors.initials: N
authors.lastname: Araki
authors.forename: Ken
authors.initials: K
authors.lastname: Kodama
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Kimura
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kono
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Hasegawa
authors.forename: Kaoru
authors.initials: K
authors.lastname: Hatanaka
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Hiraga
authors.forename: Fumikazu
authors.initials: F
authors.lastname: Takeda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000503:physiopathology*; D010098:Oxycodone / Q000008:administration & dosage*; D010147:Pain Measurement / Q000379:methods*; D010148:Intractable Pain / Q000188:drug therapy*; D010342:Patient Acceptance of Health Care; D013274:Stomach Neoplasms / Q000503:physiopathology; D013607:Tablets; D017186:Titrimetry
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D013607:Tablets; D010098:Oxycodone