Efficacy and tolerability of cancer pain management with controlled-release oxycodone tablets in opioid-naive cancer pain patients, starting with 5 mg tablets.
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.
Koizumi
Wasaburo
W
Department of Gastroenterolgy, East Hospital, Kitasato University, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
Toma
Hiroshi
H
Watanabe
Ken-ichi
K
Katayama
Kanji
K
Kawahara
Masaaki
M
Matsui
Kaoru
K
Takiuchi
Hiroya
H
Yoshino
Kunitoshi
K
Araki
Nobuhito
N
Kodama
Ken
K
Kimura
Hideyuki
H
Kono
Ichiro
I
Hasegawa
Hiroyasu
H
Hatanaka
Kaoru
K
Hiraga
Kazuaki
K
Takeda
Fumikazu
F
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
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D013607:Tablets; D010098:Oxycodone