title: Long-term administration of controlled-release oxycodone tablets for the treatment of cancer pain.
abstract: We conducted a study of the safety of controlled-release (CR) oxycodone tablets (OxyContin Tablets) administered chronically to patients with cancer-related pain in a usual clinical setting. These patients had participated in 1 of 2 double-blind, active-control studies. Our study was an open, 3-month treatment study that included 87 patients. Patients received CR oxycodone tablets every 12 hr in a manner that reflected typical clinical practice. Supplemental immediate-release (IR) oxycodone was available PRN for breakthrough pain. Patients recorded medication use, adverse events, and evaluations of pain intensity and acceptability of therapy in a daily diary. Forty-four patients (51%) completed all 12 weeks of study; 43 patients (49%) discontinued participation. At baseline and throughout the study period, the overall mean pain-intensity score was slight to moderate. A comparison of initial and final doses showed a significant but modest increase in total daily CR oxycodone dose. An increase or decrease in titration of the oxycodone dose occurred for 66 patients (84%) at least once during the 12-week study period, primarily for increased pain. Forty-four patients (56%) did not undergo dose titration when the latter was indicated. Half of the patients used IR oxycodone rescue almost daily; the mean number of rescue doses per day was 1.5. Despite stable pain control and an increasing total daily CR oxycodone dose, the percentage of patients reporting common opioid-related adverse events decreased over the course of the study. CR oxycodone tablets administered every 12 hr were successfully used to manage cancer pain over a 12-week period. Importantly, side effects diminished over time without a concomitant change in efficacy.
authors.affiliation: ProHealth Care Associates, LLP Lake Success, New York, USA.
authors.forename: M L
authors.initials: ML
authors.lastname: Citron
authors.forename: R
authors.initials: R
authors.lastname: Kaplan
authors.forename: W C
authors.initials: WC
authors.lastname: Parris
authors.forename: M K
authors.initials: MK
authors.lastname: Croghan
authors.forename: L H
authors.initials: LH
authors.lastname: Herbst
authors.forename: R J
authors.initials: RJ
authors.lastname: Rosenbluth
authors.forename: R F
authors.initials: RF
authors.lastname: Reder
authors.forename: N S
authors.initials: NS
authors.lastname: Slagle
authors.forename: B J
authors.initials: BJ
authors.lastname: Buckley
authors.forename: R F
authors.initials: RF
authors.lastname: Kaiko
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy*; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy*; D010342:Patient Acceptance of Health Care; D013997:Time Factors
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010098:Oxycodone