Oxycodone controlled-release as first-choice therapy for moderate-to-severe cancer pain in Italian patients: Results of an open-label, multicentre, observational study

Barbara Silvestri, Elena Bandieri, Salvatore Del Prete, Giovanni Pietro Ianniello, Giuseppe Micheletto, Mario Dambrosio, Giovanni Sabbatini, Luigi Endrizzi, Alessandro Marra, Enrico Aitini, Angioletta Calorio, Ferdinando Garetto, Giuseppe Nastasi, Francovito Piantedosi, Vincenzo Sidoti, Piergiorgio Spanu

Research output: Contribution to journalArticle

Abstract

Background and objectives: Cancer pain affects patients at all stages of the disease and there are clear guidelines for its management. Morphine is considered the first-choice strong opioid in the treatment of moderate-to-severe pain; however, numerous studies have shown that oxycodone controlled-release (CR) has a similar efficacy and safety profile. The purpose of this study was to evaluate the efficacy and tolerability of oxycodone CR as a first-line strong opioid for the treatment of moderate-to-severe pain in Italian cancer patients. Methods: This was a prospective, open-label, multicentre, observational trial carried out at 15 locations across Italy. Patients with a referral for cancer-related pain of ≥5 on a 10-point numerical rating scale were enrolled. Patients were treated with oral oxycodone CR and monitored for 21 days. Dosage was individualized for each patient and up-titrated until effective pain control was achieved. Pain, adverse events and quality-of-life scores were assessed throughout the study. Results: 390 patients (174 females and 216 males) with a mean age of 66 ± 11 years were evaluated. The average daily dose ranged from 22.84 on day 1 to 40 mg/day on day 21. Pain intensity (assessed on a 10-point numerical rating scale) decreased significantly within 1 day of treatment commencement (p = 0.00001) and continued to decrease throughout the study period (from a mean 7.22 at baseline to a mean 2.11 points on day 21). Adverse events were mild to moderate in intensity and consisted of common opioid-related events. Ten patients (2.6%) discontinued the study because of adverse events and four (1%) because of uncontrolled pain. All aspects of activities of daily life assessed were improved by study end. Conclusions: Oxycodone CR is efficacious and well tolerated as a first-line strong opioid for the treatment of moderate-to-severe cancer-related pain in Italian patients.

Original languageEnglish
Pages (from-to)399-407
Number of pages9
JournalClinical Drug Investigation
Volume28
Issue number7
DOIs
Publication statusPublished - 2008

Keywords

  • Cancer pain
  • Opioid analgesics, therapeutic use
  • Oxycodone, therapeutic use

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

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    Silvestri, B., Bandieri, E., Del Prete, S., Ianniello, G. P., Micheletto, G., Dambrosio, M., Sabbatini, G., Endrizzi, L., Marra, A., Aitini, E., Calorio, A., Garetto, F., Nastasi, G., Piantedosi, F., Sidoti, V., & Spanu, P. (2008). Oxycodone controlled-release as first-choice therapy for moderate-to-severe cancer pain in Italian patients: Results of an open-label, multicentre, observational study. Clinical Drug Investigation, 28(7), 399-407. https://doi.org/10.2165/00044011-200828070-00001