Oxycodone Controlled-Release as First-Choice Therapy for Moderate-to-Severe Cancer Pain in Italian Patients: Results of an Open-Label, Multicentre, Observational Study

Oxycodone Controlled-Release as First-Choice Therapy for Moderate-to-Severe Cancer Pain in Italian Patients Results of an Open-Label, Multicentre, Observational Study

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-re...

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Bibliographic Details
Published in:Clinical drug investigation Vol. 28; no. 7; pp. 399 - 407
Main Authors: Silvestri, Barbara, Bandieri, Elena, Del Prete, Salvatore, Ianniello, Giovanni Pietro, Micheletto, Giuseppe, Dambrosio, Mario, Sabbatini, Giovanni, Endrizzi, Luigi, Marra, Alessandro, Aitini, Enrico, Calorio, Angioletta, Garetto, Ferdinando, Nastasi, Giuseppe, Piantedosi, Francovito, Sidoti, Vincenzo, Spanu, Piergiorgio
Format: Journal Article
Language:English
Published: Cham Springer International Publishing 01-01-2008
Wolters Kluwer Health, Inc
Springer Nature B.V
Subjects:
Adult
Aged
Aged, 80 and over
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - adverse effects
Analgesics, Opioid - therapeutic use
Delayed-Action Preparations
Dose-Response Relationship, Drug
Female
Humans
Internal Medicine
Italy - epidemiology
Male
Medicine
Medicine & Public Health
Middle Aged
Neoplasms - complications
Original Research Article
Oxycodone - administration & dosage
Oxycodone - adverse effects
Oxycodone - therapeutic use
Pain - drug therapy
Pain - etiology
Pain Measurement
Pharmacology/Toxicology
Pharmacotherapy
Prospective Studies
Quality of Life
Severity of Illness Index
Italy
Numerical Rating Scale
Morphine
Oxycodone
Cancer Pain
Strong Opioid
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Summary: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.
ISSN:1173-2563
1179-1918
DOI:10.2165/00044011-200828070-00001