TY - JOUR
T1 - Oxycodone controlled-release as first-choice therapy for moderate-to-severe cancer pain in Italian patients
T2 - Results of an open-label, multicentre, observational study
AU - Silvestri, Barbara
AU - Bandieri, Elena
AU - Del Prete, Salvatore
AU - Ianniello, Giovanni Pietro
AU - Micheletto, Giuseppe
AU - Dambrosio, Mario
AU - Sabbatini, Giovanni
AU - Endrizzi, Luigi
AU - Marra, Alessandro
AU - Aitini, Enrico
AU - Calorio, Angioletta
AU - Garetto, Ferdinando
AU - Nastasi, Giuseppe
AU - Piantedosi, Francovito
AU - Sidoti, Vincenzo
AU - Spanu, Piergiorgio
PY - 2008
Y1 - 2008
N2 - 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.
AB - 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.
KW - Cancer pain
KW - Opioid analgesics, therapeutic use
KW - Oxycodone, therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=44949131642&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=44949131642&partnerID=8YFLogxK
U2 - 10.2165/00044011-200828070-00001
DO - 10.2165/00044011-200828070-00001
M3 - Article
C2 - 18544000
AN - SCOPUS:44949131642
SN - 1173-2563
VL - 28
SP - 399
EP - 407
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
IS - 7
ER -