当前位置： SCI文献检索 > CLINICAL DRUG INVESTIGATION期刊下所有文献 > 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.

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 > or =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.

journal_name

Clin Drug Investig

journal_title

Clinical drug investigation

authors

Silvestri B,Bandieri E,Del Prete S,Ianniello GP,Micheletto G,Dambrosio M,Sabbatini G,Endrizzi L,Marra A,Aitini E,Calorio A,Garetto F,Nastasi G,Piantedosi F,Sidoti V,Spanu P

doi

10.2165/00044011-200828070-00001

subject

Has Abstract

pub_date

2008-01-01 00:00:00

pages

399-407

issue

eissn

1173-2563

issn

1179-1918

pii

2871

journal_volume

pub_type

临床试验,杂志文章,多中心研究

在线工具

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