Abstract | BACKGROUND: OBJECTIVES: A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain. METHODS: OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg⁄day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients' and investigators' global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID). RESULTS: A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment. CONCLUSIONS:
|
Authors | Eun-Kee Song, Hyunjeong Shim, Hye-Suk Han, DerSheng Sun, Soon-Il Lee, Myung Hee Kang, KyuTaek Lee, DoYeun Cho, In Sung Cho, Suk Young Park, Samyong Kim, Chang-Yeol Yim |
Journal | Pain research & management
(Pain Res Manag)
2015 Nov-Dec
Vol. 20
Issue 6
Pg. 293-9
ISSN: 1918-1523 [Electronic] United States |
PMID | 26474382
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Analgesics, Opioid
- Delayed-Action Preparations
- Hydromorphone
|
Topics |
- Administration, Oral
- Adult
- Aged
- Aged, 80 and over
- Analgesics, Opioid
(administration & dosage)
- Delayed-Action Preparations
- Female
- Humans
- Hydromorphone
(administration & dosage)
- Male
- Middle Aged
- Neoplasms
(complications)
- Pain
(drug therapy)
- Pain Management
- Pain Measurement
- Patient Compliance
- Prospective Studies
- Republic of Korea
- Treatment Outcome
|