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- Title
A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics.
- Authors
Han, Hye-Suk; Lee, Ki; Lee, Kyung; Ryu, Jeong; Kim, Young; Park, Seung; Oh, Ho-Suk; Park, Kyung; Kwon, Jung; Lee, Pyung; Lee, Won; Kim, Yang; Ahn, Joong; Jeon, Seong; Lee, Sung; Seol, Young; Kang, Jung; Yuh, Young; Oh, So; Kim, Suk
- Abstract
Purpose: The objective of this study was to evaluate whether extended-release hydromorphone (osmotic-controlled release oral delivery system [OROS] hydromorphone) treatment provided pain relief in cancer patients whose pain was inadequately controlled by other analgesics. Methods: In this prospective, open-label, multicenter trial, patients who have sustained cancer pain with other analgesics were enrolled. After the baseline evaluation (visit 1), OROS hydromorphone was administered. Two evaluations (visits 2 and 3) were made: 29 ± 7 and 57 ± 7 days later, respectively. The primary end point was the pain intensity difference (PID) at visit 3 relative to visit 1 (expressed as percent PID). Results: In total, 879 patients were screened and 432 completed all three visits. Of the 874 full analysis set patients, 343 (39.2 %) improved by more than 30 % PID. Of the 432 per-protocol patients, 282 (65.3 %) improved by more than 30 % PID. At visits 2 and 3, the degree of sleep disturbance, the number of awakenings, and the degree of sleep satisfaction were significantly better than at visit 1 (all P < 0.0001 for both visit 1-visit 2 and visit 1-visit 3). However, this pain relief was not associated with improved quality of life ( P = 0.326 and P = 0.055 for visit 1-visit 2 and visit 1-visit 3, respectively). Conclusions: This study suggested that active pain management using the strong opioid OROS hydromorphone was beneficial in the management of cancer pain that was not controlled by other analgesics.
- Subjects
CANCER pain treatment; ANALGESICS; ORAL drug administration; CANCER patients; DRUG administration; CLINICAL trials; LONGITUDINAL method
- Publication
Supportive Care in Cancer, 2014, Vol 22, Issue 3, p741
- ISSN
0941-4355
- Publication type
Article
- DOI
10.1007/s00520-013-2030-1