A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics

Title
A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics
Author(s)
이경희한혜숙[한혜숙]이기형[이기형]류정선[류정선]김영철[김영철]박경태[박경태]오소연[오소연]안진석[안진석]박성우[박성우]안중배[안중배]
Keywords
OROS(R) HYDROMORPHONE; OPIOID ROTATION; MANAGEMENT; PREVALENCE; VALIDATION; THERAPY; RELIEF
Issue Date
201403
Publisher
SPRINGER
Citation
SUPPORTIVE CARE IN CANCER, v.22, no.3, pp.741 - 750
Abstract
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. 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). 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). 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.
URI
http://hdl.handle.net/YU.REPOSITORY/32945http://dx.doi.org/10.1007/s00520-013-2030-1
ISSN
0941-4355
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의과대학 > 내과학교실 > Articles
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