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

Hye Suk Han, Ki Hyeong Lee, Kyung Hee Lee, Jeong Seon Ryu, Young Chul Kim, Seung Woo Park, Ho Suk Oh, Kyung Tae Park, Jung Hye Kwon, Pyung Bok Lee, Won Sik Lee, Yang Soo Kim, Joong Bae Ahn, Seong Woo Jeon, Sung Yong Lee, Young Mi Seol, Jung Hun Kang, Young Jin Yuh, So Yeon Oh, Suk Ran KimJin Seok Ahn

    Research output: Contribution to journalArticlepeer-review

    7 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)741-750
    Number of pages10
    JournalSupportive Care in Cancer
    Volume22
    Issue number3
    DOIs
    Publication statusPublished - 2014 Mar

    Keywords

    • Analgesics
    • Cancer
    • Hydromorphone
    • Opioid
    • Pain

    ASJC Scopus subject areas

    • Oncology

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