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

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...

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Publicado en:Supportive Care in Cancer Vol. 22; no. 3; pp. 741 - 751
Autores principales: Han, Hye-Suk, Lee, Ki Hyeong, Lee, Kyung Hee, Ryu, Jeong Seon, Kim, Young Chul, Park, Seung Woo, Oh, Ho-Suk, Park, Kyung Tae, Kwon, Jung Hye, Lee, Pyung Bok, Lee, Won Sik, Kim, Yang Soo, Ahn, Joong Bae, Jeon, Seong Woo, Lee, Sung Yong, Seol, Young Mi, Kang, Jung Hun, Yuh, Young Jin, Oh, So Yeon, Kim, Suk Ran
Formato: research Journal Article
Publicado: Springer Nature Mar2014
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Mar2014
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00520-013-2030-1
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        atl: A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics.
      aug:
        au:
          Han, Hye-Suk
          Lee, Ki Hyeong
          Lee, Kyung Hee
          Ryu, Jeong Seon
          Kim, Young Chul
          Park, Seung Woo
          Oh, Ho-Suk
          Park, Kyung Tae
          Kwon, Jung Hye
          Lee, Pyung Bok
          Lee, Won Sik
          Kim, Yang Soo
          Ahn, Joong Bae
          Jeon, Seong Woo
          Lee, Sung Yong
          Seol, Young Mi
          Kang, Jung Hun
          Yuh, Young Jin
          Oh, So Yeon
          Kim, Suk Ran
      sug:
        subj:
          Analgesics, Opioid Therapeutic Use
          Breakthrough Pain Drug Therapy
          Delayed-Action Preparations Therapeutic Use
          Dihydromorphinone Therapeutic Use
          Neoplasms Complications
          Adult
          Aged
          Aged, 80 and Over
          Analgesics, Opioid Administration and Dosage
          Breakthrough Pain Etiology
          Delayed-Action Preparations Administration and Dosage
          Dihydromorphinone Administration and Dosage
          Drug Administration Schedule
          Female
          Human
          Male
          Middle Age
          Neoplasms Epidemiology
          Pain Measurement
          Prospective Studies
          Sleep
          Treatment Outcomes
          Young Adult
          Adult: 19-44 years
          Aged: 65+ years
          Aged, 80 & over
          Middle Aged: 45-64 years
          Female
          Male
      ab: 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.
      pubtype: Academic Journal
      doctype:
        research
        Journal Article
      ougenre: Article
    language: English
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