• J Pain Symptom Manage · Dec 2012

    Meta Analysis

    Safety and Tolerability of Once-Daily OROS(®) hydromorphone extended-release in opioid-tolerant adults with moderate-to-severe chronic cancer and noncancer pain: pooled analysis of 11 clinical studies.

    • Srinivas R Nalamachu, Michael Kutch, and Martin E Hale.
    • International Clinical Research Institute, Overland Park, Kansas 66211, USA. nalamachu@yahoo.com
    • J Pain Symptom Manage. 2012 Dec 1; 44 (6): 852865852-65.

    ContextThe efficacy and tolerability of once-daily hydromorphone extended release (ER) (OROS(®) hydromorphone ER, Exalgo(®), Mallinckrodt Brand Pharmaceuticals, Inc., Hazelwood, MO) in patients with chronic cancer and noncancer pain have been reported in previous studies.ObjectivesThe objective of this analysis was to assess the pooled safety data of OROS hydromorphone ER in opioid-tolerant patients with chronic cancer and noncancer pain.MethodsSafety results were pooled from 11 clinical studies in opioid-tolerant patients: one 12-week, double-blind, placebo-controlled study; three active-controlled studies; and seven uncontrolled studies (durations of three to 52 weeks). Patients were included in this analysis if they took ≥1 dose of study medication. Descriptive statistics were used to analyze baseline and demographic characteristics, supplemental analgesic use, and incidence of adverse events (AEs).ResultsIn total, 1251 opioid-tolerant patients received ≥1 dose of OROS hydromorphone ER. Mean (SD) duration of exposure was 43.1 (67.8) days (range 1-396 days), and mean (SD) daily dose was 43.4 (47.1) mg. Overall, 1081 patients (86.4%) used supplemental rescue analgesics. The overall incidence of AEs was 76.9%. The most frequently reported AEs were nausea (23.2%), constipation (22.4%), vomiting (14.4%), somnolence (12.9%), and headache (12.8%). Treatment-related constipation occurred in 20.5% of patients, nausea in 16.8%, somnolence in 11.8%, vomiting in 8.2%, and headache in 7.0%. Serious adverse events occurred in 13.5% of patients, with the most frequently reported serious adverse events being dehydration, nausea, and vomiting. No treatment-related deaths occurred.ConclusionOnce-daily OROS hydromorphone ER demonstrated a safety and tolerability profile in opioid-tolerant patients that is consistent with the known safety profiles of opioids.Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

      Pubmed     Free full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…