Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2008-4-28
pubmed:abstractText
Methylnaltrexone, a peripherally-acting quaternary opioid antagonist, is an investigational treatment for opioid-induced constipation in patients with advanced illness. This randomized, parallel-group, repeated dose, dose-ranging trial included a double-blind phase for one week followed by an open-label phase for a maximum of three weeks. Opioid-treated patients with advanced illness who met criteria for opioid-induced constipation despite laxative therapy were potentially eligible. Double-blind treatment occurred on Days 1, 3, and 5; open-label therapy could be administered as often as every other day. The initial dose range of 1mg, 5mg, or 12.5mg was extended by adding a 20mg group during the study while still maintaining the double blind; the initial open-label dose of 5mg could be titrated. The primary outcome was a laxation response within four hours after the first dose. Thirty-three patients received at least one dose of methylnaltrexone. Only one of 10 patients (10%) who received the 1mg dose experienced laxation within four hours of dosing. The median time to laxation was >48 hours for the 1mg dose group, compared to 1.26 hours for all patients receiving >or=5mg (P=0.0003). There was no apparent dose-response above 5mg. Most adverse events were related to the gastrointestinal system, were mild, and did not lead to discontinuation. In conclusion, methylnaltrexone relieved opioid-induced constipation at doses >or=5mg in patients with advanced illness, and did not reduce analgesia or cause opioid withdrawal symptoms.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0885-3924
pubmed:author
pubmed:issnType
Print
pubmed:volume
35
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
458-68
pubmed:meshHeading
pubmed-meshheading:18440447-Acquired Immunodeficiency Syndrome, pubmed-meshheading:18440447-Adult, pubmed-meshheading:18440447-Aged, pubmed-meshheading:18440447-Aged, 80 and over, pubmed-meshheading:18440447-Analgesics, Opioid, pubmed-meshheading:18440447-Diarrhea, pubmed-meshheading:18440447-Dose-Response Relationship, Drug, pubmed-meshheading:18440447-Double-Blind Method, pubmed-meshheading:18440447-Female, pubmed-meshheading:18440447-Humans, pubmed-meshheading:18440447-Injections, Subcutaneous, pubmed-meshheading:18440447-Male, pubmed-meshheading:18440447-Middle Aged, pubmed-meshheading:18440447-Naltrexone, pubmed-meshheading:18440447-Narcotic Antagonists, pubmed-meshheading:18440447-Neoplasms, pubmed-meshheading:18440447-Pain, pubmed-meshheading:18440447-Pain Measurement, pubmed-meshheading:18440447-Quaternary Ammonium Compounds, pubmed-meshheading:18440447-Terminal Care
pubmed:year
2008
pubmed:articleTitle
Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced illness: a double-blind, randomized, parallel group, dose-ranging study.
pubmed:affiliation
Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, New York 10003, USA. rporteno@chpnet.org
pubmed:publicationType
Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't