A Phase III Double-Blind, Placebo-Controlled Trial of Every Other Day Dosing of Methylnaltrexone for Opioid-Induced Constipation in Advanced Illness

Slatkin, Neal E.; Karver, Sloan Beth; Thomas, Jaime; Chamberlain, Bruce; Austin–Cooney, G.; Watt, Charles Kevin; Winston, Jaron; Cross, Karen L.; McGrew, D.; Stambler, Nancy; Israel, Robert J.

doi:10.1053/j.gastro.2006.06.099

Cited by 5 publications

(3 citation statements)

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“…There were no reports of systemic opioid withdrawal or loss of analgesia. 1,9,10 This study enrolled 78 patients with cancer, and in this subgroup, results were similar to those observed in the entire study population. More patients with cancer who were treated with methylnaltrexone and the clinicians of those patients reported the patient's bowel status as improved compared with the placebo group on day 7 (patients: 75% vs 37.5%, P < 0.05; clinicians: 65.6% vs 37.5%, P < 0.05) and day 14 (patients: 75% vs 37.9%, P < 0.05; clinicians: 68.8% vs 46.7%, P < 0.05).…”

Section: Comparative Efficacysupporting

confidence: 68%

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Methylnaltrexone Bromide, Subcutaneous

2008

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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and are also available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The September 2008 monograph topics are on difluprednate ophthalmic emulsion, eltrombopag, ustekinumab, denosumab, and milnacipran. The DUE is on certolizumab pegol.

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Section: Comparative Efficacysupporting

confidence: 68%

“…Adverse reactions associated with methylnaltrexone therapy have included abdominal cramping, diarrhea, dizziness, flatulence, nausea, and soft stool (see Table 2). 1,5,9,13,14,18,19 Abdominal cramping has been moderate in some patients but appears to decrease or to be relieved after a bowel movement. 5,18…”

Section: Adverse Reactionsmentioning

confidence: 99%

Methylnaltrexone Bromide, Subcutaneous

2008

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“…In the second study [35], 134 patients (~60% cancer) were randomly assigned to receive every-other-day dosing of either placebo or subcutaneous MNTX, 0.15 mg/kg, for 2 weeks. Co-primary endpoints were the percentages of laxation response after the first dose, which were 48% and 15% for MNTX, 0.15 mg/kg.…”

Section: Peripheral Opioid Antagonists: Alvimopan and Methylnaltrexonementioning

confidence: 99%

Cancer-related constipation

Thomas

2007

Curr Oncol Rep

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Cancer-related constipation is common and a significant detractor from patient quality of life. It has many possible causes and is still not well understood. Information is lacking on therapies for cancer-related constipation among current medications approved by the US Food and Drug Administration (FDA). Most agents have only been formally tested in comparison with placebo in chronic idiopathic constipation if at all. Few comparative studies of laxatives have been performed to establish superiority or synergy. As we understand more about the physiology of the gastrointestinal tract, new targeted therapies have become available. These include a selective chloride channel activator, lubiprostone, and a selective 5HT4 serotonin receptor agonist, tegaserod, both of which have been FDA approved for chronic idiopathic constipation. The role of these agents in cancer-related constipation remains to be seen. On the horizon are two investigational peripherally acting opioid receptor antagonists, alvimopan and methylnaltrexone. Preliminary results in cancer-related constipation suggest that these agents may be important additions to our treatment repertoire.

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Methylnaltrexone: A Peripherally Acting Opioid Antagonist

Yuan

Israel

2009

Opiate Receptors and Antagonists

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A Phase III Double-Blind, Placebo-Controlled Trial of Every Other Day Dosing of Methylnaltrexone for Opioid-Induced Constipation in Advanced Illness

Cited by 5 publications

References 0 publications

Methylnaltrexone Bromide, Subcutaneous

Methylnaltrexone Bromide, Subcutaneous

Cancer-related constipation

Methylnaltrexone: A Peripherally Acting Opioid Antagonist

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