A phase III double-blind placebo-controlled trial of methylnaltrexone (MNTX) for opioid-induced constipation (OIC) in advanced medical illness (AMI)

Thomas, Jaime; Lipman, Arthur G.; Slatkin, Neal E.; Wilson, G. Heather; Moehl, M.; Wellman, Charles; Zhukovsky, Donna S.; Stephenson, Richard; Stambler, Nancy; Israel, Robert J.

doi:10.1200/jco.2005.23.16_suppl.lba8003

Cited by 19 publications

(18 citation statements)

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“…Patients who had a suspected primary cause of constipation other than opioids were excluded. In the first study [34], 154 patients (~80% cancer) received a single double-blind dose of placebo or subcutaneous MNTX, 0.15 mg/kg or 0.3 mg/kg. The primary outcome was the percentage of patients with laxation within 4 hours of dosing, which was 62%, 58%, and 13% for MNTX, 0.15 mg/kg; MNTX, 0.3 mg/kg; and placebo, respectively.…”

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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Section: Peripheral Opioid Antagonists: Alvimopan and Methylnaltrexonementioning

confidence: 99%

Cancer-related constipation

Thomas

2007

Curr Oncol Rep

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“…Methylnaltrexone has also reported promising results in the treatment of OIC [35,[75][76][77][78][79] . The efficacy and tolerability of methylnaltrexone have been demonstrated in a phase III trial involving 154 chronic opioid users with advanced diseases [80] . Recent studies have shown that subcutaneous methylnaltrexone rapidly induced laxation in patients with advanced illness and OIC [81,82] .…”

Section: Other Potential Strategiesmentioning

confidence: 99%

Meeting the Challenges of Opioid-Induced Constipation in Chronic Pain Management – A Novel Approach

et al. 2008

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Opioid analgesics are the cornerstone of pain management for moderate-to-severe cancer pain and, increasingly, chronic noncancer pain. Despite proven analgesic efficacy, the use of opioids is commonly associated with frequently dose-limiting constipation that seriously impacts on patients’ quality of life. Agents currently used to manage opioid-induced constipation (OIC), such as laxatives, do not address the underlying opioid receptor-mediated cause of constipation and are often ineffective. A significant need therefore exists for more effective treatment options. A novel approach for selectively and locally antagonizing the gastrointestinal effects of opioids involves the coadministration of a μ-opioid receptor antagonist with negligible systemic availability, such as oral naloxone. Combination therapy with prolonged-release (PR) oxycodone plus PR naloxone has been shown to provide effective analgesia while preventing or reducing constipation. The current article highlights this novel strategy in its potential to significantly improve the quality of life of patients suffering from chronic pain, affording patients the benefit of full analgesia, without the burden of OIC.

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“…MNTX301 was a double-blind, randomized, placebo-controlled study that enrolled 154 patients with advanced medical illness and opioid-induced constipation; they had no laxation (bowel movement) for 48 hours despite the use of laxatives and stool softeners. 12 MNTX was given subcutaneously at 0.15 mg/kg, or 0.30 mg/kg and the primary endpoint was laxation within four hours. The primary endpoint was achieved in 62% and 58% of patients treated with MNTX 0.15 or 0.30 mg/kg, respectively, compared with 13% of patients treated with placebo (P Ͻ .0001).…”

Section: Methylnaltrexone (Mntx)mentioning

confidence: 99%

Peripherally Acting Mu-Opioid-Receptor Antagonists and the Connection Between Postoperative Ileus and Pain Management: The Anesthesiologist’s View and Beyond

Sinatra

2006

Journal of PeriAnesthesia Nursing

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A phase III double-blind placebo-controlled trial of methylnaltrexone (MNTX) for opioid-induced constipation (OIC) in advanced medical illness (AMI)

Cited by 19 publications

References 0 publications

Cancer-related constipation

Cancer-related constipation

Meeting the Challenges of Opioid-Induced Constipation in Chronic Pain Management – A Novel Approach

Peripherally Acting Mu-Opioid-Receptor Antagonists and the Connection Between Postoperative Ileus and Pain Management: The Anesthesiologist’s View and Beyond

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