Side Effects of alvimopan: A Synthesis of Findings from 7 Studies

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Original Abstract of the Article

Major research findings

Alvimopan, a peripherally acting mu-opioid receptor antagonist, has been shown to be effective in treating opioid-induced bowel dysfunction and postoperative ileus. 6 , 4 , 2 , 1 Alvimopan works by blocking opioids from binding to receptors in the gut, which helps to improve bowel function without affecting pain relief. 6 , 4 , 2 , 1 However, alvimopan has been linked to an increased risk of myocardial infarction, and its use is restricted to hospitalized patients. 3

Reasons for side effects

Alvimopan is designed to target opioid receptors in the gut, but it may also have effects on other parts of the body, including the heart. 3 This potential for broader effects could explain why alvimopan has been associated with myocardial infarction. 3

Common side effects

Abdominal pain

Abdominal pain has been reported as a side effect of alvimopan. 6 This may be related to the drug's impact on gut motility. 6

Flatulence

Flatulence has been reported as a side effect of alvimopan. 6 This may be related to the drug's impact on gut motility. 6

Diarrhea

Diarrhea has been reported as a side effect of alvimopan. 6 This may be related to the drug's impact on gut motility. 6

Myocardial infarction

Myocardial infarction has been reported as a side effect of alvimopan. 3 This is a serious concern, and it's why alvimopan's use is limited to hospitalized patients. 3

Side effect countermeasures

Abdominal pain, flatulence, diarrhea

In some cases, reducing the dosage of alvimopan may help to alleviate gastrointestinal side effects such as abdominal pain, flatulence, and diarrhea. 6 Additionally, appropriate medications can be prescribed by a doctor to manage these symptoms. 6

Myocardial infarction

To minimize the risk of myocardial infarction, careful monitoring of heart health and consideration of alternative treatment options are crucial. 3 The use of alvimopan is restricted to hospitalized patients where such monitoring can be readily provided. 3

Comparison between studies

Common points of studies

Multiple studies have shown that alvimopan is effective in treating opioid-induced constipation and postoperative ileus. 6 , 4 , 2 , 1 Furthermore, alvimopan has been shown to improve these conditions without interfering with the pain relief provided by opioids. 6 , 4 , 2 , 1

Differences in studies

The specific side effects reported for alvimopan vary across studies. 6 , 3 While some studies suggest alvimopan is generally well-tolerated, others have highlighted a potential increased risk of myocardial infarction. 6 , 3 These differences may be attributable to factors such as study design, participant characteristics, and other variables.

Points to note regarding application to real life

While alvimopan holds promise for treating opioid-induced constipation and postoperative ileus, the potential for myocardial infarction is a serious consideration. 3 Strict adherence to a doctor's instructions, prompt reporting of any side effects, and careful monitoring of heart health are essential when alvimopan is used. 3

Limitations of current research

Long-term data on the safety and efficacy of alvimopan is still limited. 3 Further research is needed to fully understand the potential cardiac effects of alvimopan. 3

Future research directions

Large-scale clinical trials are warranted to assess the long-term safety and efficacy of alvimopan. 3 Additional research is also needed to investigate the cardiac impact of alvimopan. 3

Conclusion

Alvimopan is a promising treatment option for opioid-induced bowel dysfunction and postoperative ileus. 6 , 4 , 2 , 1 However, the potential for myocardial infarction requires careful consideration. 3 Close monitoring by a doctor, prompt reporting of any side effects, and awareness of the risks are essential when alvimopan is used. 3 Further research is crucial to gather more comprehensive data on the long-term safety and efficacy of alvimopan, including its potential cardiac effects. 3

Literature analysis of 7 papers
Positive Content
7
Neutral Content
0
Negative Content
0
Article Type
2
1
0
3
7
1.

A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain.

Author: JansenJan-Peter, LorchDaniel, LanganJohn, LaskoBen, HermannsKai, KleoudisChristi S, SnidowJerry W, PierceAmy, WurzelmannJohn, MortensenEric R

Opioid induced constipation treatment
Pain relief

Alvimopan, a peripherally acting mu-opioid receptor antagonist, was found to be effective in treating opioid-induced constipation (OIC) in a 12-week, double-blind, placebo-controlled trial. In patients receiving opioids for non-cancer pain, the alvimopan 0.5 mg twice-daily group showed a significantly greater proportion of patients experiencing ≥ 3 spontaneous bowel movements (SBMs) per week compared to placebo (72% vs 48%). Alvimopan twice daily also improved other OIC symptoms and reduced the need for rescue laxatives. The treatment was generally well tolerated and did not increase opioid requirements or pain intensity scores.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain.

Author: IrvingGordon, PénzesJanos, RamjattanBrian, CousinsMichael, RauckRichard, SpieringsEgilius L H, KleoudisChristi S, SnidowJerry W, PierceAmy, WurzelmannJohn, MortensenEric R

Opioid induced bowel dysfunction
Pain relief

Alvimopan, a peripherally acting mu-opioid receptor antagonist, was studied for its effectiveness in treating opioid-induced constipation (OIC) in a 12-week, double-blind, placebo-controlled trial in patients receiving opioids for non-cancer pain. Alvimopan showed numerical superiority over placebo in improving OIC symptoms and reducing the need for rescue laxatives. The treatment was well tolerated and did not antagonize opioid analgesia.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

The involvement of the mu-opioid receptor in gastrointestinal pathophysiology: therapeutic opportunities for antagonism at this receptor.

Author: DeHaven-HudkinsDiane L, DeHavenRobert N, LittlePatrick J, TechnerLee M

Opioid-induced bowel dysfunction treatment

Peripherally acting mu-opioid receptor antagonists, such as alvimopan and methylnaltrexone, have shown efficacy in treating opioid-induced gastrointestinal side effects without affecting opioid-mediated analgesia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Meta-analysis: Alvimopan vs. placebo in the treatment of post-operative ileus.

Author: TanE K, CornishJ, DarziA W, TekkisP P

Improved GI function
Reduced discharge time

Alvimopan showed significant advantages over placebo in restoring gastro-intestinal function, and reduced time to discharge following major abdominal surgery.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

6.

Alvimopan* (ADL 8-2698) is a novel peripheral opioid antagonist.

Author: SchmidtW K

Improved bowel function
Reduced hospital stay
Reduced nausea
Reduced opioid side effects
Reduced vomiting
Reversal of opioid bowel dysfunction
Abdominal pain
Diarrhea
Flatulence

Alvimopan is a peripherally restricted opioid antagonist that specifically targets the gastrointestinal (GI) tract. In healthy subjects, it antagonized loperamide-induced changes in GI transit and prevented morphine-induced delays without affecting central opioid effects. In patients with postoperative ileus (POI), alvimopan shortened the time to normal bowel function and reduced hospital stay. It also reduced postoperative nausea and vomiting without compromising analgesia. Alvimopan also reversed opioid bowel dysfunction in patients with chronic pain without affecting analgesia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

[Treatment of constipation in chronic pain patients].

Author: ShimoyamaNaohito, ShimoyamaMegumi

Prevent constipation

Opioid analgesics are commonly used to treat chronic pain, but they can cause constipation as a side effect. New drugs that block opioid receptors in the gut, such as methylnaltrexone and alvimopan, show promise in preventing this side effect without affecting the analgesic effects of opioids.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Japanese

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