Effects of metoclopramide nasal spray: A Synthesis of Findings from 11 Studies

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Original Abstract of the Article

Major Research Findings

Methylnaltrexone is a peripherally acting opioid receptor antagonist, meaning it blocks the effects of opioids in the body without affecting the brain. 4 Several studies have investigated its effects on various opioid-induced side effects. Studies have shown that methylnaltrexone effectively reduces subjective effects like nausea, skin itch, stimulation, and flushing after morphine administration. 4 It also prevents morphine-induced delays in gastrointestinal transit time, without affecting pain relief. 1 Methylnaltrexone has been demonstrated to be safe and well-tolerated in healthy individuals. 2 However, some studies have observed orthostatic hypotension as a dose-limiting adverse effect. 2 Another study highlighted abdominal pain as a common adverse event during methylnaltrexone treatment for opioid-induced constipation. 8

Benefits and Risks

Benefit Summary

Methylnaltrexone offers potential benefits by reducing undesirable side effects associated with opioid medications, such as nausea, itchiness, and gastrointestinal issues. It can help maintain quality of life for patients on opioid therapy by addressing these side effects. 4 1

Risk Summary

While generally considered safe, methylnaltrexone can cause orthostatic hypotension, particularly at higher doses. 2 Abdominal pain has also been reported as a common side effect. 8 The dosage of methylnaltrexone should be carefully determined by a doctor based on individual patient needs.

Comparison Across Studies

Commonalities

The studies consistently demonstrate that methylnaltrexone effectively blocks peripheral opioid effects without affecting central analgesia. 1 This suggests its potential to mitigate opioid-induced side effects while preserving the intended pain-relieving benefits of opioids. 4 3

Differences

The studies vary in terms of the route of administration (oral, intravenous, subcutaneous), the dose of methylnaltrexone used, and the specific opioid studied. 3 7 11 The choice of these factors likely depends on the research question and the specific patient population.

Consistency and Contradictions

The majority of the research consistently supports the effectiveness of methylnaltrexone in treating opioid-induced constipation. 1 5 7 11 6 3 However, some studies have reported the occurrence of abdominal pain as a side effect, which requires further investigation to understand the underlying mechanisms and identify potential mitigation strategies. 8

Practical Implications

Methylnaltrexone can be a valuable tool for managing opioid-induced side effects, especially constipation. 1 However, it's crucial to consult a doctor to determine the appropriate dosage and route of administration based on individual needs. 2 Patients should be aware of potential side effects, such as orthostatic hypotension and abdominal pain, and report any concerning symptoms to their doctor promptly. 2 8

Limitations of Current Research

The research on methylnaltrexone is ongoing, and there are still some gaps in our understanding. For example, long-term effects and safety need further evaluation. 9 The effectiveness of methylnaltrexone may vary depending on individual factors, such as the type of opioid used and the patient's underlying health conditions. 6 Further research is necessary to identify the optimal use of methylnaltrexone in various clinical settings and patient populations.

Future Research Directions

Future research should focus on exploring the long-term safety and efficacy of methylnaltrexone, investigating its effectiveness across different patient populations and opioid types, and understanding its interactions with other medications. 11 6 9 Additionally, research on potential mechanisms contributing to abdominal pain and developing strategies for mitigating this side effect is warranted. 8

Conclusion

Methylnaltrexone has emerged as a promising agent for managing opioid-induced side effects, particularly constipation, while preserving pain relief. 1 3 11 However, its use should be carefully considered, with proper dosage and monitoring for potential side effects. 2 Continued research is needed to further optimize its use in clinical practice and address any remaining uncertainties. 9 11 6

Literature analysis of 11 papers
Positive Content
11
Neutral Content
0
Negative Content
0
Article Type
11
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0
0
11
1.

Methylnaltrexone prevents morphine-induced delay in oral-cecal transit time without affecting analgesia: a double-blind randomized placebo-controlled trial.

Author: YuanC S, FossJ F, O'ConnorM, ToledanoA, RoizenM F, MossJ

Opioid-induced constipation relief

Methylnaltrexone, a quaternary opioid antagonist, effectively prevented morphine-induced changes in gastrointestinal motility and transit without affecting analgesia in humans. This suggests potential for methylnaltrexone as an adjunct to opioids for managing opioid-induced constipation.

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.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

2.

Safety and tolerance of methylnaltrexone in healthy humans: a randomized, placebo-controlled, intravenous, ascending-dose, pharmacokinetic study.

Author: FossJ F, O'ConnorM F, YuanC S, MurphyM, MossJ, RoizenM F

Opioid side effects treatment
Orthostatic hypotension

This study found that methylnaltrexone, a quaternary opioid antagonist, was well tolerated at doses of 0.32 mg/kg in healthy humans, with the dose-limiting adverse effect being orthostatic hypotension.

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.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

3.

The safety and efficacy of oral methylnaltrexone in preventing morphine-induced delay in oral-cecal transit time.

Author: YuanC S, FossJ F, OsinskiJ, ToledanoA, RoizenM F, MossJ

Oral methylnaltrexone
Prevents constipation

Oral methylnaltrexone, a quaternary opioid antagonist, effectively prevented morphine-induced delay in gastrointestinal transit in healthy volunteers. This suggests its potential use in managing opioid-induced constipation.

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.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

4.

Efficacy of orally administered methylnaltrexone in decreasing subjective effects after intravenous morphine.

Author: YuanC S, FossJ F, O'ConnorM, OsinskiJ, RoizenM F, MossJ

Reduce opioid side effects

Oral methylnaltrexone, a selective peripheral opioid receptor antagonist, significantly decreased subjective ratings of nausea, skin itch, stimulated, and flushing after intravenous morphine injection.

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.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

5.

Effects of enteric-coated methylnaltrexone in preventing opioid-induced delay in oral-cecal transit time.

Author: YuanC S, FossJ F, O'ConnorM, KarrisonT, OsinskiJ, RoizenM F, MossJ

Gastrointestinal effects prevention

Methylnaltrexone, the first peripheral opioid receptor antagonist, has the potential to prevent or reverse the gastrointestinal side effects of opioids. Studies showed that oral methylnaltrexone prevented morphine-induced delays in gastrointestinal transit time.

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.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

6.

The effects of methylnaltrexone alone and in combination with acutely administered codeine on gastrointestinal and colonic transit in health.

Author: WongB S, RaoA S, CamilleriM, ManabeN, McKinzieS, BusciglioI, BurtonD D, RyksM, ZinsmeisterA R

Methylnaltrexone did not affect gastrointestinal or colonic transit and did not reverse acute codeine-associated delayed gut transit in healthy individuals.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery.

Author: AnissianLucas, SchwartzHarry W, VincentKevin, VincentHeather K, CarpenitoJennifer, StamblerNancy, RamakrishnaTage

Laxation
Gastrointestinal side effects

Subcutaneous methylnaltrexone was effective and well tolerated in treating acute opioid-induced constipation (OIC) after orthopedic procedures. Patients receiving methylnaltrexone achieved laxation significantly faster than those receiving placebo.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
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

8.

Characterization of abdominal pain during methylnaltrexone treatment of opioid-induced constipation in advanced illness: a post hoc analysis of two clinical trials.

Author: SlatkinNeal E, LynnRichard, SuChinyu, WangWenjin, IsraelRobert J

Opioid-induced constipation treatment
Abdominal pain

Methylnaltrexone, a drug for opioid-induced constipation, was found to be associated with abdominal pain as the most common side effect.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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

9.

Methylnaltrexone: its pharmacological effects alone and effects on morphine in healthy volunteers.

Author: ZacnyJames P, WroblewskiKristen, CoalsonDennis W

Opioid-induced constipation

This article reviews the use of methylnaltrexone bromide (MTNX) for opioid-induced constipation. Studies suggest that MTNX may alter other opioid-induced effects besides constipation, highlighting the potential role of peripheral opioid actions.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

10.

The effects of morphine and methylnaltrexone on gastrointestinal pain in healthy male participants.

Author: BrokjaerA, OlesenA E, ChristrupL L, DahanA, DrewesA M

Opioid side effect relief
Local analgesia interference

This study explored the effect of rectal morphine before and after blocking opioid receptors outside the central nervous system with methylnaltrexone (MNTX).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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

11.

Protocol for a randomised control trial of methylnaltrexone for the treatment of opioid-induced constipation and gastrointestinal stasis in intensive care patients (MOTION).

Author: PatelParind B, BrettStephen J, O'CallaghanDavid, AnjumAisha, CrossMary, WarwickJane, GordonAnthony C

Gastrointestinal dysmotility treatment

Methylnaltrexone, a peripheral opioid antagonist, may be effective in reversing opioid-induced constipation and gastrointestinal dysmotility in intensive care patients. This trial investigates the potential benefits of methylnaltrexone in managing these common side effects of opioid sedation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
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

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