Effects of naloxegol: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Major Research Findings

Research on the effects of naloxegol suggests its efficacy in treating opioid-induced constipation (OIC). Naloxegol is a peripherally acting μ-opioid receptor antagonist (PAMORA), and it is believed to improve constipation by inhibiting the effects of opioids in the intestines. 23 15 9

Several studies have shown that naloxegol is effective in improving OIC symptoms compared to placebo. 24 20 7 In addition, naloxegol has been reported to improve esophageal motility disorders caused by opioids. 16

Furthermore, some research findings indicate that naloxegol may be more effective than other PAMORAs, such as methylnaltrexone. 12 However, it is important to note that naloxegol can cause opioid withdrawal symptoms when used in combination with naloxone. 26

Benefits and Risks

Benefit Summary

Naloxegol may be effective in treating opioid-induced constipation (OIC). Research has shown that naloxegol improves constipation symptoms and increases bowel movements compared to placebo. 24 20 7 Some research findings also suggest that naloxegol may be more effective than other PAMORAs, such as methylnaltrexone. 12 Moreover, naloxegol has been reported to improve esophageal motility disorders caused by opioids. 16 The effects of naloxegol may vary depending on the amount of opioid used and the individual patient's condition. 3

Risk Summary

Side effects of naloxegol include abdominal pain, diarrhea, nausea, vomiting, dizziness, and headache. 22 3 Naloxegol can also cause opioid withdrawal symptoms when used in combination with naloxone. 26 It is important to understand these risks when considering naloxegol use.

Comparison Between Studies

Commonalities

Many studies have shown that naloxegol is effective in treating OIC. 24 20 12 These studies show that naloxegol improves constipation symptoms and increases bowel movements compared to placebo. 24 20 12

Differences

Studies comparing the effectiveness of naloxegol with other PAMORAs show that naloxegol may be more effective than methylnaltrexone. 12 However, there are reports that naloxegol can cause opioid withdrawal symptoms when used in combination with naloxone. 26 These studies suggest the need for further research on the use of naloxegol.

Consistency and Discrepancies of Results

Studies on the effects of naloxegol show consistent results, but some discrepancies have also been observed. The effects of naloxegol may vary depending on the amount of opioid used and the individual patient's condition. 3 In addition, studies comparing the effectiveness of naloxegol with other PAMORAs have found that naloxegol may be more effective than methylnaltrexone. 12 However, there are reports that naloxegol can cause opioid withdrawal symptoms when used in combination with naloxone. 26 These discrepancies suggest the need for further research on the use of naloxegol.

Considerations for Real-World Application

While naloxegol may be effective in treating OIC, it is not effective for all patients. When considering the use of naloxegol, various factors need to be taken into account, such as the patient's condition and the amount of opioid used. Also, naloxegol can cause opioid withdrawal symptoms when used in combination with naloxone. 26 It is important to consult a doctor before taking naloxegol.

Limitations of Current Research

Research on the effects of naloxegol is still insufficient. Further research is needed. In particular, studies comparing the effectiveness of naloxegol with other PAMORAs and studies investigating the incidence of opioid withdrawal symptoms caused by naloxegol are needed.

Future Research Directions

Future research should investigate the long-term effects and safety of naloxegol. Additionally, studies comparing the effectiveness of naloxegol with other PAMORAs and studies investigating the incidence of opioid withdrawal symptoms caused by naloxegol are needed. Furthermore, research is needed to determine how the effects of naloxegol change depending on the type and amount of opioid used.

Conclusion

Naloxegol is a drug that may be effective in treating OIC. However, it is not effective for all patients, and there are risks associated with using naloxegol. It is important to consult a doctor before taking naloxegol. Research on the effects of naloxegol is still insufficient. Further research is needed.

Literature analysis of 28 papers
Positive Content
24
Neutral Content
0
Negative Content
4
Article Type
2
1
1
6
27
2.

Effects of naloxegol on whole gut transit in opioid-naïve healthy subjects receiving codeine: A randomized, controlled trial.

Author: HalawiH, VijayvargiyaP, BusciglioI, OduyeboI, KhemaniD, RyksM, RhotenD, BurtonD, SzarkaL A, AcostaA, CamilleriM

Constipation
Nausea
Vomiting

Naloxegol did not reverse the retardation of gastric, small bowel, or colonic transit induced by codeine in healthy opioid-naïve volunteers.

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

3.

Safety, tolerability, pharmacokinetics, and pharmacodynamic effects of naloxegol at peripheral and central nervous system receptors in healthy male subjects: A single ascending-dose study.

Author: EldonMichael A, KuglerAlan R, MedveRobert A, BuiKhanh, ButlerKathleen, SostekMark

Antagonism of morphine effects
Safety and tolerability
Dizziness
Headache
Nausea
Somnolence

This study evaluated the safety, tolerability, and pharmacokinetics of naloxegol, a PEGylated derivative of naloxone, in healthy men. Naloxegol showed dose-ordered antagonism of morphine's peripheral gastrointestinal effects with minimal antagonism of its central nervous system effects. The drug was generally safe and well tolerated at single doses up to 1000 mg.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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.

Language : English

4.

Effects of CYP3A Modulators on the Pharmacokinetics of Naloxegol.

Author: BuiKhanh, ZhouDiansong, SostekMark, SheFahua, Al-HunitiNidal

Opioid-induced constipation treatment
Liver enzyme elevation

The study evaluated the effects of CYP3A inhibition and induction on the pharmacokinetics, safety, and tolerability of naloxegol, a peripherally acting μ-opioid receptor antagonist, in healthy volunteers. The study found that naloxegol is a sensitive in vivo substrate of CYP3A4, and its exposure was significantly affected by ketoconazole, diltiazem, and rifampin.

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.

Language : English

5.

The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol.

Author: BuiKhanh, SheFahua, SostekMark

Renal impairment unaffected
Increased exposure

The impact of renal impairment on the pharmacokinetics of a 25-mg oral dose of naloxegol was examined in patients with moderate, severe, or end-stage renal disease (ESRD). While renal impairment minimally affected other pharmacokinetic parameters, it increased exposure in outliers of the moderate and severe impairment groups.

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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol.

Author: BuiKhanh, SheFahua, SostekMark

Opioid-induced constipation treatment

Naloxegol, a peripherally acting µ-opioid receptor antagonist (PAMORA), was assessed in patients with mild or moderate hepatic impairment. Hepatically impaired patients showed a decrease in area under the plasma concentration versus time curve (AUC) despite similar maximum plasma concentrations (Cmax ).

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

An observational post-authorization safety study (PASS) of naloxegol drug utilization in four European countries.

Author: KvarsteinGunnvald, Kindlundh-HögbergAnna Ms, Ould SettiMounir, NamaneRafik, MuzwidzwaRuvimbo, RichterHartmut, HakkarainenKatja M

OIC treatment
Drug interactions

This study described the characteristics of naloxegol users and assessed patterns of naloxegol use and associated factors. The study found that naloxegol was frequently used in vulnerable patient groups and was often discontinued during the first 30 days.

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

Language : English

8.

Naloxegol versus Methylnaltrexone for Opioid-Induced Constipation in Critically Ill Patients.

Author: TobbenDaniel, CarpenterSheniece, KolarRachel, MerrittTyler, YoungTramaine, HauserPaloma, CollierTia

OIC treatment

Enteral naloxegol (NGL) and subcutaneous methylnaltrexone (MNTX) were noninferior in treating opioid-induced constipation (OIC) in critically ill patients. NGL was also cost-effective.

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

Language : English

10.

Management of Opioid-induced Constipation in Older Adults.

Author: HorriganJamie, BhumiSriya, MillerDavid, JafriMikram, TadrosMicheal

OIC treatment
None reported

This review provides guidance on managing opioid-induced constipation (OIC) in older adults. It recommends considering nonpharmacologic interventions and over-the-counter laxatives before moving to prescription opioid receptor antagonists. The review emphasizes the importance of individualizing treatment based on the complex pharmacokinetic profile of aging individuals.

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

Language : English

11.

Naloxegol for Treatment of Opioid-Induced Constipation in the Pediatric Intensive Care Unit.

Author: GillettEthan L, LayesClint A, CrawleyLee, SchexnayderStephen M

Opioid withdrawal symptom prevention
Opioid-induced constipation treatment

This retrospective analysis found that naloxegol was effective in increasing stool output in critically ill children receiving opioids without an increase in opioid-withdrawal symptoms.

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

Language : English

12.

Impact of oral naloxegol vs subcutaneous methylnaltrexone in treatment of opioid-induced constipation in the hospital setting.

Author: NeroRicki, AllenBryan, HailuKirubel, NoorRefat, TheissKimberly

OIC treatment
PAMORA efficacy

Oral naloxegol and subcutaneous methylnaltrexone are both effective treatments for opioid-induced constipation in hospitalized patients, but this study provides no head-to-head comparison of their efficacy, safety, or cost.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

The Impact of P-Glycoprotein on Opioid Analgesics: What's the Real Meaning in Pain Management and Palliative Care?

Author: ColuzziFlaminia, ScerpaMaria Sole, RoccoMonica, FornasariDiego

Constipation management
Pain management
Opioid tolerance
Pharmacoresistance

This review explores the interactions between P-glycoprotein and opioidergic drugs, emphasizing their implications in clinical practice, including pain management, opioid tolerance, and drug-drug interactions.

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

14.

A comparison of naloxegol versus alvimopan at the time of cystectomy and urinary diversion.

Author: FarajKassem S, BunnWeslyn, DurantAdri M, MaulerDavid, ChangYu-Hui H, TysonMark D

Improved perioperative outcomes

This study compares the perioperative outcomes of patients undergoing cystectomy with urinary diversion who receive alvimopan versus naloxegol, two mu-opioid antagonists, to assess their impact on recovery and complications.

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

Language : English

15.

Constipation in Cancer Patients - an Update of Clinical Evidence.

Author: DzierżanowskiTomasz, MercadanteSebastiano

Constipation management
Underdiagnosis

Constipation is a common problem in cancer patients, and it can be caused by many things, including opioid medications. This article discusses the causes and treatments of constipation in cancer patients, including dietary changes, lifestyle modifications, and medications.

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

16.

Effect of Naloxegol on Opioid-Induced Esophageal Motility Disorder.

Author: UlteigCrista, CiezkiKristin, JacobsonMegan, SighMaharaj, SharmaTarun

Treat esophageal dysmotility

This case series reports that 3 patients with coexisting esophageal dysmotility and constipation on chronic opioids experienced improvement in both symptoms after starting naloxegol. This suggests that naloxegol may be beneficial for opioid-induced esophageal dysmotility, and further studies are needed to confirm this finding.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

17.

Naloxegol and Postoperative Urinary Retention: A Randomized Trial.

Author: TuranAlparslan, FangJonathan, EsaWael Ali Sakr, HamadnallaHassan, LeungSteve, PuXuan, RazaSyed, ChelnickDavid, Mounir SolimanLoran, SeifJohn, RuetzlerKurt, SesslerDaniel I

Urinary retention

This randomized controlled trial investigated the effect of naloxegol on opioid-induced bladder dysfunction following hip and knee surgery. The study found no significant difference in residual urine volume between the naloxegol and placebo groups. Therefore, the authors concluded that naloxegol is not recommended for the treatment of postoperative urinary retention.

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

Language : English

18.

Efficacy and Safety of Peripherally Acting μ-Opioid Receptor Antagonist (PAMORAs) for the Management of Patients With Opioid-Induced Constipation: A Systematic Review.

Author: RekatsinaMartina, PaladiniAntonella, DrewesAsbjørn M, AyobFarrah, ViswanathOmar, UritsIvan, CorliOscar, PergolizziJoseph, VarrassiGiustino

OIC treatment
Gastrointestinal side effects

Opioid-induced constipation (OIC) is a common side effect of opioid use. Peripherally acting μ-opioid receptor antagonists (PAMORAs) are effective in reducing OIC. Naloxegol and naldemedine are the most effective PAMORAs, with naldemedine leading to more spontaneous bowel movements. While these drugs are generally well-tolerated, common side effects include gastrointestinal issues, nasopharyngitis, and abdominal pain.

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

19.

Associated mood changes with naloxegol therapy for opioid-induced constipation in a patient with psychiatric disease.

Author: NagdaNeil, JavedSaba

Agitation
Confusion
Crying spells
Hysteria
Irritability
Mood lability

This clinical case report highlights unusual adverse effects of naloxegol therapy in a patient with pre-existing bipolar disorder. The patient experienced mood lability and profound psychiatric manifestations after taking naloxegol, which are not typically described as side effects by the drug manufacturer. Clinicians should be aware of these potential adverse effects when prescribing naloxegol to patients with psychiatric co-morbidities.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

Effectiveness of naloxegol in patients with cancer pain suffering from opioid-induced constipation.

Author: LemaireAntoine, PointreauYoann, NarcisoBérengère, PiloquetFrançois-Xavier, BranisteViorica, SabatéJean-Marc

OIC treatment
Quality of life

Naloxegol is a medication used to treat opioid-induced constipation. This study evaluated the effectiveness and safety of naloxegol in cancer patients experiencing constipation. The results showed that naloxegol was effective in improving constipation and overall quality of life in these patients.

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

Language : English

21.

Management of Opioid-Induced Constipation and Bowel Dysfunction: Expert Opinion of an Italian Multidisciplinary Panel.

Author: De GiorgioRoberto, ZuccoFurio Massimino, ChiarioniGiuseppe, MercadanteSebastiano, CorazziariEnrico Stefano, CaraceniAugusto, OdettiPatrizio, GiustiRaffaele, MarinangeliFranco, PintoCarmine

Opioid-induced constipation treatment
Breakthrough pain

Managing opioid-induced constipation (OIC) involves preventative measures and pharmacological treatment, with laxatives as first-line therapy and peripherally acting μ opioid receptor antagonists as second-line options.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Pharmacological characterization of naloxegol: In vitro and in vivo studies.

Author: CostanziniAnna, RuzzaChiara, NetoJoaquim Azevedo, SturaroChiara, MalfaciniDavide, SterniniCatia, De GiorgioRoberto, CalòGirolamo

Treat opioid-induced constipation

This study compared the pharmacological characteristics of naloxegol, a peripherally acting mu opioid receptor antagonist, to naloxone. Naloxegol effectively countered the constipating effects of fentanyl without interfering with its analgesic effects, suggesting its potential as a safe and effective treatment for opioid-induced constipation.

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.

Language : English

24.

One-year efficacy and safety of naloxegol on symptoms and quality of life related to opioid-induced constipation in patients with cancer: KYONAL study.

Author: Cobo DolsManuel, Beato ZambranoCarmen, Cabezón-GutiérrezLuis, Chicas-SettRodolfo, Blancas López-BarajasMaría Isabel, García NavalónFrancisco Javier, Fírvida PérezJosé Luis, Serrano BermúdezGala, Togores TorresPilar, Delgado MingoranceIgnacio, Giraldo MarínAlexandra, Librán OriolAnna, Paredes LarioAlfredo, Sánchez MauriñoPedro, Higuera GómezOliver, Moreno MuñozDiana, Huerta GonzálezIbone, Sanz-YagüeAlmudena, Soler LópezBegoña

Naloxegol efficacy
OIC treatment
Adverse events

Naloxegol, a peripherally acting µ-opioid receptor antagonist, was effective and safe in treating opioid-induced constipation (OIC) in patients with cancer over a 12-month period. Response rates were 77.8% at 12 months, with the most common adverse events being mild gastrointestinal symptoms.

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

Language : English

25.

Management of Opioid-Induced and Non-Opioid-Related Constipation in Patients With Cancer: Systematic Review and Meta-Analysis.

Author: GinexPamela K, HansonBrian J, LeFebvreKristine B, LinYufen, MoriartyKerri A, MaloneyChristine, VrabelMark, MorganRebecca L

Complementary approaches
Lifestyle management
Non-opioid constipation relief
Opioid constipation relief
Pharmacological management

For patients with cancer and opioid-induced constipation, osmotic or stimulant laxatives are moderately beneficial, while methylnaltrexone, naldemedine, and electroacupuncture offer small benefits. For non-opioid-related constipation, naloxegol, prucalopride, lubiprostone, and linaclotide show moderate benefits, while acupuncture has trivial benefit.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

26.

Acute opioid withdrawal syndrome from naloxone/naloxegol interaction.

Author: OlmoMontserrat, González-BarboteoJesús, MorenoDeborah, ComaEva, SerranoGala

Opioid withdrawal

A patient with cancer-related pain experienced acute opioid withdrawal symptoms after taking naloxegol, a peripherally acting mu-opioid receptor antagonist, in combination with naloxone. This highlights the potential for interactions between naloxone and naloxegol.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

27.

Naldemedine for the Use of Management of Opioid Induced Constipation.

Author: UritsIvan, PatelAnjana, KiernanHayley Cornwall, ClayConner Joseph, MonteferranteNikolas, JungJai Won, BergerAmnon A, KassemHisham, HasoonJamal, KayeAlan D, KayeAdam M, ViswanathOmar

Opioid-induced constipation treatment

This review focuses on the use of naldemedine, a medication used to treat opioid-induced constipation, a common side effect of opioid medications. The review provides background information, evidence supporting the drug's effectiveness, and indications for its use.

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

28.

Naloxegol rescue with methylnaltrexone highly effective.

Author: BrocklebankJenny, MillerElizabeth Jane, FingasSamuel

OIC management
Inadequate response

Naloxegol and methylnaltrexone are effective for opioid-induced constipation, but they may not work for all patients.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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