Effects of naldemedine: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Major Research Findings

Naldemedine is a peripherally acting μ-opioid receptor antagonist developed to improve opioid-induced constipation (OIC). 22 , 6 , 11 , 8 , 16 . It works by blocking opioid receptors in the gut, which helps to relieve constipation without affecting the pain-relieving effects of opioids. 11 . Several studies have shown that naldemedine is more effective than placebo in treating OIC, leading to increased bowel movement frequency, improved quality of life, and reduced constipation-related symptoms. 8 , 3 , 18 . Naldemedine is generally safe and well-tolerated, with the most common side effects being gastrointestinal, such as diarrhea, abdominal pain, and vomiting. 11 , 8 . However, a case report suggests that naldemedine might cause opioid withdrawal syndrome in patients with breast cancer, even without brain metastasis. 7 . Clinical trials have primarily focused on naldemedine use in patients with good performance status (PS), but real-world use extends to patients with poorer PS. 22 . Several studies have assessed naldemedine efficacy in patients with poor PS, finding similar effectiveness compared to those with good PS. 5 .

Benefits and Risks

Benefit Summary

Naldemedine has been shown to be more effective than placebo in treating OIC. 8 , 3 , 18 . This improvement leads to increased bowel movement frequency, improved quality of life, and reduced constipation-related symptoms. 8 , 3 , 18 . Naldemedine doesn't interfere with the pain-relieving effects of opioids or cause withdrawal symptoms. 11 . Naldemedine is generally safe and well-tolerated and may be a more effective and safer alternative to traditional laxatives. 10 .

Risk Summary

The most common side effects of naldemedine are gastrointestinal, such as diarrhea, abdominal pain, and vomiting. 11 , 8 . A case report suggests that naldemedine might cause opioid withdrawal syndrome in patients with breast cancer, even without brain metastasis. 7 .

Comparison of Studies

Similarities

Multiple studies have confirmed naldemedine's effectiveness in managing OIC. 22 , 6 , 11 , 8 , 16 . These studies consistently show that naldemedine is more effective than placebo in treating OIC. 8 , 3 , 18 . All studies also agree that naldemedine is generally safe and well-tolerated. 11 , 8 .

Differences

The studies differ in terms of the study population and the methods used to evaluate naldemedine's effectiveness. 22 , 6 , 11 , 8 , 16 . For instance, 22 focuses on patients with poor PS. 5 compares the effectiveness of naldemedine in patients with good and poor PS.

Consistency and Contradictions

While naldemedine's effectiveness is consistently confirmed by multiple studies, there is a need for further research on its effectiveness in patients with poor PS. 22 , 5 . There is also a potential contradiction as one case report suggests that naldemedine might cause opioid withdrawal syndrome in patients with breast cancer, even without brain metastasis. 7 .

Real-world Application Notes

Naldemedine appears to be a promising option for treating OIC. 10 . However, it is crucial to remember that naldemedine may not be effective for everyone, and the risk of side effects should be considered. 11 , 8 . Always follow your doctor's instructions when using naldemedine.

Limitations of Current Research

There is still a lack of sufficient research on naldemedine. 22 . Further research is needed to assess the effectiveness of naldemedine in patients with poor PS. 5 . Long-term safety studies and investigations into the combination of naldemedine with other treatments are also necessary. 3 .

Future Research Directions

Future research should focus on confirming naldemedine's effectiveness in patients with poor PS. 22 , 5 . Further investigation is also necessary to explore the long-term safety of naldemedine and its use in combination with other treatments. 3 .

Conclusion

Naldemedine has demonstrated significant effectiveness in treating OIC compared to placebo. 8 , 3 , 18 . It appears to be a safe and well-tolerated option, potentially offering a more effective and safer alternative to traditional laxatives. 10 . However, it's important to remember that naldemedine might not work for everyone and carries potential side effects. Always consult with your doctor before starting any new medication, including naldemedine.

Literature analysis of 28 papers
Positive Content
25
Neutral Content
1
Negative Content
2
Article Type
1
2
2
11
28
1.

[A New Twist on the Administration of Naldemedine for Opioid-Induced Constipation in an Outpatient].

Author: ShikadaYasunori, EmiYasunori, KometaniTakuro, OchiaiToshiaki, FujiiMisa, NodaYoko, KajiwaraMie, IkedaMunehiko, AsonumaShinichi, MoriMinami

Alleviate diarrhea
Improved bowel habits
Diarrhea

Opioid-induced constipation (OIC) is a common problem for cancer patients undergoing opioid treatment. Naldemedine has emerged as a new treatment option for OIC, but concerns about diarrhea remain. This report describes the use of naldemedine to alleviate diarrhea and improve bowel habits in outpatients with cancer.

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

Language : Japanese

2.

Efficacy of Treatments for Opioid-Induced Constipation: Systematic Review and Meta-analysis.

Author: NeeJudy, ZakariMohammed, SugarmanMichael A, WhelanJulia, HirschWilliam, SultanShahnaz, BallouSarah, IturrinoJohanna, LemboAnthony

OIC treatment

Naloxegol and naldemedine are two new agents approved for treatment of opioid-induced constipation (OIC).

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

3.

Long-term use of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: a randomized, double-blind, placebo-controlled phase 3 study.

Author: WebsterLynn R, NalamachuSrinivas, MorlionBart, ReddyJyotsna, BabaYuko, YamadaTadaaki, Arjona FerreiraJuan C

Opioid-induced constipation
Quality of life
Diarrhea

Naldemedine, a peripherally acting µ-opioid receptor antagonist, was found to be safe and well-tolerated in patients with opioid-induced constipation and chronic noncancer pain over 52 weeks. The most common side effect was diarrhea, reported in 11% of patients taking naldemedine compared to 5.3% of those taking placebo. Naldemedine did not interfere with opioid-mediated analgesia or precipitate opioid withdrawal. It significantly increased bowel movement frequency, improved constipation-related symptoms, and increased patients' quality of life compared to placebo.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

4.

Clinical Overview and Considerations for the Management of Opioid-induced Constipation in Patients With Chronic Noncancer Pain.

Author: ViscusiEugene R

Opioid-induced constipation

Prescription medications for opioid-induced constipation (OIC) include peripherally acting µ-opioid receptor antagonists (PAMORA) and chloride channel activators. These medications are effective for improving OIC in patients with chronic noncancer pain, but potential gastrointestinal side effects need to be considered.

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.

[Efficacy Survey of Naldemedine in the Poor-performance Status Group].

Author: KatoShintaro, SaitoYoshitaka, OnodaHiroko, KumaiMasayoshi, ImaiShungo, TsurugaKenkichi, TakekumaYoh, SugawaraMitsuru

Naldemedine for constipation

This retrospective study evaluated the efficacy of naldemedine in treating opioid-induced constipation in cancer patients with poor performance status. The results suggest that naldemedine is similarly effective in patients with poor and good performance status.

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 : Japanese

6.

Pharmacologic effects of naldemedine, a peripherally acting μ-opioid receptor antagonist, in in vitro and in vivo models of opioid-induced constipation.

Author: KanemasaToshiyuki, KoikeKatsumi, AraiTohko, OnoHiroko, HoritaNarumi, ChibaHiroki, NakamuraAtsushi, MoriokaYasuhide, KiharaTsuyoshi, HasegawaMinoru

Opioid analgesia
Reduced OIC

Naldemedine, a peripherally acting μ-opioid receptor antagonist, showed potent binding affinity to and antagonistic activity against μ-, δ-, and κ-opioid receptors. It effectively reduced opioid-induced constipation in vivo without compromising opioid analgesia.

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.

Naldemedine-induced Opioid Withdrawal Syndrome in a Patient with Breast Cancer without Brain Metastasis.

Author: IshiiKoji, YamashitaHaruna, YamaguchiMidori, KomatsuYuya, RyuEmi, MorishitaSatoru, MatsuoKumi, KamadaMasatsugu, IkedaTsunako, AshizawaKazuto, HaraTetsuya

OIC treatment
Opioid withdrawal syndrome

This case report describes a 52-year-old female who developed opioid withdrawal syndrome (OWS) after taking naldemedine for opioid-induced-constipation (OIC).

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

8.

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

9.

Naldemedine for the treatment of opioid-induced constipation in adults with chronic noncancer pain.

Author: LiuJoy J, QuintonSarah E, BrennerDarren M

Constipation relief
Safe treatment
Abdominal pain
Diarrhea

Naldemedine, a peripherally acting μ-opioid receptor antagonist (PAMORA), showed significant efficacy in Phase III trials for the treatment of opioid-induced constipation in adults with chronic noncancer 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

10.

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

12.

Evidence Based Review of Pharmacotherapy for Opioid-Induced Constipation in Noncancer Pain.

Author: MurphyJulie A, SheridanErica A

Constipation relief
Opioid side effects

Methylnaltrexone, naloxegol, and naldemedine may be appropriate to treat opioid-induced constipation in patients with chronic noncancer pain. Data suggest that these medications are effective and safe.

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

13.

Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care.

Author: CandyBridget, JonesLouise, VickerstaffVictoria, LarkinPhilip J, StonePatrick

OIBD management

Mu-opioid antagonists (MOAs), including methylnaltrexone, are used for the management of opioid-induced bowel dysfunction (OIBD) in people with cancer and people receiving palliative care.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

14.

Discovery of naldemedine: A potent and orally available opioid receptor antagonist for treatment of opioid-induced adverse effects.

Author: InagakiMasanao, KumeMasaharu, TamuraYoshinori, HaraShinichiro, GotoYoshihisa, HagaNobuhiro, HasegawaTsuyoshi, NakamuraTakashi, KoikeKatsumi, OonishiShuuichi, KanemasaToshiyuki, KaiHiroyuki

Reduced emesis/vomiting
Reduced opioid-induced constipation

Peripherally restricted dual antagonists for μ/δ-opioid receptors were discovered that inhibit opioid-induced constipation and emesis/vomiting with limited potential to interfere with the analgesic effects of morphine. Naldemedine was selected as a potential drug candidate.

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

Language : English

15.

A retrospective study of the efficacy and safety of naldemedine for opioid-induced constipation in thoracic cancer patients.

Author: ImaiHisao, FujitaYukiyoshi, HirutaEriko, MasunoTakashi, YamazakiShigeki, TanakaHajime, KamiyaTeruhiko, SandohMitsuru, TakeiSatoshi, AraiKazuya, NishibaHiromi, MogiJunnosuke, KairaKyoichi, MinatoKoichi

Improved opioid tolerance
Increased defecation
Diarrhea
Mild adverse events

Naldemedine was effective and feasible for most thoracic cancer patients, with a comparable efficacy and safety profile to that observed in prospective studies.

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.

Language : English

17.

Use of naldemedine is associated with reduced incidence of hyperactive delirium in cancer patients with opioid-induced constipation: A nationwide retrospective cohort study in Japan.

Author: AbeHiroaki, SumitaniMasahiko, MatsuiHiroki, InoueReo, FushimiKiyohide, UchidaKanji, YasunagaHideo

Hyperactive delirium

Naldemedine is a peripherally acting mu-opioid receptor antagonist primarily used for opioid-induced constipation. This study aimed to assess the association between naldemedine use and the incidence of hyperactive delirium in cancer patients receiving chemotherapy and opioid therapy.

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

18.

Spotlight on naldemedine in the treatment of opioid-induced constipation in adult patients with chronic noncancer pain: design, development, and place in therapy.

Author: SternEmily K, BrennerDarren M

Effective
OIC treatment
Safe
Abdominal pain
Diarrhea

Naldemedine is a peripherally acting μ-opioid receptor antagonist (PAMORA) approved for treating opioid-induced constipation (OIC). This review summarizes the literature on naldemedine, highlighting its effectiveness and safety in adults with chronic noncancer 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

20.

Possible mechanism for improving the endogenous immune system through the blockade of peripheral μ-opioid receptors by treatment with naldemedine.

Author: GondohEizoh, HamadaYusuke, MoriTomohisa, IwazawaYusuke, ShinoharaAsami, NaritaMichiko, SatoDaisuke, TezukaHiroyuki, YamauchiTakayasu, TsujimuraMayu, YoshidaSara, TanakaKenichi, YamashitaKensuke, AkatoriHaruka, HigashiyamaKimio, ArakawaKazuhiko, SudaYukari, MiyanoKanako, IsekiMasako, InadaEiichi, KuzumakiNaoko, NaritaMinoru

Improved immune function
Tumor regression

Systemic administration of the peripheral μ-opioid receptor (MOR) antagonist naldemedine significantly decreased tumor volume and prolonged survival in tumor-bearing mice. Naldemedine may induce an anti-tumor effect by recovering T-cell exhaustion and promoting the tumor-killing system.

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

21.

The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Naldemedine.

Author: FukumuraKazuya, YamadaTadaaki, YokotaTakaaki, KawasakiAkira

Opioid-induced constipation

Naldemedine, a peripherally acting μ-opioid-receptor antagonist for the treatment of opioid-induced constipation, does not require dose adjustments for subjects with renal impairment or mild or moderate hepatic impairment. The drug was well tolerated in both healthy subjects and subjects with renal or hepatic impairment.

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

Language : English

22.

Real-World Patient Characteristics and Treatment Patterns of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Cancer: A Multicenter Retrospective Chart Review Study.

Author: HirutaEriko, FujitaYukiyoshi, ImaiHisao, MasunoTakashi, YamazakiShigeki, TanakaHajime, KamiyaTeruhiko, ItoMasako, TakeiSatoshi, MatsuuraMasato, NishibaHiromi, MogiJunnosuke, KotakeMie, KoizukaShiro, MinatoKoichi

Opioid-induced constipation treatment
Abdominal pain
Diarrhea

Naldemedine, a peripherally acting μ-opioid receptor antagonist, effectively treats opioid-induced constipation. This retrospective study investigated the real-world use of naldemedine in opioid-treated cancer patients, including those with poor performance status and those starting naldemedine early after opioid initiation. The study found that naldemedine was well-tolerated and effective in clinical practice, even in populations not included in clinical trials, suggesting its potential for broader use in managing opioid-induced constipation.

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.

Language : English

24.

Naldemedine-induced opioid withdrawal syndrome with severe psychiatric symptoms in an advanced cervical cancer patient without brain metastasis.

Author: IshidaMayumi, HiraokaMie, YaguchiAyako, SuganoKoji, AdachiNasako, ItogaTomoko, IshiguroTomohito, OnishiHideki

Constipation treatment

Naldemedine, an oral peripheral μ-opioid receptor antagonist, was developed to treat constipation, a side effect of opioid use. Naldemedine does not typically cause opioid withdrawal symptoms affecting the central nervous system.

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

26.

Rationale and design of a multicenter, double-blinded, randomized, placebo-controlled trial to investigate the effects of naldemedine on opioid-induced constipation for patients with cancer pain: A study protocol.

Author: HigashibataTakahiro, HamanoJun, KessokuTakaomi, KajiuraShinya, HirakawaMami, HorieYoshiki, ShimizuMasaki, OyamadaShunsuke, AriyoshiKeisuke, KiharaKota, YamanakaYohei, KonishiKumi, DokiKosuke, TakashimaYasuyuki, HoriuchiManabu, HommaMasato, YamadaTakeshi, YamamotoYoshiyuki, MoriwakiToshikazu, MoritaTatsuya, NakajimaAtsushi, NagaokaHiroka

Prevent OIC

A multicenter, double-blinded, randomized, placebo-controlled trial is being conducted to assess the efficacy of naldemedine in preventing opioid-induced constipation (OIC) in patients with cancer. Naldemedine may become a new standard for OIC prophylaxis at opioid initiation.

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

Language : English

27.

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

28.

Involvement of the Peripheral μ-Opioid Receptor in Tramadol-Induced Constipation in Rodents.

Author: YasufukuKana, KoikeKatsumi, KobayashiMika, ChibaHiroki, KitauraMotoji, TakenouchiShino, HasegawaMinoru, MoriokaYasuhide, MishimaHirokazu, SuzukiTsutomu, FujitaMasahide

analgesic effect
constipation risk

This study found that peripheral MOR participates in tramadol-induced constipation.

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

Language : English

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