Effects of eluxadoline: A Synthesis of Findings from 29 Studies

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Original Abstract of the Article

Main research findings

Eluxadoline is a medication approved by the Food and Drug Administration (FDA) for the treatment of irritable bowel syndrome with diarrhea (IBS-D). 11 Eluxadoline is a novel, locally acting mixed μ- and κ-opioid receptor agonist and δ-receptor antagonist, which means it works in the gut to reduce gut motility and reduce pain. 12 Studies have shown that eluxadoline can improve symptoms of IBS-D, such as abdominal pain and diarrhea. 16 19 The medication has been shown to improve quality of life for patients with IBS-D. 19 However, there are also risks associated with eluxadoline, including constipation, nausea, and abdominal pain. 11 It has also been found to cause a rare but serious adverse event, pancreatitis, especially in patients who have had their gallbladder removed. 28 14 25 11 Eluxadoline, as an opioid, has been linked to potential abuse and dependence. 1

Benefits and Risks

Benefit Summary

Eluxadoline has been shown to improve symptoms of IBS-D, such as abdominal pain and diarrhea. 16 19 It has also been shown to improve quality of life for patients with IBS-D. 19

Risk Summary

Eluxadoline can cause side effects such as constipation, nausea, and abdominal pain. 11 Patients who have had their gallbladder removed are at a higher risk for a rare but serious side effect, pancreatitis. 28 14 25 11 Eluxadoline, as an opioid, has been linked to potential abuse and dependence. 1

Study Comparisons

Commonalities among Studies

Many studies have found that eluxadoline can improve symptoms of IBS-D, such as abdominal pain and diarrhea. 19 16 Many of these studies also reported common side effects associated with eluxadoline, including constipation, nausea, and abdominal pain. 11

Differences among Studies

Some studies have focused on the safety of eluxadoline and found that patients who have had their gallbladder removed are at a higher risk of developing pancreatitis. 28 14 25 11 Other studies have focused on the potential for eluxadoline abuse and dependence. 1

Consistency and Contradictions in Results

Although many studies have shown the effectiveness of eluxadoline in improving IBS-D symptoms, some contradictory findings have emerged. 19 16 For instance, research has indicated that patients who have undergone gallbladder removal are at a heightened risk of developing pancreatitis. 28 14 25 11 Similarly, results regarding eluxadoline's abuse and dependence potential have shown inconsistencies. 1

Considerations for Real-World Application

If considering eluxadoline for IBS-D treatment, it is important to consult with a doctor. 11 Patients who have had their gallbladder removed should be aware of the increased risk of pancreatitis. 28 14 25 11 Also, given eluxadoline's classification as an opioid, be mindful of the potential for abuse and dependence. 1 Always follow your doctor's instructions for safe and effective use.

Limitations of Current Research

There is still much research to be done on eluxadoline. 10 13 20 7 For example, we need more studies to evaluate the long-term safety of the medication. 10 13 20 7 Also, keep in mind that the effects and safety of eluxadoline may vary from person to person. 6 15 23 15 22 8

Future Research Directions

More research is needed on the long-term safety of eluxadoline. 10 13 20 7 Given the potential variations in eluxadoline's effects and safety from person to person, research should focus on tailoring treatment to individual patient needs. 6 15 23 15 22 8

Conclusion

Eluxadoline is a potential treatment option for IBS-D, and may improve symptoms for some patients. 11 However, it is crucial to be aware of the potential risks, such as pancreatitis in patients who have had their gallbladder removed, and the possibility of abuse and dependence. 28 14 25 11 1 Always consult with your doctor to discuss the risks and benefits of eluxadoline and make informed decisions about your treatment.

Literature analysis of 29 papers
Positive Content
24
Neutral Content
3
Negative Content
2
Article Type
3
2
2
11
27
1.

Abuse Potential and Pharmacodynamic Characteristics of Oral and Intranasal Eluxadoline, a Mixed μ- and κ-Opioid Receptor Agonist and δ-Opioid Receptor Antagonist.

Author: Levy-CoopermanN, McIntyreG, BonifacioL, McDonnellM, DavenportJ M, CovingtonP S, DoveL S, SellersE M

Less abuse potential
Euphoric mood

Eluxadoline is a peripherally acting mixed μ-OR and κ-OR agonist and δ-OR antagonist that is approved in the United States for the treatment of irritable bowel syndrome with diarrhea. This study evaluated the oral and intranasal abuse potential of eluxadoline versus placebo and the active control oxycodone in recreational opioid users. The data demonstrate that eluxadoline has less abuse potential than oxycodone.

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

2.

Effects of treatment with eluxadoline on abdominal pain in patients with IBS-D: Additional post hoc analyses of Phase 3 trials.

Author: LemboAnthony J, CovingtonPaul S, DoveLeonard S, AndraeDavid A

Abdominal pain treatment

This study examined the effect of eluxadoline, a treatment for irritable bowel syndrome with diarrhea (IBS-D), on abdominal pain through various post hoc analyses.

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

Language : English

4.

An Open-Label Study to Evaluate the Effect of Eluxadoline on the Single-Dose Pharmacokinetics of Midazolam in Healthy Participants.

Author: BoinpallyRamesh, McGeeneyDanielle, KaczynskiEdward, WeissmanDarren

Eluxadoline, a mixed opioid receptor agonist and antagonist, did not demonstrate clinically significant drug interactions with midazolam, a cytochrome P450 3A4 substrate.

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

5.

Eluxadoline Versus Antispasmodics in the Treatment of Irritable Bowel Syndrome: An Adjusted Indirect Treatment Comparison Meta-analysis.

Author: QinDi, TaoQing-Feng, HuangShi-Le, ChenMin, ZhengHui

IBS pain relief
Adverse events

This study compares the effectiveness of eluxadoline with antispasmodics for irritable bowel syndrome, finding that eluxadoline 100 mg was at least as effective as antispasmodics in relieving abdominal pain, but had more reported adverse events, suggesting that antispasmodics remain the first-line treatment option.

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

6.

Safety and Efficacy of Eluxadoline in Patients with Irritable Bowel Syndrome-Diarrhea With or Without Bile Acid Diarrhea: Open-Label Study.

Author: VijayvargiyaPriya, Breen-LylesMargaret, NordSara Linker, MaselliDaniel, BusciglioIrene, BoinpallyRamesh, MuslinAnna, CarrothersTimothy J, CamilleriMichael

BAD treatment
IBS-D treatment

Eluxadoline is similarly efficacious in the treatment of irritable bowel syndrome-diarrhea (IBS-D) and bile acid diarrhea (BAD). The drug was safe and well-tolerated.

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

Diarrhea-Predominant and Constipation-Predominant Irritable Bowel Syndrome: Current Prescription Drug Treatment Options.

Author: WechslerEmily V, ShahEric D

IBS symptom relief

This review summarizes the clinical profiles of efficacy, safety, and tolerability of prescription drugs for irritable bowel syndrome (IBS), including cost-effectiveness of drugs for diarrhea-predominant IBS and constipation-predominant IBS.

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

8.

Efficacy of opioid receptor modulators in patients with irritable bowel syndrome: A systematic review and meta-analysis.

Author: LiXia, LiBo, ZhangJiaqi, ChenTing, WuHaomeng, ShiXiaoshuang, MaJinxin, QinJinyan, TangXudong, WangFengyun

IBS treatment
Potential for IBS symptom relief
Needs further research
Unclear effects of opioid modulators

This study aims to determine whether medications that affect opioid receptors in the body can help improve symptoms of irritable bowel syndrome (IBS). IBS is a common digestive disorder that can significantly impact people's lives, and this study seeks to find potential treatments by examining the role of opioid receptors in gut function.

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

10.

An update on efficacy and safety considerations for the latest drugs used to treat irritable bowel syndrome.

Author: MousaviTaraneh, NikfarShekoufeh, AbdollahiMohammad

Irritable bowel syndrome (IBS) affects 11.2% of the global population and poses a significant therapeutic challenge. More research is needed to evaluate the tolerability and efficacy of available medications for IBS.

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

11.

Update on Eluxadoline for the Treatment of Irritable Bowel Syndrome with Diarrhea: Patient Selection and Perspectives.

Author: LiuRebecca, StallerKyle

IBS-D treatment
Abdominal pain
Constipation
Nausea
Pancreatitis

Eluxadoline, a novel drug for diarrhea-predominant irritable bowel syndrome (IBS-D), showed efficacy in clinical trials. However, it carries risks of sphincter of Oddi spasm and pancreatitis, particularly in patients without a gallbladder.

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

12.

Mu and Delta Opioid Receptors Are Coexpressed and Functionally Interact in the Enteric Nervous System of the Mouse Colon.

Author: DiCelloJesse J, CarboneSimona E, SaitoAyame, RajasekharPradeep, CeredigRhian A, PhamVi, ValantCeline, ChristopoulosArthur, VeldhuisNicholas A, CanalsMeritxell, MassotteDominique, PooleDaniel P

Analgesic development

This study characterized the distribution of the mu opioid receptor (MOR) in the mouse enteric nervous system (ENS) and examined interactions with the delta opioid receptor (DOR). The findings have implications for the development of novel analgesics and for understanding the mechanism of eluxadoline, a drug used for diarrhea-predominant irritable bowel syndrome.

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

13.

Current US Food and Drug Administration-Approved Pharmacologic Therapies for the Treatment of Irritable Bowel Syndrome with Diarrhea.

Author: BrennerDarren M, SayukGregory S

IBS-D treatment

This review highlights the efficacy and safety of three pharmacologic agents approved for treating irritable bowel syndrome with diarrhea (IBS-D) in adults: rifaximin, eluxadoline, and alosetron.

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

14.

Eluxadoline-induced pancreatitis occurring in an adult man without a prior cholecystectomy.

Author: ShahidZainab, PackardElizabeth, GroffAndrew, JainRohit

Eluxadoline-induced pancreatitis

A case of eluxadoline-induced pancreatitis was reported in an adult man without prior cholecystectomy.

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

15.

Small intestinal microbial dysbiosis underlies symptoms associated with functional gastrointestinal disorders.

Author: SaffouriGeorge B, Shields-CutlerRobin R, ChenJun, YangYi, LekatzHeather R, HaleVanessa L, ChoJanice M, BattaglioliEric J, BhattaraiYogesh, ThompsonKevin J, KalariKrishna K, BeheraGaurav, BerryJonathan C, PetersStephanie A, PatelRobin, SchuetzAudrey N, FaithJeremiah J, CamilleriMichael, SonnenburgJustin L, FarrugiaGianrico, SwannJonathan R, GroverMadhusudan, KnightsDan, KashyapPurna C

Diet-based treatment
Targeted treatment

Small intestinal bacterial overgrowth (SIBO) is a condition where bacteria in the small intestine grow too much. It is thought to contribute to symptoms of functional gastrointestinal disorders (FGIDs), but the exact mechanisms are unknown. This study found that SIBO, as diagnosed by duodenal aspirate culture, does not always correspond with patient symptoms and may be influenced by diet. Instead, changes in the composition of small intestinal microbes were associated with symptoms. A pilot study showed that switching from a high-fiber diet to a low-fiber, high-sugar diet triggered FGID symptoms, reduced microbial diversity, and increased intestinal permeability. These findings suggest that targeting the specific microbial composition of the small intestine may be more effective than general antibiotic treatment for FGIDs.

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.
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

16.

Efficacy of pharmacological therapies in patients with IBS with diarrhoea or mixed stool pattern: systematic review and network meta-analysis.

Author: BlackChristopher J, BurrNicholas E, CamilleriMichael, EarnestDavid L, QuigleyEamonn Mm, MoayyediPaul, HoughtonLesley A, FordAlexander C

Abdominal pain reduction
IBS-D improvement
IBS-M improvement
Adverse events
Constipation

Alosetron 1 mg twice daily was ranked first for efficacy and ramosetron 2.5µg once daily was ranked first for effect on abdominal pain in the treatment of IBS-D or IBS-M. Rifaximin 550 mg three times daily ranked first for safety.

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

18.

Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use, health-related quality of life, safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome.

Author: OldenKevin W, CheyWilliam D, ShringarpureReshma, Paul NicandroJean, ChuangEmil, EarnestDavid L

IBS-D treatment
Improved HRQOL
Reduced healthcare costs

This study compared the treatment outcomes of alosetron versus traditional pharmacotherapy (TP) in women with severe diarrhea-predominant irritable bowel syndrome (IBS-D). The study found that alosetron was associated with improved resource use, work productivity, health-related quality of life, and global symptom response compared to TP.

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

Language : English

20.

Review article: an analysis of safety profiles of treatments for diarrhoea-predominant irritable bowel syndrome.

Author: LacyBrian E

Reduced IBS symptoms
Cardiac adverse events
Constipation
Ischemic colitis
Pancreatitis

Multiple treatment options are available for patients with diarrhea-predominant IBS, but their safety profiles vary widely.

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.

Methylation Products of 6β- N-Heterocyclic Substituted Naltrexamine Derivatives as Potential Peripheral Opioid Receptor Modulators.

Author: ZhengYi, ObengSamuel, WangHuiqun, StevensDavid L, KomlaEssie, SelleyDana E, DeweyWilliam L, AkbaraliHamid I, ZhangYan

Bowel dysfunction
Treat diarrhea

This study investigates two novel peripherally selective mu opioid receptor (MOR) antagonists, dMNAP and dMNMP. These compounds act as moderate efficacy partial agonists and show promise for treating diarrhea in patients with bowel dysfunction.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

23.

Acupuncture for Diarrhoea-Predominant Irritable Bowel Syndrome: A Network Meta-Analysis.

Author: ZhuLingping, MaYunhui, YeShasha, ShuZhiqun

Fewer side effects
Improved IBS symptoms

Acupuncture was found to be more effective than drugs and sham acupuncture in treating diarrhea-predominant irritable bowel syndrome, with the fewest side effects.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

25.

Eluxadoline-Associated Pancreatitis in a Post-Cholecystectomy Patient: A Case Report.

Author: ChhapariaAnuj, HammamiMuhammad B, VareedayahAshley, SchroederKatie

Eluxadoline efficacy
Eluxadoline pancreatitis
Eluxadoline side effects

A patient with eluxadoline-induced pancreatitis is described, the first case we know of to be reported outside of phase III clinical trials.

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.

Evaluation of Eluxadoline Effect on Cardiac Repolarization.

Author: BonifacioLaura, HuntThomas L, McIntyreGail, DoveLeonard S, CovingtonPaul S

Safe and well-tolerated
Contact dermatitis
Dizziness
Nausea

Eluxadoline, a drug used to treat irritable bowel syndrome, does not significantly prolong QT intervals, making it a safe and well-tolerated option for patients.

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

27.

Advancements in drug development for diarrhea-predominant irritable bowel syndrome.

Author: DothelGiovanni, BarbaroMaria Raffaella, RaschiEmanuel, BarbaraGiovanni, De PontiFabrizio

IBS-D symptom relief

5-HT3 receptor antagonists are effective for treatment of IBS-D.

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.

Postmarketing cases of eluxadoline-associated pancreatitis in patients with or without a gallbladder.

Author: HarinsteinL, WuE, BrinkerA

Pancreatitis

The study found that patients with or without a gallbladder receiving eluxadoline are at risk for the development of pancreatitis.

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

Language : English

29.

Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome.

Author: ÖzdenerAyşe Elif, RivkinAnastasia

IBS-D treatment
Pancreatitis

Eluxadoline is a novel drug approved for the management of diarrhea-predominant irritable bowel syndrome (IBS-D). While it has shown efficacy in reducing IBS-D symptoms, a risk of pancreatitis exists in patients without a gallbladder or those who abuse alcohol.

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

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