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Review

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

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Pages 1391-1400 | Published online: 09 Apr 2020

References

  • FordAC, LacyBE, TalleyNJ. Irritable bowel syndrome. N Engl J Med. 2017;376(26):2566–2578. doi:10.1056/NEJMra160754728657875
  • LovellRM, FordAC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712–721 e714. doi:10.1016/j.cgh.2012.02.02922426087
  • GralnekIM, HaysRD, KilbourneA, NaliboffB, MayerEA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology. 2000;119(3):654–660. doi:10.1053/gast.2000.1648410982758
  • FrandemarkA, TornblomH, JakobssonS, Work ProductivitySM. Activity Impairment in Irritable Bowel Syndrome (IBS): a multifaceted problem. Am J Gastroenterol. 2018;113(10):1540–1549. doi:10.1038/s41395-018-0262-x30254230
  • NgQX, SohAYS, LokeW, LimDY, YeoWS. The role of inflammation in irritable bowel syndrome (IBS). J Inflamm Res. 2018;11:345–349. doi:10.2147/JIR.S17498230288077
  • HoltmannGJ, FordAC, TalleyNJ. Pathophysiology of irritable bowel syndrome. Lancet Gastroenterol Hepatol. 2016;1(2):133–146. doi:10.1016/S2468-1253(16)30023-128404070
  • DrossmanDA. Functional gastrointestinal disorders: history, pathophysiology, clinical features and Rome IV. Gastroenterology. 2016;150:1262–1279.e2. doi:10.1053/j.gastro.2016.02.032
  • LacyBE, MearinF, ChangL, et al. Bowel disorders. Gastroenterology. 2016;150(6):1393. doi:10.1053/j.gastro.2016.02.031
  • LucakS, ChangL, HalpertA, HarrisLA. Current and emergent pharmacologic treatments for irritable bowel syndrome with diarrhea: evidence-based treatment in practice. Therap Adv Gastroenterol. 2017;10(2):253–275. doi:10.1177/1756283X16663396
  • HovdenakN. Loperamide treatment of the irritable bowel syndrome. Scand J Gastroenterol Suppl. 1987;130:81–84. doi:10.3109/003655287090910043306904
  • LavoB, StenstamM, NielsenA-L. Loperamide in treatment of irritable bowel syndrome–a double-blind placebo controlled study. Scand J Gastroenterol Suppl. 1987;22:77–80. doi:10.3109/00365528709091003
  • FordAC, MoayyediP, CheyWD, et al. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018;113(Suppl 2):1–18. doi:10.1038/s41395-018-0084-x
  • WagstaffAJ, OrmrodD, SpencerCM. Tianeptine: a review of its use in depressive disorders. CNS Drugs. 2001;15(3):231–259. doi:10.2165/00023210-200115030-0000611463130
  • SohnW, LeeOY, KwonJG, et al. Tianeptine vs amitriptyline for the treatment of irritable bowel syndrome with diarrhea: a multicenter, open-label, non-inferiority, randomized controlled study. Neurogastroenterol Motil. 2012;24(9):860–e398. doi:10.1111/j.1365-2982.2012.01945.x22679908
  • NgQX, SohAYS, LimDY, YeoWS. Agomelatine, a novel therapeutic option for the management of irritable bowel syndrome. J Clin Pharm Ther. 2018;43(5):752–756. doi:10.1111/jcpt.1274930014556
  • BalakinaIV, MironovaT, GolovanovaEN. [Efficacy and safety of valdoxan in patients with irritable bowel syndrome]. Zh Nevrol Psikhiatr Im S S Korsakova. 2014;114(4):90–92.
  • LewisJH. Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective. Expert Rev Gastroenterol Hepatol. 2010;4(1):13–29. doi:10.1586/egh.09.7220136586
  • TongK, NicandroJP, ShringarpureR, ChuangE, ChangL. A 9-year evaluation of temporal trends in alosetron postmarketing safety under the risk management program. Therap Adv Gastroenterol. 2013;6(5):344–357. doi:10.1177/1756283X13491798
  • US Food and Drug Administration. Highlights of prescribing information for lotronex (alosetron). FDA Label; 2008 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021107s013lbl.pdf. Accessed 123, 2019.
  • ChangL, LemboA, SultanS. American Gastroenterological Association Institute Technical Review on the pharmacological management of irritable bowel syndrome. Gastroenterology. 2014;147(5):1149–1172 e1142. doi:10.1053/j.gastro.2014.09.00225224525
  • KrauseR, AmeenV, GordonSH, et al. A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS. Am J Gastroenterol. 2007;102(8):1709–1719. doi:10.1111/ajg.2007.102.issue-817509028
  • LemboT, WrightRA, BagbyB, et al. Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. Am J Gastroenterol. 2001;96(9):2662–2670. doi:10.1111/j.1572-0241.2001.04128.x11569692
  • US Food and Drug Administration. Highlights of Prescribing Information for Xifaxan (rifaximin). FDA Label; 2017 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf. Accessed 123, 2019.
  • PimentelM, LemboA, CheyWD, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. New Engl J Med. 2011;364(1):22–32. doi:10.1056/NEJMoa100440921208106
  • LemboA, PimentelM, RaoSS, et al. Repeat treatment with rifaximin is safe and effective in patients with diarrhea-predominant irritable bowel syndrome. Gastroenterology. 2016;151(6):1113–1121. doi:10.1053/j.gastro.2016.08.00327528177
  • BarshopK, StallerK. Eluxadoline in irritable bowel syndrome with diarrhea: rationale, evidence and place in therapy. Ther Adv Chronic Dis. 2017;8(11):153–160. doi:10.1177/204062231771438929090081
  • US Food and Drug Administration. Highlights of prescribing information for viberzi (eluxadoline). FDA Label; 2018 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s006lbl.pdf. Accessed 123 2019.
  • HolzerP. Opioid receptors in the gastrointestinal tract. Regul Pept. 2009;155(1–3):11–17. doi:10.1016/j.regpep.2009.03.01219345246
  • WadePR, PalmerJM, McKenneyS, et al. Modulation of gastrointestinal function by MuDelta, a mixed mu opioid receptor agonist/mu opioid receptor antagonist. Brit J Pharmacol. 2012;167(5):1111–1125. doi:10.1111/j.1476-5381.2012.02068.x22671931
  • DoveLS, LemboA, RandallCW, et al. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013;145(2):329–338 e321. doi:10.1053/j.gastro.2013.04.00623583433
  • U.S. Food and. Drug Administration Center for Drug Evaluation and Research (CDER) In: Guidance for Industry, Irritable Bowel Syndrome — Clinical Evaluation of Drugs for Treatment; 5 2012.
  • LemboAJ, LacyBE, ZuckermanMJ, et al. Eluxadoline for irritable bowel syndrome with diarrhea. N Engl J Med. 2016;374(3):242–253. doi:10.1056/NEJMoa150518026789872
  • CheyWD, DoveLS, AndraeDA, CovingtonPS. Early response predicts a sustained response to eluxadoline in patients with irritable bowel syndrome with diarrhoea in two Phase 3 studies. Aliment Pharmacol Ther. 2017;45(10):1319–1328. doi:10.1111/apt.1403128326568
  • LacyBE, CheyWD, CashBD, LemboAJ, DoveLS, CovingtonPS. Eluxadoline efficacy in IBS-D patients who report prior loperamide use. Am J Gastroenterol. 2017;112(6):924–932. doi:10.1038/ajg.2017.7228417992
  • BrennerDM, SayukGS, GutmanCR, et al. Efficacy and safety of eluxadoline in patients with irritable bowel syndrome with diarrhea who report inadequate symptom control with loperamide: RELIEF Phase 4 study. Am J Gastroenterol. 2019;114:1502–1511. doi:10.14309/ajg.000000000000032731356229
  • BlackCJ, BurrNE, CamilleriM, et al. Efficacy of pharmacological therapies in patients with IBS with diarrhoea or mixed stool pattern: systematic review and network meta-analysis. Gut. 2019;69:74–82.30996042
  • CashBD, LacyBE, SchoenfeldPS, DoveLS, CovingtonPS. Safety of eluxadoline in patients with irritable bowel syndrome with diarrhea. Am J Gastroenterol. 2017;112(2):365–374. doi:10.1038/ajg.2016.54227922029
  • US Food and Drug Administration. FDA Drug Safety Communication: FDA Warns About Increased Risk of Serious Pancreatitis with Irritable Bowel Drug Viberzi (Eluxadoline) in Patients Without a Gallbladder. Center for Drug Evaluation and Research; 2017 Available from: https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm. Accessed 123, 2019.
  • GawronAJ, BielefeldtK. Risk of pancreatitis following treatment of irritable bowel syndrome with eluxadoline. Clin Gastroenterol Hepatol. 2018;16(3):378–384 e372. doi:10.1016/j.cgh.2017.08.00628804032
  • ChedidV, VijayvargiyaP, CamilleriM. Advantages and limitations of the federal adverse events reporting system in assessing adverse event reporting for eluxadoline. Clin Gastroenterol Hepatol. 2018;16(3):336–338. doi:10.1016/j.cgh.2017.11.02529155353
  • HarinsteinL, WuE, BrinkerA. Postmarketing cases of eluxadoline-associated pancreatitis in patients with or without a gallbladder. Aliment Pharmacol Ther. 2018;47(6):809–815. doi:10.1111/apt.1450429349789
  • AfghaniE, LoSK, CovingtonPS, CashBD, PandolSJ. Sphincter of Oddi function and risk factors for dysfunction. Front Nutr. 2017;4:1. doi:10.3389/fnut.2017.0000128194398
  • CroteauR, BarkinJS. Safety of Eluxadoline in patients with irritable bowel syndrome. Am J Gastroenterol. 2017;112(10):1616. doi:10.1038/ajg.2017.24928978966
  • DavenportJM, CovingtonP, BonifacioL, McIntyreG, VenitzJ. Effect of uptake transporters OAT3 and OATP1B1 and efflux transporter MRP2 on the pharmacokinetics of eluxadoline. J Clin Pharmacol. 2015;55(5):534–542. doi:10.1002/jcph.44225491493
  • FantRV, HenningfieldJE, CashBD, DoveLS, CovingtonPS. Eluxadoline demonstrates a lack of abuse potential in Phase 2 and 3 studies of patients with irritable bowel syndrome with diarrhea. Clin Gastroenterol Hepatol. 2017;15(7):1021–1029 e1026. doi:10.1016/j.cgh.2017.01.02628167156
  • Levy-CoopermanN, McIntyreG, BonifacioL, et al. Abuse potential and pharmacodynamic characteristics of oral and intranasal eluxadoline, a mixed mu- and kappa-opioid receptor agonist and delta-opioid receptor antagonist. J Pharmacol Exp Ther. 2016;359(3):471–481. doi:10.1124/jpet.116.23654727647873
  • LacyBE, HarrisLA, ChangL, et al. Impact of patient and disease characteristics on the efficacy and safety of eluxadoline for IBS-D: a subgroup analysis of phase III trials. Therap Adv Gastroenterol. 2019;12:1756284819841290. doi:10.1177/1756284819841290