40
Views
0
CrossRef citations to date
0
Altmetric
Review

Pharmacokinetic considerations for drugs that treat diarrhea-predominant irritable bowel syndrome: what’s new?

ORCID Icon, ORCID Icon & ORCID Icon
Pages 307-317 | Received 18 Dec 2023, Accepted 24 Apr 2024, Published online: 02 May 2024

References

  • Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712–21.e4. doi: 10.1016/j.cgh.2012.02.029
  • Lembo A, Sultan S, Chang L, et al. AGA clinical practice guideline on the pharmacological management of irritable bowel syndrome with diarrhea. Gastroenterology. 2022;163(1):137–151. doi: 10.1053/j.gastro.2022.04.017
  • Huang KY, Wang FY, Lv M, et al. Irritable bowel syndrome: epidemiology, overlap disorders, pathophysiology and treatment. World J Gastroenterol. 2023;29(26):4120–4135. doi: 10.3748/wjg.v29.i26.4120
  • Buono JL, Carson RT, Flores NM. Health-related quality of life, work productivity, and indirect costs among patients with irritable bowel syndrome with diarrhea. Health Qual Life Outcomes. 2017;15(1):35. doi: 10.1186/s12955-017-0611-2
  • Maxion-Bergemann S, Thielecke F, Abel F, et al. Costs of irritable bowel syndrome in the UK and US. PharmacoEconomics. 2006;24(1):21–37. doi: 10.2165/00019053-200624010-00002
  • Nellesen D, Yee K, Chawla A, et al. A systematic review of the economic and humanistic burden of illness in irritable bowel syndrome and chronic constipation. J Manag Care Pharm. 2013;19(9):755–764. doi: 10.18553/jmcp.2013.19.9.755
  • Mousavi T, Nikfar S, Abdollahi M. An update on efficacy and safety considerations for the latest drugs used to treat irritable bowel syndrome. Expert Opin Drug Metab Toxicol. 2020;16(7):583–604. doi: 10.1080/17425255.2020.1767067
  • Mozaffari S, Nikfar S, Abdollahi M. Metabolic and toxicological considerations for the latest drugs used to treat irritable bowel syndrome. Expert Opin Drug Metab Toxicol. 2013;9(4):403–421. doi: 10.1517/17425255.2013.759558
  • Brenner DM, Sayuk GS. Current US food and drug administration-approved pharmacologic therapies for the treatment of irritable bowel syndrome with diarrhea. Adv Ther. 2020;37(1):83–96. doi: 10.1007/s12325-019-01116-z
  • Hanauer SB. The role of loperamide in gastrointestinal disorders. Rev Gastroenterol Disord. 2008;8(1):15–20.
  • Zheng Y, Yu T, Tang Y, et al. Efficacy and safety of 5-hydroxytryptamine three receptor antagonists in irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials. PLOS ONE. 2017;12(3):e0172846. doi: 10.1371/journal.pone.0172846
  • Li X, Li B, Zhang J, et al. Efficacy of opioid receptor modulators in patients with irritable bowel syndrome: a systematic review and meta-analysis. Medicine (Baltimore). 2021;100(4):e24361. doi: 10.1097/MD.0000000000024361
  • Eluxadoline FDA label [Internet]. 2018. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206940s003lbl.pdf
  • Liu R, Staller K. Update on eluxadoline for the treatment of irritable bowel syndrome with diarrhea: patient selection and perspectives. Drug Des Devel Ther. 2020;14:1391–1400. doi: 10.2147/DDDT.S216056
  • Lembo AJ, Lacy BE, Zuckerman MJ, et al. Eluxadoline for irritable bowel syndrome with diarrhea. N Engl J Med. 2016;374(3):242–253. doi: 10.1056/NEJMoa1505180
  • Özdener AE, Rivkin A. Eluxadoline in treating diarrhea-predominant irritable bowel syndrome. Drug Des Devel Ther. 2017;11:2827–2840. doi: 10.2147/DDDT.S127405
  • Abel JL, Carson RT, Andrae DA. The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea. Qual Life Res. 2019;28(2):369–377. doi: 10.1007/s11136-018-2008-z
  • Brenner DM, Sayuk GS, Gutman CR, 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(9):1502–1511. doi: 10.14309/ajg.0000000000000327
  • Boinpally R, Weissman D. Single-dose pharmacokinetics of eluxadoline in healthy participants with normal renal function and participants with renal impairment. Clin Pharmacol Drug Dev. 2023;12(2):132–140. doi: 10.1002/cpdd.1204
  • Maruca A, Lupia A, Rocca R, et al. In silico food-drug interaction: a case study of eluxadoline and fatty meal. Int J Mol Sci. 2020;21(23):9127. doi: 10.3390/ijms21239127
  • Cash BD, Lacy BE, Schoenfeld PS, et al. Safety of eluxadoline in patients with irritable bowel syndrome with diarrhea. Am J Gastroenterol. 2017;112(2):365–374. doi: 10.1038/ajg.2016.542
  • Fant RV, Henningfield JE, Cash BD, et al. 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):1021–9.e6. doi: 10.1016/j.cgh.2017.01.026
  • Levy-Cooperman N, McIntyre G, Bonifacio L, et al. Abuse potential and pharmacodynamic characteristics of oral and intranasal eluxadoline, a mixed μ- and K-opioid receptor agonist and δ-opioid receptor antagonist. J Pharmacol Exp Ther. 2016;359(3):471–481. doi: 10.1124/jpet.116.236547
  • Saps M, Miranda A. Gastrointestinal pharmacology. Handb Exp Pharmacol. 2017;239:147–176.
  • Marbury TC, Berg JK, Dove LS, et al. Effect of hepatic impairment on eluxadoline pharmacokinetics. J Clin Pharmacol. 2017;57(11):1454–1459. doi: 10.1002/jcph.964
  • Davenport JM, Covington P, Bonifacio L, et al. 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.442
  • Mozaffari S, Mousavi T, Nikfar S, et al. Common gastrointestinal drug-drug interactions in geriatrics and the importance of careful planning. Expert Opin Drug Metab Toxicol. 2023;19(11):807–828. doi: 10.1080/17425255.2023.2273384
  • Gershon MD. Serotonin and its implication for the management of irritable bowel syndrome. Rev Gastroenterol Disord. 2003;3(Suppl 2):S25–34.
  • Spiller R. Recent advances in understanding the role of serotonin in gastrointestinal motility in functional bowel disorders: alterations in 5-HT signalling and metabolism in human disease. Neurogastroenterol Motil. 2007;19(Suppl 2):25–31. doi: 10.1111/j.1365-2982.2007.00965.x
  • Olden KW, Chey WD, Shringarpure R, et al. 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. Curr Med Res Opin. 2019;35(3):461–472. doi: 10.1080/03007995.2018.1533456
  • Lembo A, Ameen VZ, Drossman DA. Irritable bowel syndrome: toward an understanding of severity. Clin Gastroenterol Hepatol. 2005;3(8):717–725. doi: 10.1016/S1542-3565(05)00157-6
  • Rahimi R, Nikfar S, Abdollahi M. Efficacy and tolerability of alosetron for the treatment of irritable bowel syndrome in women and men: a meta-analysis of eight randomized, placebo-controlled, 12-week trials. Clin Ther. 2008;30(5):884–901. doi: 10.1016/j.clinthera.2008.05.002
  • Alosetron FDA label [Internet]. 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021107s029lbl.pdf
  • Butt I, Alosetron KF. StatPearls. Treasure Island (FL): StatPearls Publishing Copyright © 2023, StatPearls Publishing LLC.; 2023.
  • Koch KM, Corrigan BW, Manzo J, et al. Alosetron repeat dose pharmacokinetics, effects on enzyme activities, and influence of demographic factors. Aliment Pharmacol Ther. 2004;20(2):223–230. doi: 10.1111/j.1365-2036.2004.02031.x
  • Koch KM, Palmer JL, Noordin N, et al. Sex and age differences in the pharmacokinetics of alosetron. Br J Clin Pharmacol. 2002;53(3):238–242. doi: 10.1046/j.0306-5251.2001.01565.x
  • Lacy BE. Review article: an analysis of safety profiles of treatments for diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018;48(8):817–830. doi: 10.1111/apt.14948
  • Chang L, Chey WD, Harris L, et al. Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. Am J Gastroenterol. 2006;101(5):1069–1079. doi: 10.1111/j.1572-0241.2006.00459.x
  • Tong K, Nicandro JP, Shringarpure R, et al. A 9-year evaluation of temporal trends in alosetron post-marketing safety under the risk management program. Therap Adv Gastroenterol. 2013;6(5):344–357. doi: 10.1177/1756283X13491798
  • Boinpally R, McGeeney D, Kaczynski E, et al. An open-label study to evaluate the effect of Eluxadoline on the single-dose pharmacokinetics of midazolam in healthy participants. Clin Pharmacol Drug Dev. 2022;11(11):1341–1348. doi: 10.1002/cpdd.1150
  • Khan Z, Khan SK, Reyaz I, et al. Effectiveness of Rifaximin on the outcomes of irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials. Cureus. 2023;15(9):e44807. doi: 10.7759/cureus.44807
  • Bruzzese E, Pesce M, Sarnelli G, et al. Pharmacokinetic drug evaluation of rifaximin for treatment of diarrhea-predominant irritable bowel syndrome. Expert Opin Drug Metab Toxicol. 2018;14(7):753–760. doi: 10.1080/17425255.2018.1488964
  • Kane JS, Ford AC. Rifaximin for the treatment of diarrhea-predominant irritable bowel syndrome. Expert Rev Gastroenterol Hepatol. 2016;10(4):431–442. doi: 10.1586/17474124.2016.1140571
  • Cash BD, Lembo K, Aggarwal K, et al. Mo1291 improvements in IBS-Related quality of life in a randomized, controlled repeat treatment trial (TARGET 3) of Rifaximin for IBS-D. Gastroenterology. 2015;148(4):S–663. doi: 10.1016/S0016-5085(15)32236-8
  • Cash BD, Pimentel M, Rao SSC, et al. Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial. Therap Adv Gastroenterol. 2017;10(9):689–699. doi: 10.1177/1756283X17726087
  • Colomier E, Algera J, Melchior C. Pharmacological therapies and their clinical targets in irritable bowel syndrome with diarrhea. Front Pharmacol. 2020;11:629026. doi: 10.3389/fphar.2020.629026
  • Lacy BE, Chang L, Rao SSC, et al. Rifaximin Treatment for Individual and multiple symptoms of irritable bowel syndrome with diarrhea: an analysis using new end points. Clin Ther. 2023;45(3):198–209. doi: 10.1016/j.clinthera.2023.01.010
  • Rifaximin FDA label [Internet]. 2023. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021361s031lbl.pdf
  • Schoenfeld P, Pimentel M, Chang L, et al. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials. Aliment Pharmacol Ther. 2014;39(10):1161–1168. doi: 10.1111/apt.12735
  • Ponziani FR, Pecere S, Lopetuso L, et al. Rifaximin for the treatment of irritable bowel syndrome - a drug safety evaluation. Expert Opin Drug Saf. 2016;15(7):983–991. doi: 10.1080/14740338.2016.1186639
  • Scarpellini E, Giorgio V, Gabrielli M, et al. Rifaximin treatment for small intestinal bacterial overgrowth in children with irritable bowel syndrome. Eur Rev Med Pharmacol Sci. 2013;17(10):1314–1320.
  • Collins BS, Lin HC. Double-blind, placebo-controlled antibiotic treatment study of small intestinal bacterial overgrowth in children with chronic abdominal pain. J Pediatr Gastroenterol Nutr. 2011;52(4):382–386. doi: 10.1097/MPG.0b013e3181effa3b
  • Pentikis HS, Connolly M, Trapnell CB, et al. The effect of multiple-dose, oral rifaximin on the pharmacokinetics of intravenous and oral midazolam in healthy volunteers. Pharmacotherapy. 2007;27(10):1361–1369. doi: 10.1592/phco.27.10.1361
  • Trapnell CB, Connolly M, Pentikis H, et al. Absence of effect of oral rifaximin on the pharmacokinetics of ethinyl estradiol/norgestimate in healthy females. Ann Pharmacother. 2007;41(2):222–228. doi: 10.1345/aph.1H395
  • Shaikh SD, Sun N, Canakis A, et al. Irritable bowel syndrome and the gut microbiome: a comprehensive review. J Clin Med. 2023;12(7):2558. doi: 10.3390/jcm12072558
  • Black CJ, Ford AC. Global burden of irritable bowel syndrome: trends, predictions and risk factors. Nat Rev Gastroenterol Hepatol. 2020;17(8):473–486. doi: 10.1038/s41575-020-0286-8
  • Farkouh A, Riedl T, Gottardi R, et al. Sex-related differences in pharmacokinetics and pharmacodynamics of frequently prescribed drugs: a review of the literature. Adv Ther. 2020;37(2):644–655. doi: 10.1007/s12325-019-01201-3
  • Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ. 2020;11(1):32. doi: 10.1186/s13293-020-00308-5
  • Ekhart C, van Hunsel F, Scholl J, et al. Sex differences in reported adverse drug reactions of selective serotonin reuptake inhibitors. Drug Saf. 2018;41(7):677–683. doi: 10.1007/s40264-018-0646-2
  • Miller MA. Gender-based differences in the toxicity of pharmaceuticals–the food and drug administration’s perspective. Int J Toxicol. 2001;20(3):149–152. doi: 10.1080/109158101317097728

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.