99
Views
21
CrossRef citations to date
0
Altmetric
Drug Profile

Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective

Pages 13-29 | Published online: 10 Jan 2014

References

  • Mertz HR. Irritable bowel syndrome. N. Engl. J. Med.349(22), 2136–2146 (2003).
  • Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology130(5), 1480–1491 (2006).
  • Drossman DA. Review article: an integrated approach to the irritable bowel syndrome. Aliment. Pharmacol. Ther.13(Suppl. 2), 3–14 (1999).
  • American College of Gastroenterology Task Force on Irritable Bowel Syndrome. An evidence-based position statement on the management of irritable bowel syndrome. Am. J. Gastroenterol.104(Suppl. 1), S1–S35 (2009).
  • Mayer EA. Clinical practice. Irritable bowel syndrome. N. Engl. J. Med.358(16), 1692–1699 (2008).
  • Saito YA, Schoenfeld P, Locke GR 3rd. The epidemiology of irritable bowel syndrome in North America: a systematic review. Am. J. Gastroenterol.97(8), 1910–1915 (2002).
  • Systematic review on the management of irritable bowel syndrome in the European Union. Eur. J. Gastroenterol. Hepatol.19(Suppl. 1), S11–S37 (2007).
  • Andrews EB, Eaton SC, Hollis KA et al. Prevalence and demographics of irritable bowel syndrome: results from a large web-based survey. Aliment. Pharmacol. Ther.22(10), 935–942 (2005).
  • Drossman DA, Li Z, Andruzzi E et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig. Dis. Sci.38(9), 1569–1580 (1993).
  • Hungin AP, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Aliment. Pharmacol. Ther.21(11), 1365–1375 (2005).
  • Drossman DA, Morris CB, Hu Y et al. A prospective assessment of bowel habit in irritable bowel syndrome in women: defining an alternator. Gastroenterology128(3), 580–589 (2005).
  • Ersryd A, Posserud I, Abrahamsson H, Simren M. Subtyping the irritable bowel syndrome by predominant bowel habit: Rome II versus Rome III. Aliment. Pharmacol. Ther.26(6), 953–961 (2007).
  • El-Serag HB, Olden K, Bjorkman D. Health-related quality of life among persons with irritable bowel syndrome: a systematic review. Aliment. Pharmacol. Ther.16(6), 1171–1185 (2002).
  • Drossman DA, Chang L, Schneck S, Blackman C, Norton WF, Norton NJ. A focus group assessment of patient perspectives on irritable bowel syndrome and illness severity. Dig. Dis. Sci.54(7), 1532–1541 (2009).
  • Lembo A, Ameen VZ, Drossman DA. Irritable bowel syndrome: toward an understanding of severity. Clin. Gastroenterol. Hepatol.3(8), 717–725 (2005).
  • Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology119(3), 654–660 (2000).
  • Longstreth GF, Yao JF. Irritable bowel syndrome and surgery: a multivariable analysis. Gastroenterology126(7), 1665–1673 (2004).
  • American Gastroenterological Association. American Gastroenterological Association medical position statement: irritable bowel syndrome. Gastroenterology123(6), 2105–2107 (2002).
  • Posserud I, Ersryd A, Simren M. Functional findings in irritable bowel syndrome. World J. Gastroenterol.12(18), 2830–2838 (2006).
  • Choung RS, Locke GR 3rd, Zinsmeister AR, Schleck CD, Talley NJ. Psychosocial distress and somatic symptoms in community subjects with irritable bowel syndrome: a psychological component is the rule. Am. J. Gastroenterol.104(7), 1772–1779 (2009).
  • Camilleri M, Choi MG. Review article: irritable bowel syndrome. Aliment. Pharmacol. Ther.11(1), 3–15 (1997).
  • Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology123(6), 2108–2131 (2002).
  • Tornblom H, Abrahamsson H, Barbara G et al. Inflammation as a cause of functional bowel disorders. Scand. J. Gastroenterol.40(10), 1140–1148 (2005).
  • Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology136(6), 1979–1988 (2009).
  • Dunlop SP, Jenkins D, Neal KR, Spiller RC. Relative importance of enterochromaffin cell hyperplasia, anxiety, and depression in postinfectious IBS. Gastroenterology125(6), 1651–1659 (2003).
  • Bercik P, Verdu EF, Collins SM. Is irritable bowel syndrome a low-grade inflammatory bowel disease? Gastroenterol. Clin. North Am.34(2), 235–245, vi–vii (2005).
  • Sidhu R, Drew K, McAlindon ME, Lobo AJ, Sanders DS. Elevated serum chromogranin A in irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD): a shared model for pathogenesis? Inflamm. Bowel Dis. DOI: 10.1002/ibd.20982 (2009) (Epub ahead of print).
  • Santos J, Alonso C, Vicario M, Ramos L, Lobo B, Malagelada JR. Neuropharmacology of stress-induced mucosal inflammation: implications for inflammatory bowel disease and irritable bowel syndrome. Curr. Mol. Med.8(4), 258–273 (2008).
  • Grover M, Herfarth H, Drossman DA. The functional-organic dichotomy: postinfectious irritable bowel syndrome and inflammatory bowel disease-irritable bowel syndrome. Clin. Gastroenterol. Hepatol.7(1), 48–53 (2009).
  • Gershon MD. Review article: roles played by 5-hydroxytryptamine in the physiology of the bowel. Aliment. Pharmacol. Ther.13(Suppl. 2), 15–30 (1999).
  • De Ponti F, Tonini M. Irritable bowel syndrome: new agents targeting serotonin receptor subtypes. Drugs61(3), 317–332 (2001).
  • Gershon MD. Serotonin and its implication for the management of irritable bowel syndrome. Rev. Gastroenterol. Disord.3(Suppl. 2), S25–S34 (2003).
  • Bulbring E, Crema A. The release of 5-hydroxytryptamine in relation to pressure exerted on the intestinal mucosa. J. Physiol.146(1), 18–28 (1959).
  • Minami M, Tamakai H, Ogawa T et al. Chemical modulation of 5-HT3 and 5-HT4 receptors affects the release of 5-hydroxytryptamine from the ferret and rat intestine. Res. Commun. Mol. Pathol. Pharmacol.89(2), 131–142 (1995).
  • Delvaux M, Louvel D, Mamet JP, Campos-Oriola R, Frexinos J. Effect of alosetron on responses to colonic distension in patients with irritable bowel syndrome. Aliment. Pharmacol. Ther.12(9), 849–855 (1998).
  • Bardhan KD, Bodemar G, Geldof H et al. A double-blind, randomized, placebo-controlled dose-ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome. Aliment. Pharmacol. Ther.14(1), 23–34 (2000).
  • Houghton LA, Foster JM, Whorwell PJ. Alosetron, a 5-HT3 receptor antagonist, delays colonic transit in patients with irritable bowel syndrome and healthy volunteers. Aliment. Pharmacol. Ther.14(6), 775–782 (2000).
  • Miller JL. Alosetron approved for treatment of irritable bowel syndrome. Am. J. Health Syst. Pharm.57(6), 519 (2000).
  • Olden K, DeGarmo RG, Jhingran P et al. Patient satisfaction with alosetron for the treatment of women with diarrhea-predominant irritable bowel syndrome. Am. J. Gastroenterol.97(12), 3139–3146 (2002).
  • Chang L, Chey WD, Harris L, Olden K, Surawicz C, Schoenfeld P. 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.101(5), 1069–1079 (2006).
  • Horton R. Lotronex and the FDA: a fatal erosion of integrity. Lancet357(9268), 1544–1545 (2001).
  • McCarthy M. FDA recommends bringing controversial IBS drug back. Lancet359(9316), 1491–1492 (2002).
  • Andresen V, Hollerbach S. Reassessing the benefits and risks of alosetron: what is its place in the treatment of irritable bowel syndrome? Drug Saf.27(5), 283–292 (2004).
  • Ameen VZ, Tong K, Pan H. The Risk Management Program (RiskMAP) is effective in mitigating serious outcomes of ischemic colitis and complications of constipation with marketed use of alosetron since reintroduction. Presented at: 2008 Annual Meeting of the American College of Gastroenterology. Orlando, FL, USA, 3–8 October 2008 (Abstract P693).
  • Prometheus Laboratories. Lotronex® (alosetron hydrochloride) tablets (package insert). Prometheus Laboratories Inc., San Diego, CA, USA (2008).
  • Karwoski CB. Practical experience with risk management plans in the US. Presented at: 42nd Annual Drug Information Association Meeting. Philadelphia, PA, USA, 18–22 June (2006).
  • Koch KM, Corrigan BW, Manzo J et al. Alosetron repeat dose pharmacokinetics, effects on enzyme activities, and influence of demographic factors. Aliment. Pharmacol. Ther.20(2), 223–230 (2004).
  • Koch K, Campanella C, Baidoo CA, Manzo JA, Ameen VZ, Kersey KE. Pharmacodynamics and pharmacokinetics of oral contraceptives co-administered with alosetron (Lotronex). Dig. Dis. Sci.49(7–8), 1244–1249 (2004).
  • Koch KM, Ricci BM, Hedayetullah NS, Jewell D, Kersey KE. Effect of alosetron on theophylline pharmacokinetics. Br. J. Clin. Pharmacol.52(5), 596–600 (2001).
  • D’Souza DL, Dimmitt DC, Robbins DK, Nezamis J, Simms L, Koch KM. Effect of alosetron on the pharmacokinetics of fluoxetine. J. Clin. Pharmacol.41(4), 455–458 (2001).
  • D’Souza DL, Levasseur LM, Nezamis J, Robbins DK, Simms L, Koch KM. Effect of alosetron on the pharmacokinetics of alprazolam. J. Clin. Pharmacol.41(4), 452–454 (2001).
  • Gunput MD. Review article: clinical pharmacology of alosetron. Aliment. Pharmacol. Ther.13(Suppl. 2), 70–76 (1999).
  • Bearcroft CP, Andre EA, Farthing MJ. In vivo effects of the 5-HT3 antagonist alosetron on basal and cholera toxin-induced secretion in the human jejunum: a segmental perfusion study. Aliment. Pharmacol. Ther.11(6), 1109–1114 (1997).
  • Pasricha PJ. Desperately seeking serotonin. A commentary on the withdrawal of tegaserod and the state of drug development for functional and motility disorders. Gastroenterology132(7), 2287–2290 (2007).
  • Hasler WL, Schoenfeld P. Safety profile of tegaserod, a 5-HT4 receptor agonist, for the treatment of irritable bowel syndrome. Drug Saf.27(9), 619–631 (2004).
  • Ford AC, Brandt LJ, Young C, Chey WD, Foxx-Orenstein AE, Moayyedi P. Efficacy of 5-HT3 antagonists and 5-HT4 agonists in irritable bowel syndrome: systematic review and meta-analysis. Am. J. Gastroenterol.104(7), 1831–1843 (2009).
  • Glaxo Wellcome withdraws irritable bowel syndrome medication. FDA Consum.35(1), 3 (2001).
  • Krause R, Ameen V, Gordon SH 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.102(8), 1709–1719 (2007).
  • Lembo AJ, Olden KW, Ameen VZ, Gordon SL, Heath AT, Carter EG. Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials. Clin. Gastroenterol. Hepatol.2(8), 675–682 (2004).
  • Lembo T, Wright RA, Bagby B et al. Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. Am. J. Gastroenterol.96(9), 2662–2670 (2001).
  • Chey WD, Chey WY, Heath AT et al. Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. Am. J. Gastroenterol.99(11), 2195–2203 (2004).
  • Camilleri M, Northcutt AR, Kong S, Dukes GE, McSorley D, Mangel AW. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. Lancet355(9209), 1035–1040 (2000).
  • Camilleri M, Chey WY, Mayer EA et al. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch. Intern. Med.161(14), 1733–1740 (2001).
  • Camilleri M, Mayer EA, Drossman DA et al. Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist. Aliment. Pharmacol. Ther.13(9), 1149–1159 (1999).
  • Hahn BA, Kirchdoerfer LJ, Fullerton S, Mayer E. Evaluation of a new quality of life questionnaire for patients with irritable bowel syndrome. Aliment. Pharmacol. Ther.11(3), 547–552 (1997).
  • Watson ME, Lacey L, Kong S et al. Alosetron improves quality of life in women with diarrhea-predominant irritable bowel syndrome. Am. J. Gastroenterol.96(2), 455–459 (2001).
  • Wolfe SG, Chey WY, Washington MK et al. Tolerability and safety of alosetron during long-term administration in female and male irritable bowel syndrome patients. Am. J. Gastroenterol.96(3), 803–811 (2001).
  • Lembo A, Weber HC, Farraye FA. Alosetron in irritable bowel syndrome: strategies for its use in a common gastrointestinal disorder. Drugs63(18), 1895–1905 (2003).
  • Gallo-Torres H, Brinker A, Avigan M. Alosetron: ischemic colitis and serious complications of constipation. Am. J. Gastroenterol.101(5), 1080–1083 (2006).
  • American Gastroenterological Association Medical Position Statement: guidelines on intestinal ischemia. Gastroenterology118(5), 951–953 (2000).
  • Greenwald DA, Brandt LJ. Colonic ischemia. J. Clin. Gastroenterol.27(2), 122–128 (1998).
  • Ringel Y, Wilson J, D’Agostino R, Henson L, Lewis J. Development and validation of an ischemic colitis clinical diagnostic assessment instrument. Gastroenterology128(4 Suppl. 2), A467 (2005) (Abstract 1152).
  • Camilleri M. Is there an experimental basis for the development of ischaemic colitis as a result of 5-HT3 antagonist treatment? Neurogastroenterol. Motil.19(2), 77–84 (2007).
  • Grundy D, McLean P, Stead R. Impact of 5-HT3 receptor blockade on colonic haemodynamic responses to ischaemia and reperfusion in the rat. Neurogastroenterol. Motil.19(7), 607–616 (2007).
  • Friedel D, Thomas R, Fisher RS. Ischemic colitis during treatment with alosetron. Gastroenterology120(2), 557–560 (2001).
  • Hervé S, Beaugerie L, Bouhnik Y et al. Irritable bowel syndrome is more frequent in patients hospitalized for ischaemic colitis: results of a case–control study. Neurogastroenterol. Motil.21(11), 1170–e102 (2009).
  • Cole JA, Cook SF, Sands BE, Ajene AN, Miller DP, Walker AM. Occurrence of colon ischemia in relation to irritable bowel syndrome. Am. J. Gastroenterol.99(3), 486–491 (2004).
  • Walker AM, Bohn RL, Cali C, Cook SF, Ajene AN, Sands BE. Risk factors for colon ischemia. Am. J. Gastroenterol.99(7), 1333–1337 (2004).
  • Chang L, Kahler KH, Sarawate C, Quimbo R, Kralstein J. Assessment of potential risk factors associated with ischaemic colitis. Neurogastroenterol. Motil.20(1), 36–42 (2008).
  • Suh DC, Kahler KH, Choi IS, Shin H, Kralstein J, Shetzline M. Patients with irritable bowel syndrome or constipation have an increased risk for ischaemic colitis. Aliment. Pharmacol. Ther.25(6), 681–692 (2007).
  • Miller DP, Alfredson T, Cook SF, Sands BE, Walker AM. Incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery in relation to use of alosetron hydrochloride. Am. J. Gastroenterol.98(5), 1117–1122 (2003).
  • Camilleri M, Mayer EA. Developing irritable bowel syndrome guidelines through meta-analyses: does the emperor really have new clothes? Gastroenterology137(3), 766–769 (2009).
  • Miller D, Bennett L, Hollis K, Tennis P, Cook S, Andrews E. A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme. Aliment. Pharmacol. Ther.24(5), 869–878 (2006).
  • Traynor K. Alosetron use drops dramatically with risk management. Am. J. Health Syst. Pharm.61(12), 1210–1212 (2004).
  • Tuncer C, Cindoruk M, Dursun A, Karakan T. Prevalence of microscopic colitis in patients with symptoms suggesting irritable bowel syndrome. Acta Gastroenterol. Belg.66(2), 133–136 (2003).
  • Murray JA, Van Dyke C, Plevak MF, Dierkhising RA, Zinsmeister AR, Melton LJ 3rd. Trends in the identification and clinical features of celiac disease in a North American community, 1950–2001. Clin. Gastroenterol. Hepatol.1(1), 19–27 (2003).
  • Kalliomaki MA. Food allergy and irritable bowel syndrome. Curr. Opin. Gastroenterol.21(6), 708–711 (2005).
  • Lacy BE. Evolving concepts in irritable bowel syndrome. Suppl. Gastroenterol. Endosc. News6, 51–64 (2008).
  • Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological treatments for irritable bowel syndrome: a systematic review and meta-analysis. J. Consult. Clin. Psychol.72(6), 1100–1113 (2004).
  • Schiller LR, Johnson DA. Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care. Am. J. Gastroenterol.103(4), 815–819 (2008).
  • Graham DJ, Drinkard CR, Shatin D. Incidence of idiopathic acute liver failure and hospitalized liver injury in patients treated with troglitazone. Am. J. Gastroenterol.98(1), 175–179 (2003).
  • Fontana RJ, McCashland TM, Benner KG et al. Acute liver failure associated with prolonged use of bromfenac leading to liver transplantation. The Acute Liver Failure Study Group. Liver Transpl. Surg.5(6), 480–484 (1999).
  • Lazarczyk DA, Goldstein NS, Gordon SC. Trovafloxacin hepatotoxicity. Dig. Dis. Sci.46(4), 925–926 (2001).
  • Feld AD. Legal risks in treating irritable bowel syndrome. Rev. Gastroenterol. Disord.3(Suppl. 3), S25–S31 (2003).
  • Charapata C, Mertz H. Physician knowledge of Rome symptom criteria for irritable bowel syndrome is poor among non-gastroenterologists. Neurogastroenterol. Motil.18(3), 211–216 (2006).
  • Lacy BE, Rosemore J, Robertson D, Corbin DA, Grau M, Crowell MD. Physicians’ attitudes and practices in the evaluation and treatment of irritable bowel syndrome. Scand. J. Gastroenterol.41(8), 892–902 (2006).
  • Adeniji OA, Barnett CB, Di Palma JA. Durability of the diagnosis of irritable bowel syndrome based on clinical criteria. Dig. Dis. Sci.49(4), 572–574 (2004).
  • Spiegel BM, DeRosa VP, Gralnek IM, Wang V, Dulai GS. Testing for celiac sprue in irritable bowel syndrome with predominant diarrhea: a cost–effectiveness analysis. Gastroenterology126(7), 1721–1732 (2004).
  • Williams RE, Black CL, Kim HY et al. Stability of irritable bowel syndrome using a Rome II-based classification. Aliment. Pharmacol. Ther.23(1), 197–205 (2006).
  • Halder SL, Locke GR 3rd, Schleck CD, Zinsmeister AR, Melton LJ 3rd, Talley NJ. Natural history of functional gastrointestinal disorders: a 12-year longitudinal population-based study. Gastroenterology133(3), 799–807 (2007).
  • Lacy BE, Weiser K, Noddin L et al. Irritable bowel syndrome: patients’ attitudes, concerns and level of knowledge. Aliment. Pharmacol. Ther.25(11), 1329–1341 (2007).
  • Mangel AW. Personal view: adequate relief as a primary endpoint in irritable bowel syndrome. Aliment. Pharmacol. Ther.23(7), 879–881 (2006).
  • Kaptchuk TJ, Kelley JM, Conboy LA et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ336(7651), 999–1003 (2008).
  • Lembo AJ, Neri B, Tolley J, Barken D, Carroll S, Pan H. Use of serum biomarkers in a diagnostic test for irritable bowel syndrome. Aliment. Pharmacol. Ther.29(8), 834–842 (2009).

Websites

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.