Analysis of the impact on efficacy of lubiprostone dose reduction to manage adverse events in the treatment of chronic constipation in Japan

References

• Black CJ, Ford AC. Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management. Med J Aust. 2018;209(2):86–91.
   PubMed Web of Science ®Google Scholar
• Cash BD, Acosta RD, Chandrasekhara V, et al. The role of endoscopy in the management of constipation. Gastrointest Endosc. 2014;80(4):563–565.
   PubMed Web of Science ®Google Scholar
• Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(9):1582–1591. quiz1581, 1592.
   PubMed Web of Science ®Google Scholar
• Tamura A, Tomita T, Oshima T, et al. Prevalence and self-recognition of chronic constipation: results of an internet survey. J Neurogastroenterol Motil. 2016;22(4):677–685.
   PubMed Web of Science ®Google Scholar
• Choung RS, Locke GRs3rd, Schleck CD, et al. Cumulative incidence of chronic constipation: a population-based study 1988-2003. Aliment Pharmacol Ther. 2007;26(11–12):1521–1528.
   PubMed Web of Science ®Google Scholar
• Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007;25(5):599–608.
   PubMed Web of Science ®Google Scholar
• Hayat M, Zia H, Nusrat S. Lubiprostone in the treatment of chronic idiopathic constipation: an update on health-related quality of life and patient-reported outcomes. Patient Relat Outcome Meas. 2019;10:43–47.
   PubMed Web of Science ®Google Scholar
• Herrick LM, Spalding WM, Saito YA, et al. A case-control comparison of direct healthcare-provider medical costs of chronic idiopathic constipation and irritable bowel syndrome with constipation in a community-based cohort. J Med Econ. 2017;20(3):273–279.
   PubMed Web of Science ®Google Scholar
• Camilleri M, Bharucha AE. Behavioural and new pharmacological treatments for constipation: getting the balance right. Gut. 2010;59(9):1288–1296.
   PubMed Web of Science ®Google Scholar
• Wilson N, Schey R. Lubiprostone in constipation: clinical evidence and place in therapy. Ther Adv Chronic Dis. 2015;6(2):40–50.
   PubMed Web of Science ®Google Scholar
• Liu LW. Chronic constipation: current treatment options. Can J Gastroenterol. 2011;25(suppl b):22b–28b.
   PubMedGoogle Scholar
• Bharucha AE, Lacy BE. Mechanisms, evaluation, and management of chronic constipation. Gastroenterology. 2020;158(5):1232–1249.e1233.
   PubMed Web of Science ®Google Scholar
• Lacy BE, Levy LC. Lubiprostone: a novel treatment for chronic constipation. Clin Interv Aging. 2008;3(2):357–364.
   PubMed Web of Science ®Google Scholar
• Camilleri M, Bharucha AE, Ueno R, et al. Effect of a selective chloride channel activator, lubiprostone, on gastrointestinal transit, gastric sensory, and motor functions in healthy volunteers. Am J Physiol Gastrointest Liver Physiol. 2006;290(5):G942–947.
   PubMed Web of Science ®Google Scholar
• Johanson JF, Ueno R. Lubiprostone, a locally acting chloride channel activator, in adult patients with chronic constipation: a double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety. Aliment Pharmacol Ther. 2007;25(11):1351–1361.
   PubMed Web of Science ®Google Scholar
• Johanson JF, Morton D, Geenen J, et al. 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally-acting type-2 chloride channel activator, in patients with chronic constipation. Am J Gastroenterol. 2008;103(1):170–177.
   PubMed Web of Science ®Google Scholar
• Fukudo S, Hongo M, Kaneko H, et al. Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study. Neurogastroenterol Motil. 2011;23(6):544–e205.
   PubMed Web of Science ®Google Scholar
• Lembo AJ, Johanson JF, Parkman HP, et al. Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation. Dig Dis Sci. 2011;56(9):2639–2645.
   PubMed Web of Science ®Google Scholar
• Fukudo S, Hongo M, Kaneko H, et al. Lubiprostone increases spontaneous bowel movement frequency and quality of life in patients with chronic idiopathic constipation. Clin Gastroenterol Hepatol. 2015;13(2):294–301.e295.
   PubMed Web of Science ®Google Scholar
• Cryer B, Drossman DA, Chey WD, et al. Analysis of nausea in clinical studies of lubiprostone for the treatment of constipation disorders. Dig Dis Sci. 2017;62(12):3568–3578.
   PubMed Web of Science ®Google Scholar
• Shah ED, Suresh S, Jou J, et al. Evaluating when and why patients discontinue chronic therapy for irritable bowel syndrome with constipation and chronic idiopathic constipation. Am J Gastroenterol. 2020;115(4):596–602.
   PubMed Web of Science ®Google Scholar
• Ohbayashi H, Sato Y, Kiuchi M, et al. Open-label study to evaluate the treatment continuation rate after a dose reduction of lubiprostone due to onset of adverse events. Expert Rev Gastroenterol Hepatol. 2021;15(3):333–342.
   PubMed Web of Science ®Google Scholar
• Miwa H, Torii A, Maeda K, Akiho H, Araki Y, Iijima H. Evidence-based clinical practice guidelines for chronic constipation 2017. [in Japanese]. Tokyo: Nankodo Press;2017. Vol. 2017. p. 66–68.
   Google Scholar
• Drossman DA, Hasler WL. Rome IV– functional GI disorders: disorders of gut-brain interaction. Gastroenterology. 2016;150(6):1257–1261.
   PubMed Web of Science ®Google Scholar
• Leporini C, De Sarro G, Russo E. Adherence to therapy and adverse drug reactions: is there a link? Expert Opin Drug Saf. 2014;13 Suppl 1(sup1):S41–55.
   PubMedGoogle Scholar
• Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32(9):920–924.
   PubMed Web of Science ®Google Scholar
• Chang L, Chey WD, Drossman D, et al. Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2016;44(10):1114–1122.
   PubMed Web of Science ®Google Scholar
• Chamberlain SM, Rao SS. Safety evaluation of lubiprostone in the treatment of constipation and irritable bowel syndrome. Expert Opin Drug Saf. 2012;11(5):841–850.
   PubMed Web of Science ®Google Scholar