Slide #43. Functional Disorders - An Update 11/8/ MA ACP Annual Scientific Meeting. Functional Disorders: An Update

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1 Functional Disorders: An Update Anthony Lembo, M.D. Associate Professor of Medicine Beth Israel Deaconess Medical Center Harvard Medical School Boston, MA Disclosure of Financial Relationships Anthony Lembo, MD Has disclosed relationships with any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Consultantship Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, Astellas, GSK Honoraria Ironwood/Forest, Astra-Zeneca, Furiex, Salix, Prometheus, GSK Research Grants/Contracts Prometheus, Furiex Update on Chronic Constipation Prevalence range from 2 28% of the population 1.2% of the US population present to a physician complaining of constipation annually 2.7 million ambulatory visits and 555, ER visits Over $8 million dollars are spent on OTC laxatives each year More prescriptions written for laxatives than for antihypertensives or birth control Nearly 11 million in 1995 Martin BC, et al. Gastroenterology. 25;128:A-283. National Center of Health Statistics. 22. Passmore AP. Pharmacoeconomics. 1995;7:14.

2 Inpatient burden of CC in the US Sethi et al. Am J Gastroenterol 214 Functional Subtypes of Chronic Constipation Dyssynergic Defecation Outlet Obstruction Rectocele Descending perineum syndrome Rectal prolapse Evacuation Disorders 37% Slow- Transit Constipation 27% Irritable Bowel Syndrome/Normal Transit Constipation 58% Slow transit and IBS-C overlap in half of each group Schiller LR. Aliment Pharmacol Ther. 21;15: ; Videlock, Lembo, Cremonini NGM 213 Specialized Diagnosis Testing for Pelvic Floor Functioning Defecography and Colonic Transit Anorectal Manometry/ Balloon-explusion test Colonic Transit Testing Lembo A et al. N Engl J Med. 23; 349:136

3 Diagnosis Specialized Testing for Pelvic Floor Functioning and Colonic Transit in 214 MRI Defecography 3D High Resolution Manometry Wireless Motility Study Biofeedback therapy for normal transit constipation due to pelvic floor dyssynergia Patients randomized to receive 5 weekly biofeedback sessions or PEG g/day plus 5 weekly counseling sessions in preventing constipation ***p<.1 vs PEG Improvements in biofeedback group maintained at 12 and 24 months Biofeedback is effective in patients with pelvic floor dyssynergia Chiaroni et al, Gastroenterology 26; 13: Novel (and not so novel) Treatments for Functional Disorders

4 % with relief Treatment period Drug arm Therapeutic gain Placebo arm Natural history of disease + Placebo Effect Follow-up period *P< Week T1 A 6 p=.2 5 Global Improvement (IBS-GIS) Adequate 4 Relief 3 No Treatment Open Placebo B 12 p= SymptomSeverity Change (IBS-SSS) 6 IBS-QOL 4 2 No Treatment Open Placebo C D Percent with Adequate Relief (IBS-AR) No Treatment p=.3 Open Placebo Quality of Life Change (IBS-QOL) 15 p= No Treatment Open Placebo Well Not That Novel Dried Plums for Mild/Moderate Constipation: Dried plums (5 g b.d., fibre = 6 gm/day) psyllium (11 g b.d., fibre = 6 gm/day) 4 constipated subjects (m/f = 3/37, mean age = 38 years) Crossover trial with 3 weeks of treatment; 1-week washout period. Dried plums are safe, palatable and may be more effective than psyllium for the treatment of mild to moderate constipation Alimentary Pharmacology & Therapeutics Volume 33, Issue 7, pages , 15 FEB 211

5 Stimulant Laxative Bisacodyl for Constipation Functional Constipation (Rome III) Four weeks Bisacodyl 1 mg (n=247) Placebo (n=121) Dose titration down was allowed Adverse Events Diarrhea = 53% Abdominal pain = 25% AE leading to discontinuation = 18% Kamm et al. Clinical Gastro and Hep. 211; 9: Lubiprostone, a Cl C2 Channel Opener H 2 O Na + Cl Cl - - Enterocytes CFTR channel Ion Transport Cl C2 channel Tight junction H 2 O Na + K + Na + K + Na + 2Cl - K + T168 T14 Effects of Lubiprostone, Chloride Channel Activator, on Number of Spontaneous Bowel Movements 7 6 P =.1 P =.17 P =.2 P =.2 Mean SBMs per week µg lubiprostone bid Placebo n = 242 Baseline Week 1 Week 2 Week 3 Week 4 SBM = spontaneous bowel movements Johanson JF et al. Am J Gastroenterol. 28;13:17. T15

6 Lubiprostone for IBS-C: Combined Data from Two Phase 3 Trials Combined Overall Responders, % P =.1 12-wk treatment period Overall responder = monthly responder 2-3 mo Monthly responder = at least moderate relief 2-4 wk or significant relief >2-4 wk Drossman DA et al. Aliment Pharmacol Ther. 29;29: Linaclotide, Guanylate Cyclase-C Agonist Guanylate cyclase-c (GC-C) agonist Recommended dose: Constipation: 145 mcg QD IBS-C 29 mcg QD I Linaclotide Improves Weekly CSBMs 3 Treatment Period Randomized Withdrawal Weekly CSBMs 2 1 BL Study Week 29 ug Treatment Period 145 ug Placebo Randomized Withdrawal Sequence 29 ug 29 ug 145 ug 145 ug Placebo 29 ug 29 ug Placebo 145 ug Placebo Diarrhea: most common AE (14-16% linaclotide vs 5% placebo) Approximately 8% of Linaclotide vs. 4% of placebo treated patients withdrew from the study secondary to AEs Lembo, et al. NEJM, 211

7 Linaclotide in IBS-C Phase 3 Trial: Change in Abdominal Pain Over 26 Weeks Change in Abdominal Pain (%) Linaclotide 29 µg Placebo BL Trial Week Chey WD et al. American Journal of Gastroenterology 213 P=.7 for Week 1 P<.1 for Weeks 2-26 Polyethylene glycol Improves Constipation but Not Abdominal Pain in IBS-C? Chapman et al. Am J Gastroenterol 213; 18: Rifaximin for IBS with Diarrhea 2 identical phase 3, double-blind, placebo-controlled trials Randomized to rifaximin 55 mg or placebo, TID x 2 weeks 1. Pimintel M, Lembo A et al; TARGET Study Group. N Engl J Med. 211;364:22-32.

8 Low FODMAP VS Standard Diet IBS FODMAPs 1,2 Excess Fructose Honey, apples, pears, peaches, mangos, fruit juice, dried fruit Fructans Sorbitol Raffinose Wheat (large amounts), rye (large amounts), onions, leeks, zucchini Lentils, cabbage, brussels sprouts, asparagus, green beans, legumes % Patients Improved FODMAPs = Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols. 1. Shepherd SJ, et al. Clin Gastroenterol Hepatol. 28;6: Shepherd SJ, Gibson PR. J Am Diet Assoc. 26;16: FODMAP n=43 (after 6/9). Standard diet n=39 (before 6/9). Consecutive IBS patients (NICE) from London. Staudacher HM, et al. J Hum Nutr Diet. 211 A Low FODMAP Diet Reduces IBS Symptoms A randomized, controlled, single-blind, cross-over trial of patients with IBS Halmos, et al. Gastroenterology, 214,146,1, Gluten Free Diet for Functional Disorders? Similar & significant differences for: Abdominal pain, bloating, tiredness & satisfaction with stool consistency

9 A Controlled Trial of Gluten-Free Diet in IBS-D Vazquez-Roque, Camilleri, et al. Gastroenterology 213 Volume 144, Issue 5 Acotiamide, 1st Approved Treatment for Functional Dyspepsia: Available in Japan Enhances acetylcholine release by inhibiting cholinesterase activity and may also have CNS effects as well. overall treatment efficacy Matsueda et al. Gut 211 Opioid-Induced Constipation Affects 4-5% of patients Does not improve with continued opioid exposure Currently FDA Approved Therapies Lubiprostone PAMORAs Methylnaltrexone Advanced illness insufficient response to laxatives Chronic noncancer pain Naloxegol Chronic noncancer pain Binding of opioids to central mu-opioid receptors analgesic effect Binding of opioids to mu-opioid receptors in GI tract constipation Coyne KS, et al. Clinicoecon Outcomes Res. 214;6: Bell TJ, et al. Pain Med. 29;1: Chey WD, et al. N Engl J Med. 214;37:

10 Conclusions The field of Functional GI Disorders is rapidly evolving. Our understanding of the pathophysiology continues to increase and treatment options have improved with promise for even better therapies in the future

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