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Aetiopathogenesis of Functional Dyspepsia

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Aetiopathogenesis of Functional Dyspepsia NZ 2019 Aetiopathogenesis of functional dyspepsia Genetic DUODENAL LUMEN predisposition GUT EPITHELIUM BRAIN ↑ Epithelial permeability Pathogens or allergens Anxiety or stress response APC Eotaxin release LAMINA PROPRIA Eosinophil activation Disordered motility and visceral hypersensitivity Immune cells Th2-cell Interleukin-4 response Interleukin-13 Interleukin-5 Early satiety Eosinophil degranulation B-cell response ↑ Inflammatory cytokines TNFα, Eosinophil interleukin-10, and Epigastric recruitment interleukin-1β Release of Nerve proallergic IgE pain, infringement DUODENUM Delayed gastric emptying burning Nerve firing Muscle contractions Fullness post and pain Talley & Ford.MUSCL NE FIBER EnglS J Med 2015:373:1853-63 meal Nicholas J. Talley AC, MD, PhD University of Newcastle, Australia Disclosures Grant / Research Support Committees Commonwealth Diagnostics (International) (IBS) Australian Medical Council (AMC) Council Member (ceased 2017) MBS Review Taskforce NHMRC Principal Committee, Research Committee HVN National Science Challenge NZ (no financial Asia Pacific Association of Medical Journal Editors (APAME) support) Patents Consultancies Biomarkers of irritable bowel syndrome (#12735358.9 - Takeda (gastroparesis) 1405/2710383 and (#12735358.9 -1405/2710384) Adelphi values (functional dyspepsia working group to develop a symptom based PRO instrument) Licensing Questionnaires (Mayo Clinic) Talley Bowel Disease Questionnaire, Mayo Dysphagia Questionnaire Allergens PLC GI therapies (non-invasive device company, consultant and Nestec European Patent Application No. 12735358.9 options) Singapore ‘Provisional’ Patent NTU Ref: TD/129/17 IM Health Sciences, USA “Microbiota Modulation of BDNF Tissue Repair Napo Pharmaceutical Pathway” Outpost Medicine Editorial Samsung Bioepis Synergy Medical Journal of Australia (Editor-in-Chief) Theravance Up to Date (Section Editor) Avant Foundation (judging of research grants) Precision and Future Medicine, Sungkyunkwan University School of Medicine, South Korea Community and patient advocacy groups Boards GESA Board Member. Gastroenterology Society of Advisory Board, IFFGD (International Foundation for Functional Australia GI Disorders) Rome IV Functional Dyspepsia Epigastric pain Postprandial distress syndrome (EPS) syndrome (PDS) Early Postprandial Epigastric Epigastric satiation, heaviness or pain burning may lose fullness weight Bothersome, at least 1 day a week Bothersome, at least 3 days a week D3 Epidemiology by endoscopy Of 1000 Swedish subjects: • 202 (20%) uninvestigated dyspepsia • 157 (16%) functional dyspepsia (FD) • 52 epigastric pain syndrome (EPS): 33% of FD • 122 postprandial distress syndrome (PDS): 78% • 17 EPS and PDS overlap: 11% Functional dyspepsia common, postprandial distress most prevalent subtype Aro, Talley et al. Gastroenterology. 2009;137:94-100 Epidemiology of FD Italy Scandinavia USA Loiano & Monghidoro study Kalixanda study Olmsted County No FD No FD No FD FD FD FD EPS alone Overlapping EPS EPS alone EPS alone Overlapping EPS and PDS and PDS Overlapping EPS and PDS PDS alone PDS alone PDS alone Tack J & Talley NJ, Nat Rev Gastroenterol Hepatol 2013; 10:134 10-year FD follow-up FD IBS post upper GERD endoscopy: Change of FD, reflux (GERD), and IBS from GERD base-line to follow-up FD leads to symptomatic GERD or IBS IBS (same spectrum) Aro P, Talley NJ, et al. Gastroenterology 2015;148:928-37 Functional dyspepsia may be increasing • Östhammar community, Sweden • All inhabitants above 18 years born day 3, 12, 24 every month • 4 repeated validated ASQ postal surveys • 1988, 1989, 1995 and 2011 → 23 year follow up • Total 1884 participants participated on 4509 occasions • On average 2.4 occasions each • 444 participated in all 4 surveys Effect of time (mixed effects logistic regression adjusting age, sex): FD OR=2.24 (1.71-2.94) PDS OR=3.51 (2.57-4.81) EPS OR=1.5 (1.09-2.05) Andreason, Talley et al. Odds of dyspepsia doubled - corresponding to an absolute increase in prevalence of 8 % (10 % PDS and 3 % EPS) Traditional pathophysiology of functional dyspepsia Gastric acid Gastric acid NOT increased Gastritis NOT associated H. pylori with symptoms Impaired fundic Functional dyspepsia with accommodation early satiety Delayed gastric Correlates very poorly with emptying symptoms Hypersensitivity Functional dyspepsia with to distention pain Talley and Ford. N Engl J Med 2015373:1853-63 Empirical evidence: what works? Functional dyspepsia patient H. pylori positive H. pylori negative H. pylori PPI Eradication No response No response Response Response TCA Response Success No response Response Prokinetic Response No response Consider psychotherapy ACG Guideline Moayyedi PM, Lacy BE et al. Am J Gastroenterol 2017;112:998-1013 Forest plot of randomized controlled trials comparing PPIs with placebo in FD • 15 RCTs, 5853 FD patients • RR = 0.87 (95% CI 0.82 -0.94) • NNT = 10 (95% CI 7- 20) Moayyedi et al. Am J Gastroenterol 2017;112:998-1013 Is there a subgroup that responds better to PPI? Rome III definitions: Postprandial distress not EPS – WHY? Pinto-Sanchez MI et al. Cochrane Library 2017 H. pylori and gastritis: a Nobel story Functional dyspepsia: • Rome IV • Kyoto consensus Gut. 2015;64(9):1353-67 H. pylori and functional dyspepsia Figure 10. Forest plot of randomized controlled trials comparing H. pylori eradication with placebo antibiotics in H. pylori-infected patients with functional dyspepsia. EPS may be most responsive NNT = 17 Moayyedi et al. Am J Gastroenterol 2017;112:998-1013 H. pylori gastritis is NOT associated with dyspepsia symptoms – so why does eradication therapy work? • Longitudinal population-based study Osthammar, Sweden • A randomly sampled adult population completed a validated GI symptom questionnaire in 2011 (N = 1175) • Participants <80 years of age and who were eligible were invited to undergo upper endoscopy (OGD) (N = 947); 402 accepted and 368 successfully underwent OGD with antral and body biopsies. H. pylori serology was also performed • Participants: 368 community individuals (average 54.1 years, range 20-79 years; 47.8% male) • Main outcome measures: Prevalence of histological gastritis and its subtypes, association between symptoms and findings on endoscopy Results: Gastritis was found in 40.2%. • Gastritis and gastritis subtypes were not associated with GI symptoms versus those with a normal gastric biopsy • Postprandial distress syndrome (PDS) negatively associated with gastritis, specifically H. pylori gastritis – WHY? UEGW 2019. Zuzek, Walker, Talley et al. Gastritis in a Community Population – Prevalence of Histological Types and Association with Symptoms Prokinetics, fundic relaxors and visceral analgesics Examples of localization and nature of target receptors Camilleri et al. Gastroenterology 2016;150:1319-31. Functional Dyspepsia: fundic relaxation as a target Normal fundic Meal accommodation or receptive relaxation Relax the fundus: Impaired fundic accommodation ➢ Serotonin 5HT4 agonists: cisapride with a redistribution of food to antrum 40% ➢ Serotonin 1 agonists: sumatriptan (5HT1p), buspirone (5HT1a) ➢ Acotiamide ➢ STW 5 (Iberogast) Tack et al. Gastroenterology 1998; 115:1346-52 Acotiamide in functional dyspepsia Japanese phase 3 study ➢ Enhances acetylcholine release via • FD 100 mg acotiamide or placebo TID 4 M1/M2 antagonism wks ➢ Inhibits acetylcholinesterase activity • Elimination rate all 3 meal-related ➢ Accelerates gastric emptying and symptoms 15% acotiamide vs. 9% placebo (p=0.004): NNT 16 enhances gastric accommodation Matsueda et al., Gut 2012 Forest plot of randomized controlled trials comparing motility modifying drugs with placebo in functional dyspepsia patients Moayyedi, PM et al. AJG 2017 ✓ Cisapride ✓ Tegaserod ✓ Acotiamide ? Others Functional dyspepsia treatment trial (NIH): Antidepressants Talley NJ et al. Gastroenterology. 2015;149(2):340-9 Other antidepressants in FD Mirtazepine 15 mg daily n=29 F with weight Venlafaxine XR: 8 wks (2 wks 75 mg once loss: tetracyclic antidepressant, anti-emetic, daily, 4 wks 150 mg once daily, and 2 wks 75 mg once daily) appetite stimulant Early satiety Diaries 70 60 50 40 Mirtazapine Placebo 30 20 Mean severity score (VAS) score severity Mean 10 0 Week - Week Week Week Week Week Week Week Week 1 1 2 3 4 5 6 7 8 Clin Gastroenterol Hepatol. 2016;14:385-392 Clin Gastroenterol Hepatol. 2008;6:746-52 Buspirone (5HT 1A agonist) in functional dyspepsia Tack et al. Clin Gastroenterol Hepatol. 2012;10:1239-45 300 * 700 * 250 600 200 500 400 150 300 100 200 50 100 0 Run-in Placebo Buspirone 0 Run-in Placebo Buspirone Intragastric volume (ml) Accommodation (ml) 40 Accommodation Postprandial volume threshold 35 30 ➢ Double-blind, 25 *† Run-in placebo-controlled, 20 *† Placebo crossover study * Buspirone 15 * n=17 (13 women; Symptom scoreSymptom mean age, 38.5 10 years) 5 ➢ Buspirone (10 mg, 0 3 times daily for 4 Fullness Bloating Belching Nausea Pain Epigastric weeks) burning Functional dyspepsia management By definition: NO cause known ➢Why do PPIs work if gastric acid not increased? And why possibly better in PDS than pain? ➢Why might H. pylori eradication work in a subset if gastritis is not the cause of symptoms? ➢Prokinetics and antidepressants can reduce symptoms but do not modify the natural history of the disease ➢Are alternative treatment options emerging? Clin Gastroenterol Hepatol. 2007 5:1175-83 MBP – degranulation in FD may be key… S100 nerve fibresS100 Clusters of eosinophils in D1 observed in 26 FD Carbol (51%) vs. 10 controls (21%) (p=0.003) ChromotropeEosinophil
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