2004 4056S1 01 C Novartis Unmet Need

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Published on October 29, 2007

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Chronic Constipation: An Unresolved Problem for Many Patients:  Chronic Constipation: An Unresolved Problem for Many Patients Charlene Prather, MD Division of Gastroenterology and Hepatology Saint Louis University School of Medicine Presentation Objectives:  Presentation Objectives Definition of chronic constipation Epidemiology and resource utilization Review of available therapies and limitations Unmet medical need C Definition: Causes of Chronic Constipation:  Definition: Causes of Chronic Constipation Secondary Drug induced Metabolic factors Comorbid conditions Primary Impaired colonic transit/motility Altered neuroenteric function and reflexes Failure of muscular apparatus Ineffective defecation (functional outlet obstruction) Pelvic dyssynergia and anismus Normal transit constipation C Constipation Is a Constellation of Symptoms:  Constipation Is a Constellation of Symptoms Most commonly reported symptoms Hard, lumpy stools Increased straining Infrequent bowel movements Sensation of incomplete evacuation Bloating/fullness Chronic constipation More persistent than intermittent or episodic Several months duration C Constipation Is More Than Just Infrequent Passage of Stool:  Sandler RS, et al. Dig Dis Sci. 1987;32:841-845. n = 1128 Constipation Is More Than Just Infrequent Passage of Stool 53 Constipation symptoms reported most often Reduced Stool Frequency Is Not the Most Commonly Reported Symptom in Constipation:  Reduced Stool Frequency Is Not the Most Commonly Reported Symptom in Constipation EPOC = Epidemiology of constipation; BM = Bowel movement. 1. Stewart WF, et al. Am J Gastroenterol. 1999;94:3530-3540. 2. Paré P, et al. Am J Gastroenterol. 2001;96:3130-3137. Stewart (EPOC) 19991 Paré 20012 n = 1476 n = 1149 Constipation symptoms reported most often C Rome II Defines Functional Constipation Based on Multiple Symptoms:  Rome II Defines Functional Constipation Based on Multiple Symptoms Rome II diagnostic criteria for functional constipation At least 12 wk, which need not be consecutive, over the past 12 months of 2 or more of Straining* Lumpy or hard stools* Sensation of incomplete evacuation* Sensation of anorectal obstruction/blockage* Manual maneuvers to facilitate defecation* < 3 defecations/wk Loose stools not present Insufficient criteria for IBS * > 1/4 of defecations. Drossman DA, et al. In: Rome II: The Functional Gastrointestinal Disorders. 2000:382-391. C Prevalence in the General Population:  Prevalence in the General Population 1. Stewart WF, et al. Am J Gastroenterol. 1999;94:3530-3540. 2. Drossman DA, et al. Dig Dis Sci. 1993;38:1569-1580. 3. Harris Interactive Study, Wave 2. Data on file. 4. Paré P, et al. Am J Gastroenterol. 2001;96:3130-3137. 53 Approximately 25% of Sufferers Seek Care:  Approximately 25% of Sufferers Seek Care 1. Stewart WF, et al. Am J Gastroenterol. 1999;94:3530-3540. 2. Drossman DA, et al. Dig Dis Sci. 1993;38:1569-1580. 3. Harris Interactive Study, Wave 2. Data on file. 4. Paré P, et al. Am J Gastroenterol. 2001;96:3130-3137. 53 Constipation Affects All Age Groups:  Constipation Affects All Age Groups 53 Canadian population. Paré P, et al. Am J Gastroenterol. 2001;96:3130-3137. N = 1149 n = 378 n = 367 n = 217 n = 187 Epidemiology:  Epidemiology Chronic constipation is common Slightly more common in women F/M ratio = range 1.3 to 2.5 Affects all age groups Stewart WF, et al. Am J Gastroenterol. 1999;94:3530-3540. Paré P, et al. Am J Gastroenterol. 2001;96:3130-3137. Sandler RS, et al. Dig Dis Sci. 1987;32:841-845. C Profile of a Typical Chronic Constipation Patient in My Practice:  Profile of a Typical Chronic Constipation Patient in My Practice Generally female Symptomatic for > 10 yr Majority have tried lifestyle changes, fiber, and OTC laxatives prior to seeking care Manages condition with multiple therapies Most often referred by a primary care physician Copes with condition, but is not completely satisfied C Constipation Can Have a Negative Impact on Quality of Life:  Constipation Can Have a Negative Impact on Quality of Life In Olmstead County, Minnesota, people with CC reported significant impairment in QoL on SF-36 scale (n = 126)1 In Canada, people with self-reported or Rome II constipation had significantly worse SF-36 scores than the normal population (n = 472)2 In Australia, people with constipation had significantly worse SF-12 scores on both mental and physical scales (n = 227)3 1. O’Keefe EA, et al. J Gerontol A Biol Sci Med Sci. 1995;50:M184-M189. 2. Irvine EJ, et al. Am J Gastroenterol. 2002;97:1986-1993. 3. Koloski NA, et al. Am J Gastroenterol. 2000;95:67-71. C Constipation Significantly Impacts Healthcare Utilization:  Constipation Significantly Impacts Healthcare Utilization 5.7 million constipation-related outpatient visits annually1,2 4.1 million physician office-based visits 991,000 emergency room visits 587,000 hospital outpatient visits $2752/patient for tertiary care evaluation3 1. National Ambulatory Medical Care Survey, 2001. www.cdc.gov 2. National Hospital Ambulatory Care Survey, 2001. www.cdc.gov 3. Rantis PC Jr, et al. Dis Colon Rectum. 1997;40:280-286. C Goal of Therapy in Chronic Constipation:  Goal of Therapy in Chronic Constipation The goal of therapy is to improve GI function in order to provide relief of key symptoms: Straining Hard/lumpy stools Feeling of incomplete evacuation Infrequent bowel movements Bloating/fullness 53 Medications Commonly Used for Constipation:  Medications Commonly Used for Constipation Fiber Laxatives Osmotic laxatives Stimulant laxatives Enemas or suppositories Miscellaneous 53 Adapted from Lembo A, et al. N Engl J Med. 2003;349:1360-1368. Efficacy of Current Treatments for Chronic Constipation :  Efficacy of Current Treatments for Chronic Constipation Variable treatment responses For the constellation of constipation symptoms, efficacy not evaluated or demonstrated with most agents Most agents indicated for ≤ 2 wk of treatment 53 Petticrew M, et al. Qual Health Care. 2001;10:268-273. Jones MP, et al. Dig Dis Sci. 2002;47:2222-2230. Rao SS. Gastroenterol Clin North Am. 2003;32:659-683. Limitations of Current Treatments for Constipation:  Limitations of Current Treatments for Constipation Worsening of some constipation symptoms Bloating and gas Cramping, abdominal pain/colic Development of complications Diarrhea, hypovolemia Metabolic disturbances Other adverse effects Interference with concomitant drug absorption Structural changes in gut mucosa Abuse potential (dependency) Diminished therapeutic effect over time C Xing JH, et al. Dis Colon Rectum. 2001 Aug;44:1201-1209. Garcia MC, et al. Tenn Med. 2002 Aug;95:334-336. Chaussade S, et al. Aliment Pharmacol Ther. 2003 Jan;17:165-172. Riley SA, et al. Br J Clin Pharmacol. 1992 Jul;34:40-46. Gattuso JM, et al. Drug Saf. 1994 Jan;10:47-65. Wald A. J Clin Gastroenterol. 2003;36:386-89. Duncan A, et al. Eur J Gastroenterol Hepatol. 2001;13:599-601. Physicians Believe Patient Satisfaction With Current Therapies Is Low:  Physicians Believe Patient Satisfaction With Current Therapies Is Low Yes 18% Are your patients completely satisfied? No 82% Schiller LR, et al. Am Coll Gastroenterol. 2004, abstract submitted. C n = 311 60% of physicians agreed that they do not have adequate products 90% of physicians wanted better treatment options Physicians cited “frustration with current treatments” one of the top 3 reasons patients state for seeking care *Not mutually exclusive. Many Constipation Patients Are Not Satisfied With Available Treatments:  Many Constipation Patients Are Not Satisfied With Available Treatments C 1. Schiller LR, et al. Am Coll of Gastroenterol. 2004, abstract submitted. 2. Irvine EJ, et al. Am J Gastroenterol. 2002;97:1986-1993. 3. Ferrazzi S, et al. Can J Gastroenterol. 2002;16:159-164. *Not mutually exclusive. Yes 53% Are you completely satisfied? 1 No 47% n = 557 Chronic Constipation: A Condition in Need of a Better Approach:  Chronic Constipation: A Condition in Need of a Better Approach Characterized by a constellation of symptoms High resource utilization and significant negative impact on patients’ lives Current pharmacologic agents have limitations Many patients are not satisfied with available therapies Better treatment options are needed C

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