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*
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