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Practical Approaches Towards Improving Patient Outcomes for Chronic Constipation and Irritable Bowel Syndrome With Const

Practical Approaches Towards Improving Patient Outcomes for Chronic Constipation and Irritable Bowel Syndrome With Constipation (IBS-C) Among Older Adults. Educational Learning Objectives.

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Practical Approaches Towards Improving Patient Outcomes for Chronic Constipation and Irritable Bowel Syndrome With Const

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  1. Practical Approaches Towards Improving Patient Outcomes for Chronic Constipation and Irritable Bowel Syndrome With Constipation (IBS-C) Among Older Adults

  2. Educational Learning Objectives • Describe the elements of proper diagnosis and follow-up management of chronic constipation (CC) in older adults • Demonstrate awareness of the prevalence of irritable bowel syndrome-constipation (IBS-C) in older adults and the elements of differential diagnosis from CC • Discuss how management of CC and IBS-C varies based upon underlying etiologies and across the spectrum of older adults, from the active community dweller to the compromised long term care resident with multiple comorbidities • List common patient perceptions of constipation and describe how these may impact progress towards practitioners' clinical goals in CC and IBS-C • Identify patient education and counseling strategies that will allow advanced practice nurses (APN) to collaborate with patients and family members in the successful management of CC and IBS-C in older adults

  3. How Do We Define Constipation? • The American College of Gastroenterology (ACG) definition of constipation: • Unsatisfactory defecation characterized by infrequent stools, difficult stool passage, or both. Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to pass stool, or need for manual maneuvers to pass stool • The ACG Chronic Constipation Task Force also clarified what is meant by chronic: • Chronic constipation is defined as the presence of these symptoms for at least 3 months American College of Gastroenterology Chronic Constipation TaskForce. Am J Gastroenterol. 2005;100(S1):1-4.

  4. GI Symptoms Are Common in the Older Population • 35% to 40% of geriatric patients will have at least 1 GI symptom in any year • Constipation, fecal incontinence, diarrhea, irritable bowel syndrome, reflux disease, and swallowing disorders • Prevalence rates for constipation in the older adult population range from approximately 19% to 40% • Day Hospitals/Living at Home: 25–40% • Nursing Homes/Geriatric Hospitals: 60–80% • Irritable bowel syndrome presents in ~10% of the older population Hall KE, et al. Gastroenterology. 2005;129:1305-1338. Ginsberg D, et al. Urol Nursing. 2007;27:191-200. Morley J. Clin Geriatr Med. 2007;23:823-832.

  5. Overlap Between Common Disorders Bloating Constipation Chronic Constipation Dyspepsia IBS Discomfort Abdominal Pain GERD Regurgitation Heartburn Belching Brandt L, et al. Am J Gastroenterol. 2005;100(S1):5-22.

  6. (-) Abdominal Pain Chronic constipation Presence or absence of abdominal pain is the major differentiating feature Abdominal Pain: Salient Feature Absent in Chronic Constipation (+) Abdominal Pain IBS with constipation Brandt LJ, et al. Am J Gastroenterol. 2005;100(suppl 1):S5-S21.

  7. Prevalence of Functional Gastrointestinal Disorders 45 40 40 35 25-40 30 2-28 28 25 25 Population (%) 3-20 20 6-18 15 10 8 8 5 0 Dyspepsia FunctionalHeartburn ChronicConstipation GERD IBS Hyper- tension Migraine Asthma Diabetes Wong WM, Fass R. Curr Treat Options Gastroenterol. 2004;7(4):273-278. Corazziari E. Best Pract Res Clin Gastroenterol. 2004;18(4):613-631. Higgins PD, Johanson JF. Am J Gastroenterol. 2004;99(4):750-759. Brandt L, et al. Am J Gastroenterol. 2002;97(suppl11):S7-26. Wolf-Maier K, et al. JAMA. 2003;289:2363-2369. Lawrence EC. South Med J. 2004 Nov;97(11):1069-1077. CDC. MMWR Morb Mortal Wkly Rep. 2004;53:145-148. CDC. MMWR Morb Mortal Wkly Rep. 2003;52:833-837.

  8. Constipation Increases With Age and Is More Common in Women Study 1 N = 42,375 Harari, et al Population: NHIS 1989 Criteria: self-report Men Women 25 12 20 10 8 15 Prevalence of Constipation (%) Prevalence of Constipation (%) 6 10 4 5 2 0 0 ≥ 80 Study 2 Study 3 Study 4 < 40 40-49 50-59 60-69 70-79 N = 5,430 Drossman N = 1,149 Pare N = 10,018 Stewart Age Group (years) Sex NHIS = National Health Interview Survey Higgins PDR, et al. Am J Gastroenterol. 2004;99:750-759.

  9. Chronic Constipation Interferes with Daily Lives of the Aging Population • Impact of chronic constipation on quality of life in Olmsted County, MN, residents aged ≥ 65 years • Lower score indicates worse quality of life Constipation No GI symptoms 100 80 60 Mean MOS Score 40 20 0 Mental Health Physical Functioning Role Functioning Social Functioning Health Perception Bodily Pain MOS = medical outcomes survey Adapted from Talley NJ. Rev Gastroenterol Disord. 2004;4(suppl 2):S3-S10.

  10. Economic Impact of Constipation • 2.5 million office visits annually • 92,000 hospital admissions • 85% are given prescriptions for laxatives or cathartics • $400 million dollars spent in annually for prescription laxatives • $2253 average cost per long term care resident Economic Burden of Irritable Bowel Syndrome • IBS care: > $20 billion direct and indirect expenditures • Patients with IBS consume > 50% more health care costs than matched controls without IBS Tariq S. J Am Med Dir Assoc. 2007;8:209-218. Ginsberg D, et al. Urol Nursing. 2007;27(3):191-201. ACG IBS Task Force. Am J Gastroenterol. 2009;104:S1-S35.

  11. Normal Physiology of Defecation • Increased abdominal pressure or propulsive colorectal contractions • Relaxation of internal anal sphincter (autonomic) • Relaxation of external anal sphincter (voluntary) • Straightening of pelvic musculature (levator ani, puborectalis) At rest With straining Lembo A, Camilleri M. N Engl J Med. 2003;349:1360-1368. Muller-Lissner S. Best Pract Res Clin Gastroenterol. 2002;16:115-133.

  12. Mediators of Gastrointestinal Function Motility Serotonin Acetylcholine Nitric oxide Substance P Vasoactive intestinal peptide Cholecystokinin Corticotropin releasing factor Visceral Sensitivity Serotonin Tachykinins Calcitonin gene-related peptide Neurokinin A Enkephalins Corticotropin releasing factor Secretion Serotonin Acetylcholine Kim DY, Camilleri M. Am J Gastroenterol. 2000;95(10):2698-2709.

  13. Rome III Diagnostic Criteria*for Functional Constipation < 3 defecations per week Chronic constipation must include 2 or more of the following: During at least 25% of defecations Manual maneuvers to facilitate defecations Straining Lumpy or hard stools Sensation of incomplete evacuation • Sensation of anorectal obstruction/ • blockage • Loose stools are rarely present without the use of laxatives • Insufficient criteria for irritable bowel syndrome *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis Longstreth GF, et al. Gastroenterology. 2006;130:1480-1491.

  14. Primary Causes of Chronic Constipation • Normal-transit constipation • Slow-transit constipation • Defecatory dysfunction • IBS with constipation Bosshard W, et al. Drugs Aging. 2004;21:911-930. Hadley S.K, et al. Journal of Am Fam Physician. 2005;72:2501-2506.

  15. Primary Constipation • Normal-transit Constipation • – Intestinal transit and stool frequency are within the normal range • – Most frequent type of constipation Bosshard W, et al. Drugs Aging. 2004;21:911-930. Gallagher P, et al. Drugs Aging. 2008;25(10):807-821.

  16. Primary Constipation • Slow-transit Constipation • Characterized by prolonged intestinal transit time • Altered regulation of enteric nervous system • Decreased nitric oxide production • Impaired gastrocolic reflex • Alteration of neuropeptides (VIP, substance P) • Decreased number of interstitial cells of Cajal in the colon Lembo A, Camilleri M. N Eng J Med. 2003;349:1360-1368.

  17. Primary Constipation • Defecatory Dysfunction • – More common in older women – childbirth trauma • – Pelvic floor dyssynergia • – Contributing factors include anal fissures, hemorrhoids, rectocele, rectal prolapse, posterior rectal herniation • – Excessive perineal descent • – Pathogenesis may be multifactorial – structural problem • – Abnormal anorectal manometry and/or defecography [Role for biofeedback therapy] Bosshard W, et al. Drugs Aging. 2004;21:911-930. Hadley S.K, et al. Journal of Am Fam Physician. 2005;72:2501-2506.

  18. Primary Constipation • Irritable Bowel Syndrome (IBS) with Constipation • – Alterations in brain-gut axis • – Stress-related condition • – Visceral hypersensitivity • – Abnormal brain activation • – Altered gastrointestinal motility • – Role for neurotransmitters, hormones • – Presence of non-GI symptoms • Headache, back pain, fatigue, myalgia, dyspareunia, urinary symptoms, dizziness Videlock E, Chang L. Gastroenterol Clin N Am. 2007;36:665-685. Hadley SK, et al. Journal of Am Fam Physician. 2005;72:2501-2506.

  19. Rome III Criteria for IBS-C Recurrent abdominal pain or discomfort (an uncomfortable sensation not described as pain) at least 3 days per month in the last 3 months associated with 2 or more of the following: • Improvement with defecation • Onset associated with a change in frequency of stool • Onset associated with a change in form of stool Criteria must be fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening for patient eligibility Longstreth G, et al. Gastroenterology. 2006;130:1480-1491.

  20. 100 75 % Hard or Lumpy Stools 50 IBS-C IBS-M 25 IBS-U IBS-D 0 25 50 75 100 % Loose or Watery Stools Subtypes of IBS IBS-C: IBS with constipation IBS-U: Unsubtyped IBS IBS-M: IBS mixed IBS-D: IBS with diarrhea Longstreth G, et al. Gastroenterology. 2006;130:1480-1491.

  21. Combined Risk Factors for Constipation in the Elderly Population • Reduced fiber intake • Reduced liquid intake • Reduced mobility associated with functional decline • Decreased functional independence • Pelvic floor dysfunction • Chronic conditions • Parkinson’s disease • Dementia • Diabetes mellitus • Depression • Polypharmacy (both over the counter and prescription medications, such as NSAIDs, antacids, antihistamines, iron supplements, anticholinergics, opiates, Ca channel blockers, diuretics, antipsychotics, anxiolytics, antidepressants)

  22. Common Changes with Aging that Increase the Risk for Constipation • Decreased total body water • Decreased colonic motility* • Deterioration of nerve function • Increased pelvic floor descent • Decreased rectal compliance • Decreased rectal sensation • Age-related changes to the internal and external anal sphincter *Demonstrated in some, but not all studies Gallagher P, et al. Drugs Aging. 2008;25(10):807-821. Schiller L. Gastroenterol Clin N Am. 2001;30:497-515.

  23. Patient Care • Thorough patient history • Physical/abdominal/digital rectal exams • Evaluate symptoms in terms of diagnostic criteria • Chronic constipation/IBS-C • Assessment for red flags/alarm features • Need for additional testing • Treatment/Management plan

  24. Ask the Right Questions • Define the meaning of “constipation” • How long have you experienced these symptoms? • Frequency of bowel movements? • Abdominal pain? • Other symptoms? • What is most distressing symptom? • Manual maneuvers to assist with defecation? • Any limitation of daily activities? • Are you taking any medications? • What treatment have you tried? • What investigations have been done? Locke GR III, et al. Gastroenterology. 2000;119:1761-1778.

  25. Common Patient Descriptions of Constipation 90 81 80 Physicians think: < 3 BM per week 72 70 60 54 50 Percent of Patients 39 37 40 36 28 30 20 10 0 Straining Hard or lumpy stools Incomplete emptying Abdominal fullness or bloating < 3 BM per week Need to press on anus Stool cannot be passed N = 1149 Pare P, et al. Am J Gastroenterol. 2001;96:3130-3137.

  26. Stool Form Correlates With Intestinal Transit Time The Bristol Stool Form Scale Slow Transit Fast Transit Separate hard lumps Type 1 Sausage-like but lumpy Type 2 Sausage-like but with cracks in the surface Type 3 Type 4 Smooth and soft Soft blobs with clear-cut edges Type 5 Fluffy pieces with ragged edges, a mushy stool Type 6 Type 7 Watery, no solid pieces O’Donnell LJD, et al. BMJ. 1990;300:439-440.

  27. Consider Secondary Causes Drugs Opiates Antidepressants Anticholinergics Antipsychotics Antacids (Al, Ca) Ca channel blockers Iron supplements Psychological Depression Eating disorders Surgical Abdominal/pelvic surgery Colonic/anorectal surgery Lifestyle Inadequate fiber/fluid Inactivity Constipation Metabolic/Endocrine Hypercalcemia Hyperparathyroidism Diabetes mellitus Hypothyroidism Hypokalemia Uremia Addison’s Porphyria Gastrointestinal Colorectal: neoplasm, ischemia, volvulus, megacolon, diverticular disease Anorectal: prolapse, rectocele, stenosis, megarectum Neurological Parkinson’s Multiple sclerosis Autonomic neuropathy Aganglionosis (Hirschsprung’s, Chagas) Spinal lesions Cerebrovascular disease Systemic Amyloidosis Scleroderma Polymyositis Pregnancy Candelli M, et al. Hepatogastroenterology. 2001;48:1050-1057. Locke GR, et al. Gastroenterology. 2000;119:1761-1766.

  28. Digital Rectal Exam • Place patient in left lateral recumbent position • Visually inspect the perianal region • Fissures, hemorrhoids, masses, skin tags, or evidence of previous surgery, skin lesions • Stroke the perianal skin to elicit a reflex contraction of the external anal sphincter • Assess for paradoxical pelvic floor contraction (suggestive of pelvic floor descent) • Perform a digital assessment • Strictures, masses, a rectocele, and hemorrhoids • Examine stool for color and consistency • Check for occult blood Rao SSC. Gastroenterol Clin North Am. 2003;32:659-683. Locke GR III, et al. Gastroenterology. 2000;119:1761-1778.

  29. Any Alarm Symptoms?Are Diagnostic Tests Needed? • Hematochezia • Family history of colon cancer • Family history of inflammatory bowel disease • Anemia • Positive fecal occult blood test • “Unexplained” weight loss ≥ 10 pounds • Severe, persistent constipation that is unresponsive to treatment • New-onset constipation in an elderly patient Locke GR III, et al. Gastroenterology. 2000;119:1761-1778. Brandt LJ, et al. Am J Gastroenterol. 2005;100(suppl 1):S5-S21.

  30. ACG Task Force Recommendations on Diagnostic Testing • ACG task force does not recommend diagnostic testing in patients without alarm signs or symptoms • BUT routine colon cancer screening recommended for all patients aged ≥ 50 years (African Americans aged ≥ 45 years) • Diagnostic studies are indicated in patients with alarm signs or symptoms • Thyroid function tests • Measurements of • Calcium • Electrolytes Brandt LJ, et al. Am J Gastroenterol. 2005;100(suppl 1):S5-S21. Agrawal S, et al. Am JGastroenterol. 2005;100:515-523.

  31. Diagnostic Tests That May Be Performed After a Referral Rao SSC, et al. Am J Gastroenterol. 2005;100:1605-1615. Lembo A, Camilleri M. N Engl J Med. 2003;349:1360-1368. Winawer S, et al. Gastroenterol. 2003;124:544-560.

  32. Differentiating BetweenOccasional and Chronic Constipation

  33. Lifestyle Modifications Chung BD, et al. J Clin Gastroenterol. 1999;28:29-32. Dukas L, et al. Am J Gastroenterol. 2003;98:1790-1796. ACG Chronic Constipation Task Force. Am J Gastroenterol. 2005;100(suppl 1):S1-S4.

  34. Treating Constipation With Laxatives Gallagher P, et al. Drugs Aging. 2008;25:807-821.

  35. Laxatives

  36. Bulk Laxatives: Review of Efficacy Brandt LJ, et al. Am J Gastroenterol. 2005;100:S5-S21.

  37. Stool Softeners and Stimulant Laxatives: Review of Efficacy RCT = randomized controlled trial Brandt LJ, et al. Am J Gastroenterol. 2005;100:S5-S21.

  38. Osmotic Laxatives: Review of Efficacy Brandt LJ, et al. Am J Gastroenterol. 2005;100:S5-S21.

  39. PEG 3350 – 12-Month Study An Open-Label, Single Treatment Multi-Centre Study of 311 Patients (117 aged 65 and older) Percentage of Patients 2 monthsN = 250 4 monthsN = 217 6 monthsN = 203 9 monthsN = 185 12 monthsN = 180 Visits PEG 3350 was determined safe and effective for treating constipation in adult older patients for periods up to 12 months, with no signs of tachyphylaxis Di Palma J. Ailment Pharmacol Ther. 2006;25;703-708.

  40. Adverse Effects of Laxatives • Bulking agents • Bloating • Severe adverse events: esophageal and colonic obstruction, anaphylactic reactions • Osmotic laxatives • Possible electrolyte abnormalities, hypovolemia • Diarrhea (2% to 40% of PEG-treated patients) • Excessive stool frequency, nausea, abdominal bloating, cramping, flatulence • Stimulant laxatives • Abdominal discomfort, electrolyte imbalances, allergic reactions, hepatotoxicity Brandt LJ, et al. Am J Gastroenterol. 2005;100:S5-S21.

  41. Dangers of Saline Laxatives in the Elderly • Oral sodium phosphate products [Visicol®, OsmoPrep®, Fleet* Phospho-soda] for bowel cleansing • Black box warning for Visicol®, OsmoPrep® • Acute phosphate nephropathy • Patients with identifiable risk factors • Age > 55 • Baseline kidney disease • Hypovolemic, reduced intravascular volume • Bowel obstruction, active colitis • Using medications that affect renal perfusion or function *Withdrawn from the market Available at: http://www.fda.gov/cder/drug/infopage/OSP_solution/default.htm. Accessed April 2009.

  42. Are Patients Satisfied With Laxatives and Fiber? 100 OTC laxatives Prescription laxatives Fiber (n = 146) (n = 42) (n = 268) 80 79 80 75 71 67 66 60 60 52 50 50 50 Dissatisfied Patients (%) 44 40 20 0 Ineffective Relief of Constipation Ineffective Relief of Multiple Symptoms Lack of Predictability Ineffective Relief of Bloating Johanson JF and Kralstein J. Aliment Pharmacol Ther. 2007;25:599-608.

  43. Lubiprostone: A Chloride Channel Activator • Gastrointestinal-targeted bicyclic functional fatty acid • Activates ClC-2 chloride channels • Movement of Cl-, Na+, H2O follow • Increased luminal fluid secretion • Shortened colonic transit time • Indicated for: • Treatment of chronic idiopathic constipation (24 µg BID) in the adult population including age > 65 years (FDA approval 2006) • Treatment of irritable bowel syndrome with constipation (8 µg BID) in women ≥ 18 years (FDA approval 2008) Cuppoletti J, et al. Am J Physiol Cell Physiol. 2004;287:C1173-C1183. Amitiza PI. Available at: http://www.fda.gov/cder/foi/label/2008/021908s005lbl.pdf. Accessed April 2009.

  44. Lubiprostone: Stool Frequency in Patients Over 65 with Chronic Constipation Nonelderly lubiprostone 48 µg Elderly (≥ 65 years) lubiprostone 48 µg Elderly placebo Nonelderly placebo 6 * * * * 5 *P ≤ 0.03 †P < 0.0001 † † † 4 N = 57 (patients aged ≥ 65 years vs placebo) 3 Change from Baseline in SBM Frequency 2 1 0 Week 4 Week 1 Week 2 Week 3 SBM = spontaneous bowel movement Ueno R, et al. Annual Meeting of the American College of Gastroenterology; October 2006; Las Vegas, NV. Johanson J, et al. Am J Gastroenterol. 2008;103:170-177.

  45. Safety Profile of Lubiprostone • Well tolerated in 4 week and 6-12 month trials • Nausea, diarrhea, and headache • No clinically significant changes in serum electrolyte levels • Low likelihood of drug-drug interactions • Non-absorbed; works intraluminally and does not result in measurable blood levels Available at: http://www.fda.gov/cder/foi/label/2008/021908s005lbl.pdf. Accessed April 2009.

  46. + Response + Response Suggested Management Algorithm for Chronic Constipation Bleeding, anemia, weight loss, sudden change in stool caliber, abdominal pain Alarm Symptoms No Alarm Symptoms Lifestyle, OTC, stimulant laxative Directed testing Refer to a specialist as needed No Response Trial of lactulose or PEG 3350 Continue regimen + Response No response Trial of lubiprostone No response OTC = over-the-counter therapies (probiotics, herbal medications, stool softeners [docusate sodium], psyllium, methylcellulose, calcium polycarbophil, bisacodyl, senna)

  47. Treatment for IBS-C ACG IBS Task Force. Am J Gastroenterol. 2009;104:S1-S35.

  48. Treatment for IBS-C ACG IBS Task Force. Am J Gastroenterol. 2009;104:S1-S35.

  49. Lubiprostone for IBS-CData From 2 Phase 3 Studies Placebo N = 385 Lubiprostone (8 µg BID) N = 769 20 Note the different dose! For chronic constipation lubiprostone: 24 µg BID P = 0.001 15 10 Response Rate (%) 5 0 Combined intent to treat population Monthly responder for ≥ 2/3 months during treatment Drossman D, et al. Aliment Pharmacol Ther. 2009;29:329-341.

  50. Baseline Score 2.08 2.19 2.19 2.76 2.33 0 -0.2 -0.4 -0.6 Mean Change from Baseline -0.8 * -1.0 * * -1.2 * * -1.4 Abdominal Discomfort/Pain§ Bloating§ Constipation Severity§ Stool Consistency† Straining§ Nonresponder Responder Lubiprostone – Symptom Change IBS-C §Score: 0 (absent); 1 (mild); 2 (moderate); 3 (severe); 4 (very severe) †Score: 0 (very loose/watery); 1 (loose); 2 (normal); 3 (hard); 4 (very hard/little balls) * P < 0.001 Drossman D, et al. Aliment Pharmacol Ther. 2009;29:329-341.

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