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What is the Value of Noninvasive Testing for Active Infection?

Understanding the Diagnosis of H. pylori:. What is the Value of Noninvasive Testing for Active Infection?. Syed Wahab, M.S. Department of Pathology Forum Health, Northside Medical Center 1. Clinical and Economic Impact of PUD H. pylori Infection.

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What is the Value of Noninvasive Testing for Active Infection?

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  1. Understanding the Diagnosisof H. pylori: What is the Value ofNoninvasive Testing for ActiveInfection? Syed Wahab, M.S. Department of Pathology Forum Health, Northside Medical Center1

  2. Clinical and Economic Impact of PUD H. pylori Infection. • More than 25 million Americans will develop peptic ulcer disease (PUD) at some point during their lifetime • 700,000 Endoscopies every year • H. pylori is associated with >80% of duodenal ulcers • 3.8 Million Prescriptions/ year • PUD costs approximately $6 billion annually in the US

  3. H. pylori Bacteria • Gram negative • Spiral rod • Unipolar flagella • Microaerophilic • Urease positive* *Most important character *Scanning microscopic view of H. pylori

  4. H. Pylori: Gastric biopsy H & E stain H. pylori immunostain

  5. H. pylori Infection • Transmissible • Oral-oral and oral-fecal • Infects the human stomach • Produces inflammatory response • This brings up the point of the importance of “hand washing”

  6. H. pylori Infection The bad news • High morbidity • Chronic and acute gastritis • Peptic ulcers • Gastric cancer • Classified by WHO as a Class I carcinogen

  7. H. pylori Infection The best news is: • It is curable

  8. Indications for H. pylori testing • Dyspepsia in primary care setting. • Documented gastric and duodenal ulcer. • History of peptic ulcer. • Gastric Mucosa-Associated Lymphoma. • After resection of early gastric adenocarcinoma. • First-degree relative of a patient with gastric cancer.

  9. Outcomes of H. pylori Infection • Often asymptomatic (latent), but not benign, • with progressive gastric damage1 • Dyspepsia1 • PUD2: duodenal and gastric ulcers (17%) • Life-threatening complications occur in 1%-2% of patients with peptic ulcer disease per year • Gastric cancer3 • Mucosa-associated lymphoid tissue (MALT)/primary gastric B-cell lymphoma3 1. Malfertheiner P et al. Aliment Pharmacol Ther. 2002;16:167. 2. Nomura A et al. Annals of Int Med. 1994;120:977. 3. Parsonnet J et al. N Engl J Med. 1994;330:1267.

  10. Outcomes of H. pylori Infection Latest research suggests • ~45% of babies with Colic have H. pylori. • Eradication of H. pylori in Glaucoma improved eyesight significantly. • H. pylori is involved in some cardiac conditions.

  11. H Pylori Disease Associations • Migraine Headaches • Glaucoma • Stroke • Morning Sickness • SIDS • Negative Cardiac Assesments

  12. Prevalence of H. pylori Infection • Varies geographically • May be as high as 52% in the U.S. • 80-90% in developing countries. Graham DY et al. Gastroenterology. 1991;100:1495.

  13. Prevalence of H. pylori Infection • 50% of people over 60 years of age and 8%-20% of those younger than 60 are infected • High prevalence in minorities and immigrants from developing countries *Vaira et al, Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay. The Lancet, Vol 354, July 3, 1999.

  14. H. pylori Infection Risk Factors • Low socioeconomic status • Crowded or unsanitary living conditions • Born in a developing country • Born before 1950 • Children in the family • Exposure to gastric contents • Nurses • Endoscopists Graham DY et al. Gastroenterology. 1991;100:1495.

  15. Current Trends in Management of Dyspepsia Undifferentiated dyspepsia Empiric trial of H2 blocker or Proton Pump Inhibitor (PPI) Symptoms persist? Meurer LN, Bower DJ. Am Fam Physician. 2002;65:1327.

  16. Recommended Management of Dyspepsia Undifferentiated dyspepsia Empiric trial of H2 blocker or Proton Pump Inhibitor (PPI) Symptoms persist? Yes Test for H. pylori Positive Eradication therapy Negative GI referral or long-term PPI therapy Meurer LN, Bower DJ. Am Fam Physician. 2002;65:1327.

  17. Problems with CurrentManagement of Dyspepsia • Many patients with dyspepsia are infected with H. pylori1 • PPIs mask the symptoms of H. pylori; they do not cure the underlying disease2,3 • PPIs may worsen corpus histology2,3 • Cure reduces healthcare costs by avoiding further morbidity and mortality4 • 90% of patients with PUD do not experience a recurrence after H. pylori eradication 1. Talley NJ et al. Aliment Pharmacol Ther. 1999;12:1135. 2. Graham DY, et al. Aliment Pharmacol Ther. 2003;17:193 . 3. Larkin CJ, et al. Scand J Gastroenterol. 2000;35:578. 4. Sonnenberg A, Townsend WF. Arch Intern Med. 1995;155:922.

  18. Recommended Management of Dyspepsia Undifferentiated dyspepsia Empiric trial of H2 blocker or Proton Pump Inhibitor (PPI) Symptoms persist? Yes Test for H. pylori No Routine follow-up Positive Eradication therapy Negative GI referral or long-term PPI therapy Meurer LN, Bower DJ. Am Fam Physician. 2002;65:1327.

  19. Indications for Noninvasive Testing for H. pylori* • Strongly Recommended • Dyspepsia • History of/active peptic ulcer disease • Gastric MALT lymphoma • Following gastric cancer resection • Following peptic ulcer surgery • First-degree relative with gastric cancer • Long-term Non-steroidal anti-inflamatory drugs (NSAID) therapy * In the absence of alarm signs for gastric cancer or ulcer disease 1. Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167. 2. Talley NJ et al. Aliment Pharmacol Ther. 1999;12:1135.

  20. Indications Noninvasive Testing for H. pylori*(cont.) • Advisable • Family history of duodenal ulcer • Family members with H. pylori infection • GERD requiring long-term PPI therapy * In the absence of alarm signs for gastric cancer or ulcer disease Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167. 2.Talley NJ et al. Aliment Pharmacol Ther. 1999;12:1135.

  21. Why Test Patients with GERD? • Reflux symptoms have been shown to improve when H. pylori is eradicated1 • Patients with GERD and H. pylori infection experience decreased frequency of hospital visits and use of antiacid medications when H. pylori is eradicated1 • Prevents exacerbation of corpus gastritis by PPIs in patients with H. pylori 2,3 1. Miwa H, et al. Helicobacter. 2002;7:219. 2. Graham DY, et al. Aliment Pharmacol Ther. 2003;17:193 3. Larkin CJ, et al. Scand J Gastroenterol.2000;35:578.0

  22. Why Test Chronic NSAID Users? • NSAID use can cause gastric mucosal injury; H. pylori predisposes to increased damage from NSAIDs1-4 • H. pylori infection increases the risk of an NSAID ulcer complication 2-4 fold4 • H. pylori eradication in chronic NSAID users is suggested5 1. Chan FK, et al. Lancet. 1997:350:975. 2. Feldman M, et al. Am J Gastroenterol. 2001;96:1751. 3. Chan FK, et al. New Engl J Med. 2001;344:967. 4. Huang JQ, et al. Lancet. 2002;359:14. 5. Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167.

  23. Suggested Guidelines forTreatment of Patients with GI or Ulcer Disease History & Physical Exam Undifferentiated dyspepsia Symptoms of GERD Use of NSAIDs or aspirin Peptic ulcer disease Test for H. pylori Positive Eradication therapy Confirmation of cure Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167.

  24. Suggested Guidelines forTreatment of Patients with GI or Ulcer Disease History & Physical Exam Undifferentiated dyspepsia Symptoms of GERD Use of NSAIDs or aspirin Peptic ulcer disease Test for H. pylori Positive Eradication therapy Confirmation of cure Negative Treat for PUD, Initiate PPI therapy, or discontinue NSAIDs Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167.

  25. Endoscopy Rapid urease tests Histology Culture Serologic (antibody) Stool antigen tests 13C Urea blood test Urea breath tests 14C-urea 13C-urea Types of H. pylori Tests Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167.

  26. Endoscopy • Histology is often considered a gold standard for detection of H. pylori infection1,2 • Used for patients with symptoms of complicated ulcer, alarm symptoms, or long-standing GERD to rule out Barrett’s esophagus1,3 • Invasive1-3 • Costly1 1. Meurer LN, Bower DJ. Am Fam Physician. 2002;65:1327. 2. Cutler AF et al. Gastroenterology. 1995;109:136. 3. Chey WD. Practical Gastroenterol. 2001;April:28.

  27. Serology • Serum antibody tests • Detect antibodies to present or past H. pylori infection1 • Cannot distinguish between active and past infection2 • Pretest probability is critical for interpretation1,3,4 1. Loy CT et al. Am J Gastroenterol. 1996;91:1138. 2. CheyWD, Fendrick AM. Arch Intern Med. 2001;161:2129. 3. Vaira D, Vakil N. Gut. 2001;48:287. 4. Cutler AF et al. Gastroenterol. 1995;109:136.

  28. Stool Antigen Test • Detects H. pylori protein antigens as the marker of infection1 • Detects active infection1 • Compliance issues2 • Recommended in Maastricht 2-2000 Consensus Report3 1. Matsuda M, et al. J Gastroenterol. 2003;38:222. 2. Chey WD. Practical Gastroenterol. 2001;April:28. 3. Malfertheiner P et al. Aliment Pharmacol Ther. 2002;16:167.

  29. HpSATM Microtiter wells and HpSATM Immunocard kits.

  30. HpSATM Microtiter wells

  31. HpSATM Immunocard Control Line (Green) Test Sample Test Line (Red)

  32. 14C Urea Breath Test • Measures urease activity using • 14C isotope1,2 • Detects active infection1,2 • Radioactive1,2 • Not recommended for women of childbearing age1,2 • H2 blockers affect test reliability3 • Not approved for post-treatment monitoring3 1. CheyWD. Practical Gastroenterol. 2001;April:28. 2. Peura DA et al. Am J Gastroenterol. 1996;91:233. 3. PYtest [prescribing information]. 1997.

  33. 13C Urea Blood Test • Detects active infection1,2 • Nonradioactive1,2 • Requires mass spectrometer2 • “Gray zone” in which positive and negative cannot be distinguished2 • 5%-10% false-negative rate2 1. CheyWD. Practical Gastroenterol. 2001;April:28. 2. Ez-HBT [prescribing information]. 2003.

  34. Test for the Active Disease and the Cure

  35. 13C Urea Breath Test • Detects active infection • Sensitive and specific • Non-radioactive • No special handling requirements • Easy to collect and handle sample • Not indicated in pediatric population 1. Graham DY et al. Am J Gastroenterol. 2001;96:1741. 2. Leodolter A et al. Am J Gastroenterol. 1999;94:2100.

  36. Tests for H. pylori Infection:Active vs. Serology Testing Active Disease Testing

  37. Tests for H. pylori Infection:Active vs. Serology Testing Patient management More cost-effective 250 200 150 30 25 20 Dollars % Total Patients Active disease test Serology test Active Testing Antibody Testing

  38. Summary RegardingH. pylori Testing • Testing for H. pylori in patients who have symptoms or are at risk for H. pylori reduces health care costs by preventing further morbidity • Several noninvasive tests for H. pylori infection are available • Tests can be categorized as detecting • active infection or identifying presence of antibodies against H. pylori

  39. Suggested Steps in Management of H. pylori Diagnosis Therapy Confirm cure Malfertheiner P, et al. Aliment Pharmacol Ther. 2002;16:167.

  40. Confirmation of Cure ofH. pylori Infection • Active tests must be used • Cannot use serology • Risks of not testing • Recurrent ulcer • Ulcer complications, gastric cancer • Transmission to others Chey WD. Practical Gastroenterol. 2001;April:28.

  41. HpSA UBT Diagnosis Not affected by meds Off PPI’s for 1 weeks Monitoring FDA cleared for therapeutic monitoring PPI’s may interfere with FDA cleared for use Test of Cure 1 week; meds do not interfere 4 weeks; no meds Cross reactivity None Other urea producers may interfere HpSA vs. UBT

  42. HpSA UBT Pediatrics Indicated for use Not indicated for use Special equipment None Mass or IR spec l HpSA vs. UBT Accuracy relative to gold standard Excellent Excellent Drinking an Isotopic Carbon (C13) solution Yuck factor Collecting stool Stability of specimen 1-2 days at R.T. 7 days

  43. Conclusions • H. pylori is a transmissible, infectious disease with potentially serious outcomes • H. pylori infection may be asymptomatic or cause dyspepsia • Eradication therapy can cure H. pylori infection and prevent morbidity and downstream events such as PUD and gastric cancer • Patients with symptoms of upper-GI disease, and who use aspirin or NSAIDs should be tested for H. pylori infection

  44. Conclusions (cont.) • Several noninvasive tests to detect H. pylori infection are available • Categorized as detecting active infection or identifying the presence of antibodies against H. pylori • Active tests of infection are required for post-treatment confirmation of cure of H. pylori infection

  45. H. Pylori testing • Before I end: • Thanks to Dr. Ortega for the invitation. • Thanks to Meretek and Meridian for helping in this presentation. • And a special thanks to Mindy Borowski. • Thanks to all of you for being here.

  46. References • Meridian research • The prevalence of H.pylori in peptic ulcer disease. Aliment Pharmacol Ther.1995. • CDC H.pylori fact sheet, www.cdc.gov • Fendrick, Mark et al, Guide to diagnosing H.pylori infection in primary care, Health Communications, 1998. • Goldstein et al, Reduced Risk of upper gastroenterological ulcer complications with celecoxib, a novel COX-2 inhibitor, Am J G 2000;95:1681-690. • Marshland, DW et al, Content of Family Practice. J Fam Prac 1976; 3:37-68. • National Institute of Diabetes and Digestive and Kidney Disorders, NIH Pub. No. 95-38; Jan 1995.

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