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A Clinical Reprint N Engl J Med. 2010; 362: 1597-1604. Helicobacter pylori Infection Kenneth E. L. McColl, M.D. Medical Device Division of Otsuka America Pharmaceutical, Inc. Helicobacter pylori Infection • • • • • A 29-year-old man with intermittent epigastric discomfort [< 55 years old with dyspepsia] There is no weight loss or evidence of GI bleeding [No alarm features] He reports no use of aspirin or NSAIDs A serologic test for H. pylori is positive [Passive test vs. active test] The patient returns with the same symptoms after one H. pylori course of standard triple therapy [Eradication rate and confirmation of eradication] This review article highlights... • the need for proper testing for H. pylori infection, • current eradication therapy options and limitations, and • the need for confirming eradication using the right test at the right time Clinical Problem Infection with H. pylori is a cofactor in the development of three important upper gastrointestinal diseases: • Duodenal or gastric ulcers (reported to develop in 1 to 10% of infected patients) • Gastric cancer (in 0.1 to 3%) • Gastric mucosa-associated lymphoid-tissue (MALT) lymphoma (in < 0.01%) “H. pylori infection is classified as a human carcinogen by the World Health Organization.” Testing for H. pylori Infection Testing should be done on patients with: • Confirmed gastric or duodenal ulcers • Gastric MALT lymphoma • Resection of early gastric cancers • Uninvestigated, uncomplicated dyspepsia Non-invasive testing can be performed with the use of: • Urea breath test • Fecal antigen test • Serologic test (the least accurate) The 13C urea breath test and the fecal antigen test have a sensitivity and specificity of 95% Commercially available quantitative serologic assays showed an overall sensitivity and specificity of only 85% and 79%, respectively H. pylori Eradication Eradication therapy is prescribed for patients with positive test results. Eradication: • Provides a long-term cure of duodenal ulcers in those not associated with the use of NSAIDs • Reduces the progression of atrophic gastritis • Causes regression of most localized gastric MALT lymphoma Various drug regimens are used to treat H. pylori infection, but the eradication rate of the standard triple therapy is only about 77%. It is important to confirm the eradication of H. pylori infection by means of: • Urea breath test • Fecal antigen test • Endoscopy These tests should be performed 4 weeks or longer after completion of therapy to avoid false negative results. Available Tests for Helicobacter pylori Infection* Non-endoscopic Serologic test Widely available; the least expensive of available tests Positive result may reflect previous rather than current infection; not recommended for confirming eradication Urea breath test (Active test) High negative and positive predictive values; useful before and after treatment False negative results possible in the presence of PPIs or with recent use of antibiotics or bismuth preparations; considerable resources and personnel required to perform test Fecal antigen test (Active test) High negative and positive predictive values with monoclonal-antibody test; useful before and after treatment Process of stool collection may be distasteful to patient; false negative results possible in the presence of PPIs or with recent use of antibiotics or bismuth preparations Urease-based tests (Active test) Rapid, inexpensive, and accurate in selected patients False negative results possible in the presence of PPIs or with recent use of antibiotics or bismuth preparations Histologic assessment Good sensitivity and specificity Requires trained personnel Culture Excellent specificity; provides opportunity to test for antibiotic sensitivity Variable sensitivity; requires trained staff and properly equipped facilities Endoscopic * PPI denotes proton-pump inhibitor. Conclusions and Recommendations Non-invasive test-and-treat strategy for H. pylori infection is reasonable for younger patients who have upper GI symptoms, but not alarm symptoms. Non-invasive testing can be performed with the use of the urea breath test, fecal antigen test, or serologic test; the serologic test is the least accurate. Further eradication therapy should not be considered unless persistent H. pylori infection is confirmed. The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13 CO2 to 12CO2 in breath samples, in clinical laboratories or point-of-care settings. The BreathTek UBT Kit is for administration by a health care professional, as prescribed by a physician. Please see IMPORTANT SAFETY INFORMATION on the back cover. Important Safety Information Intended Use: The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories or point-of-care settings. The BreathTek UBT Kit is for administration by a health care professional, as prescribed by a physician. Warnings and Precautions: 1. For in vitro diagnostic use only. The Pranactin®-Citric solution is taken orally as part of the diagnostic procedure. 2. Phenylketonurics: Contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.) 3. Blood glucose: Use with caution in diabetic patients. Pranactin-Citric contains Aspartame. 4. A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate methods. 5. False negative test results may be caused by: • Ingestion of antimicrobials, proton pump inhibitors, and bismuth preparations within 2 weeks prior to performing the BreathTek UBT • Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result • Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori. 6. False positive test results may be caused by: • Urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii • Achlorhydria. 7. If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used. 8. Hypersensitivity: Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the drug solution as this drug solution contains these ingredients. 9. Risk of Aspiration: Use with caution in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions. 10. Pregnancy: No information is available on use of the Pranactin-Citric solution during pregnancy. Postmarketing Experience During post-approval use of the BreathTek UBT, the following adverse events have been identified: anaphylactic reaction, hypersensitivity, rash, burning sensation in the stomach, tingling in the skin, vomiting and diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure. Limitations: 1. The BreathTek UBT should not be used until 4 weeks or more after the end of treatment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results. 2. The specimen integrity of breath samples and reference gases stored in breath bags under ambient conditions has not been determined beyond 7 days. 3. A correlation between the number of H. pylori organisms in the stomach and the BreathTek UBT result has not been established. Patient Preparation: 1. Remind the patient that Pranactin-Citric contains phenylalanine (one of the protein components of Aspartame). Phenylketonurics restrict dietary phenylalanine. 2. The patient should have fasted at least 1 hour before administering the BreathTek UBT. 3. The patient should not have taken antimicrobials, proton pump inhibitors, or bismuth preparations within 2 weeks prior to administering the BreathTek UBT. 4. For administration by a healthcare professional only. Do not provide this kit to the patient for self-administration. October 2012 0512L-5944 Please see current Package Insert in inside pocket. To learn more, call 1-888-637-3835, or visit www.BreathTek.com. Medical Device Division of Otsuka America Pharmaceutical, Inc. October 2012 ©2012 Otsuka America Pharmaceutical, Inc., Rockville, MD Printed on recycled paper 0512D-5941 Printed in USA