Study Calls For Better Treatment And Understanding Of H. Pylori

Meretek Diagnostics Inc., manufacturer of the BreathTek(TM) UBT (urea breath test) kit for the bacterium Helicobacter pylori (H. pylori), said a newly published study clearly shows cause for concern with non-compliance in the diagnosis and treatment of H. pylori infections.

The study, supported by Meretek Diagnostics and published in the January 2007 issue of the American Journal of Managed Care (AJMC)(1), found that about one third of patients treated for H. pylori were not tested for infection prior to treatment, and less than 15 percent of patients treated for the bacteria were tested after treatment to confirm eradication.

Clinical practice guidelines for dyspepsia -- stomach pain and discomfort -- have been in place for more than a decade. In November 2005, the American Gastroenterological Association (AGA) updated its position statement on the evaluation of dyspepsia to recommend that patients 55 years of age or younger without alarm symptoms should be tested using a test of active infection, such as the 13C-urea breath test(2).

"The guidelines for testing and treatment of this infection are there," said Colin W. Howden, M.D., F.A.C.G., study co-author and Professor, Division of Gastroenterology, Northwestern University. "But, in many cases, those guidelines are not followed. There's a lot more work to do to get the message out about the clinically appropriate test and treat guidelines."

H. pylori is the primary cause of peptic ulcer disease (PUD). About 1 in 3 adults in the U.S. is infected with H. pylori and one in ten Americans may develop a peptic ulcer over their lifetime. Eradication therapy fails in 1 in 4(3). The only non invasive tests cleared for initial diagnosis and test for cure are the urea breath test and stool antigen test.

The study marks the first large-scale national study of clinical testing and treatment patterns for dyspepsia and upper gastrointestinal symptoms.

"It's a well-designed, national study," said Meretek President and Chief Executive Officer Ryuichi Kishigami. "This shows that managed care as well our own industry needs to do a better job of educating physicians, distributors and laboratories about the proper diagnosis and treatment of H. pylori."

The retrospective study was based on analysis of paid medical and pharmacy claims of more than 2 million people continuously enrolled in 75 commercial managed care plans across the U.S.

The study also found that, in those 14 percent of patients tested after treatment, one third of those patients seeing a primary care practitioner incorrectly received a serologic (blood) test. This is despite the fact that serologic tests cannot differentiate between a past infection and current infection and that they are not FDA-approved to test for cure.

Additionally, the study reported:

-- 18 percent of patients with gastroesophogeal reflux disease (GERD) were inappropriately tested for H. pylori

-- Only about two thirds of patients who should have had endoscopy based on age (50 - 64 years old) and symptoms (presumed PUD) actually received one

-- One third of patients aged 18 - 49 with symptoms, for whom endoscopy is generally not recommended, underwent endoscopy within 30 days of being seen for dyspepsia

About Meretek Diagnostics

Located in Lafayette, Colo., Meretek Diagnostics Inc. is a subsidiary of Otsuka America, a healthcare company engaged in the development of advanced, non-invasive, non-radioactive breath tests and instrumentation. Meretek was founded in 1993 by a group from the Baylor College of Medicine in Houston, Texas. The company holds exclusive licenses to patents involving the 13C urea breath test technologies, and all of the their products are approved by the FDA.

For more information about Meretek Diagnostics, Inc. and the company's products, including prescribing information, warnings and limitations, visit the Meretek Web site at http://www.meretek.com/.

(1) Am J Manag Care. 2007;13:1, 37-44
(2) Gastroenterol. 2005;129:1753-1755
(3) Cleve Clin J Med 2005; 72:S8-S13

Meretek Diagnostics Inc.
http://www.meretek.com/