SOURCE: Given Imaging

Given Imaging

November 02, 2011 07:00 ET

New Studies Show GERD Is Best Assessed Off PPI Therapy

NATIONAL HARBOR, MD--(Marketwire - Nov 2, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that two studies confirming the appropriate use of Bravo wireless pH monitoring for the assessment of gastroesophageal reflux disease (GERD) were presented at the American College of Gastroenterology meeting today. Given Imaging is exhibiting at booth #1601 throughout the conference.

  • Poster presentation, P18, entitled, "Impedance-pH Monitoring: Comparison to a Symptom-Based Reflux Disease Questionnaire (GerdQ) for the Identification of Gastroesophageal Reflux Disease," concluded that evaluating patients off proton pump inhibitor (PPI) therapy is more likely to provide clinically useful information compared to evaluating patients on PPI therapy. The 85-patient study prospectively evaluated the association between GerdQ scores, based upon a standard 6-item questionnaire aimed at identifying patients with GERD, and the results of impedance-pH monitoring in patients studied either on or off acid suppression. Sixty percent of the patients studied remained on PPI therapy while undergoing pH monitoring. Among the patients studied off therapy, a GerdQ score greater than or equal to eight (≥8) showed 100 percent sensitivity for identifying abnormal acid exposure time compared to 75 percent sensitivity for patients who remained on PPI therapy.

    The conclusions of the study align with a consensus statement developed by a group of 13 leading esophagologists in a white paper written last year. The white paper recommended that patients stop PPI use seven days prior to undergoing first-line, ambulatory pH monitoring.
  • Poster presentation, P15, entitled, "Wireless pH Capsule Testing: The Effects of Diabetes and Narcotic Use and the Safety of Clopidogrel and Warfarin During Testing," concluded that results of wireless pH monitoring were not affected by the use of narcotics or a co-existing diabetic condition and that routinely stopping clopidogrel for wireless pH capsule testing may not be necessary. The aim of the 1,754 patient study was to evaluate the impact of diabetes and narcotic use on wireless pH monitoring in patients either on or off acid suppression, and to evaluate the safety of wireless pH monitoring in patients taking clopidogrel or warfarin. Patients remained on clopidogrel during the study but stopped warfarin three days in advance of the test. Studies were completed off PPI therapy in 69 percent of patients. pH assessments in patients with either type I or type II diabetes were not different compared to patients without diabetes, which is noteworthy since diabetic patients often experience motility abnormalities.

"As we learn more about the risks inherent with long-term use of PPI therapy, obtaining a definitive diagnosis confirming a patient's gastroesophageal reflux disease, or GERD, becomes increasingly important," said Brian E. Lacy, MD, Director, Gastrointestinal Motility Lab, Dartmouth-Hitchcock Medical Center. "It is critical that pH tests available are being used optimally so that physicians can ensure the most accurate diagnosis and offer their patients the best options for care."

Several other studies presented at the meeting addressed the use and misuse of PPI therapy, including an Italian study concluding that PPI use in the general population is extensive and long-term in nature, with 60 percent of long-term users inappropriately diagnosed and 47 percent prescribed PPIs inappropriately, including 17 percent who are prescribed PPIs without any diagnosis specified. A different large study confirmed that suboptimal administration of PPIs is more prevalent among primary care physicians compared to GI specialists and that consumers who purchased over-the-counter PPIs were the least likely to use the medication optimally, contributing to greater disease burden.

About Gastroesophageal Reflux Disease
Gastroesophageal reflux (also known as heartburn) occurs when contents from the stomach flow back up into the esophagus. Occasional heartburn is normal, but chronic heartburn caused by GERD can affect daily activities and damage the esophagus. Left untreated, GERD may also lead to more serious medical problems:

  • Difficulty swallowing (dysphagia)
  • Painful swallowing (odynophagia)
  • Narrowing of the esophagus (strictures)
  • Barrett's esophagus (pre-cancerous lesion)
  • Chronic hoarseness or laryngitis
  • Respiratory problems (coughing, asthma)

About the Bravo pH Monitoring System
The Bravo pH Monitoring System is the only catheter-free pH test, using a capsule that collects and transmits pH data via radio frequency telemetry to a small, external, pager-sized receiver worn by the patient. Like catheter-based pH tests, the Bravo pH Monitoring System is an ambulatory method of pH monitoring, considered the gold standard for pH measurement and monitoring of gastric reflux. The Bravo pH Monitoring System collects data that are more reflective of the patient's normal daily routine to assess if the patient has GERD.

The Bravo system allows patients to maintain their regular diet and activities. The Bravo system also minimizes throat and nasal discomfort associated with conventional catheter-based pH systems. With little visible indication that a pH test is taking place, Bravo pH monitoring eliminates the social embarrassment that accompanies traditional pH testing. The Bravo pH Monitoring System extends pH data collection to 48 hours or more, twice the recording capability of conventional catheter systems. Bravo provides physicians with additional data needed for an accurate GERD assessment. Current studies show that Bravo increases the likelihood of GERD diagnosis based on acid exposure and confirms that prolonged 48-hour monitoring facilitates the documentation of relationships between symptoms and reflux events, as reported first in a 2003 study published in The American Journal of Gastroenterology1. The Bravo system is the subject of more than 50 peer-reviewed and industry publications.

Traditional pH testing studies, sometimes combined with impedance measurement, involve the insertion of a very small catheter into the nostril and advancing it into the esophagus, where it stays throughout the 24-hour testing period. Patients using the catheter method often do not follow their usual daily schedule so the pH measurements may not be predictive of GERD during the 24-hour testing period. Challenges to traditional catheter based pH testing include throat irritation, difficulty sleeping and discomfort during eating and drinking.

About Given Imaging Ltd.
Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States.], industry-leading ManoScan high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam and Hong Kong. For more information, please visit www.givenimaging.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations, (18) quality issues and adverse events related to our products, such as capsule retention, aspiration and failure to attach or detach, bleeding or perforation that could require us to recall products and impact our sales and net income, and (19) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2010. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

1 Am J Gastroenterol 2003;98(4):740-749.

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