RSS Feeds

Email a Friend Printer Friendly

New Study on confirmatory Test Diagnosis for GastroEsophageal Reflux Disease

May 22, 2001

22 May 2001 - Mölndal, Sweden - The majority of patients presenting with chronic and frequent heartburn will be eventually diagnosed with gastroesophageal reflux disease (GERD). At present, the only means to confirm a suspected diagnosis, made by a physician following an analysis of symptom history, is endoscopy or pH monitoring, both expensive procedures often only available after a long wait. Currently, each year, endoscopic procedures cost US $ 22.6 million in Sweden alone.1

However, new data, presented today at the Digestive Diseases Week, Atlanta, USA suggests that patients presenting with chronic heartburn and free of alarm symptoms* could be prescribed a standard dose of esomeprazole (Nexium® 40mg) once daily for just one-week. 2 If the frequency and intensity of heartburn substantially decreases during that one-week period, a diagnosis of GERD can be accurately confirmed. For the patients, the major advantage is rapid freedom from the pain of heartburn without an inconvenient endoscopy.

Results of the robust 34-centre randomised, double-blind trial, involving 440 patients, demonstrated that a confirmatory test with esomeprazole 40mg once-daily has a high sensitivity in confirming GERD.2 Esomeprazole was chosen as the trial reference drug, because it has been shown to relieve heartburn symptoms faster and for longer than the previous gold standard PPI, omeprazole. Investigators concluded that a one-week treatment period was sufficient to confirm the diagnosis.

Previous large multi-centre studies have demonstrated that with esomeprazole 40mg, the median time to sustained symptom resolution (defined as the first day of the
heartburn free period) is 5 days, with 47 percent of GERD patients experiencing their first resolution from heartburn (defined as first day without heartburn) within 24 hours.3
"The ability to diagnose with confidence and to simultaneously treat a patient's pain is immensely valuable to physicians", said Professor Jan Hatlebakk, University of Bergen, Norway, a lead investigator in the trial.
In the study, GERD was judged to be confirmed in patients who had a mucosal break at endoscopy and / or an intraesophageal pH below 4 for more than one hour in a 24 period. In more than 86% of patients diagnosed with GERD via endoscopy or pH monitoring, the disease could be diagnosed through the evaluation of symptom improvement, following treatment with esomeprazole 40mg once daily, compared to symptoms recorded on the third day. 2 Hence these results show an esomeprazole test can be reliably used as a non-invasive test for GERD.

In a review, published recently in the BMJ, it was noted that GERD symptoms have a significant negative impact on quality of life, notably on measures of pain, mental health and social function, yet less than half of all GERD patients display diagnostic endoscopic abnormalities. Therefore, the authors conclude, endoscopy has a limited role in the diagnosis of GERD.4

Professor John Dent, University of Adelaide, and one of the authors of the BMJ article, emphasises: "While endoscopy is useful in some patients to identify complications of the esophagitis or in assessing the severity of the disease, most GERD patients can be managed empirically, at least initially."

Some physicians believe that endoscopy should play a central role in the management of GERD, a view usually not supported by specialist gastroenterologists. The authors of the BMJ review believe that routine follow-up endoscopy is not usually justified if symptoms resolve with treatment. 4 It is,
however, hotly debated amongst experts whether endoscopy should be done, at least once, to screen for Barrett's esophagus, because the increased risk that
this relatively uncommon complication of GERD carries for the development of esophageal cancer.
Esomeprazole is currently used in the treatment of erosive reflux esophagitis, the long-term management of patients with healed esophagitis to prevent relapse, and the symptomatic treatment of GERD. If Nexium does not resolve heartburn symptoms after four weeks patients should be referred for further investigation. Esomeprazole is not approved as a diagnostic test for GERD.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services.   It is one of the top five pharmaceutical companies in the world, with leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

To learn more about Nexium® please visit our interactive website: www.nexiumpressoffice.com

- Ends -
For further enquires please contact:
Helen Mills, Global Public Relations Manager, GI AstraZeneca,
tel: +44 1625 519 514, mobile: +44 780 307 9354,
e-mail: helen.t.mills@astrazeneca.com







CPR Worldwide