New study shows erosive esophagitis healing linked to acid control

May 22, 2006

Los Angeles, CA - New clinical data demonstrated, for the first time in a prospective study, a direct relationship between controlling gastric (or stomach) acid and healing erosive esophagitis caused by acid reflux disease. The results of the trial, which included more than 100 patients treated with NEXIUM® (esomeprazole magnesium), were presented Sunday at the annual Digestive Disease Week® (DDW®).

Results from the multi-site, four-week, double blind trial demonstrated that patients were more likely to achieve healing of erosive esophagitis (EE) if their gastric acid was well controlled after five days of therapy. Gastric acid control was defined as intragastric pH > 4. In patients who were healed of EE acid was well controlled through day five an average of 61.3 percent of the time, compared to 42.1 percent of the time in unhealed patients; p=0.0002. A post hoc analysis showed that healed patients also experienced a longer duration of acid control in the esophagus (95.2 percent of a 24-hour period) compared to unhealed patients (88.9 percent of a 24-hour period), a statistically significant difference (p=0.0059). Better acid control also correlated to significantly lower heartburn and acid regurgitation symptom scores (Spearman rank correlation [r] = -29 percent and -21 percent; p=0.003 and 0.032, respectively).

"This is the first prospective study that showed an association between control of intragastric pH and clinical outcomes in GERD patients," said Philip Katz, MD, lead author of the study. "The results further support intragastric pH as a surrogate marker for assessing the efficacy of antisecretory therapy in GERD."

Acid reflux disease is frequent persistent heartburn (burning pain and pressure in the center of the chest) on two or more days a week. It occurs when the valve between the esophagus and stomach stops closing properly, allowing acid to leak back into the esophagus. About one in three people with frequent, persistent heartburn also experience erosive esophagitis, in which over time stomach acid begins to wear away, or erode, the inner lining of the esophagus. Since the frequency or severity of heartburn a person experiences does not reflect the presence of erosions, only a doctor can determine if damage has occurred.

Study Details
The trial was a double-blind, prospective study to assess the relationship between the amount of time intragastric pH > 4 and healing in adult patients with endoscopically verified grade C or D of erosive esophagitis (EE), according to the Los Angeles Classification System for grading esophageal inflammation. This system categorizes patients by grades of severity (A-D), with grades A and B indicating mild erosive esophagitis and grades C and D representing severe disease. Patients were randomly given either NEXIUM® 10 mg or 40 mg once daily for four weeks. NEXIUM belongs to a class of acid-suppressing drugs known as proton pump inhibitors (PPIs). The study was not designed to compare the doses but rather to investigate a broad range of acid control. NEXIUM 10mg is not an approved dose. These drugs reduce acid by blocking the action of tiny "pumps" within the acid-secreting cells of the stomach.

Patients underwent an intraesophageal/intragastric 24-hour pH study on day five. When assessing acid control, clinicians measure pH on a 14-point scale, with 7 being neutral and lower numbers being more acidic. At week four, an endoscopist blinded to the pH study evaluated whether or not each patient's erosive esophagitis had healed. In addition, investigators scored patients' acid reflux disease symptoms before treatment and at four weeks, before the final endoscopy. Analyses included patients who completed the pH study and final endoscopy, and met predetermined protocol criteria (n=103). Of this group, 72 patients had healed erosive esophagitis at four weeks.
-end-
The study was sponsored by AstraZeneca.

About NEXIUM® (esomeprazole magnesium) delayed-release capsules
NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions. NEXIUM also is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcer.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. For full prescribing information for NEXIUM please visit www.nexium-us.com.

About Digestive Disease Week®
Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW® takes place May 21-25 in Los Angeles. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

About AstraZeneca
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 world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: www.astrazeneca-us.com.

AstraZeneca

Related Esophagus Articles from Brightsurf:

Updated Barrett's Guideline aims to improve patient outcomes
The American Society for Gastrointestinal Endoscopy (ASGE) has released its updated 'ASGE guideline on screening and surveillance of Barrett's esophagus,' published in the September issue of GIE: Gastrointestinal Endoscopy.

Results of early endoscopic exam critical for assessment of Barrett's patients
A new study indicates that both high-grade abnormal cellular changes (dysplasia) and esophageal adenocarcinoma (a form of cancer) have increased in the last 25 years among people with a digestive condition known as Barrett's esophagus.

Does work stress increase cancer risk?
In an International Journal of Cancer study of data on more than 280,000 people from North America and Europe, work stress was associated with a significantly increased risk of colorectal, esophagus, and lung cancers.

Cancer-associated mutations are common in normal human esophagus
Unexpectedly, a new study finds that cancer-associated genetic mutations are surprisingly common in aged, healthy esophageal epithelium tissue.

Scientists grow human esophagus in lab
Scientists working to bioengineer the entire human gastrointestinal system in a laboratory now report using pluripotent stem cells to grow human esophageal organoids.

New recommendations for endoscopic eradication therapy in Barrett's esophagus
A new guideline by the ASGE Standards of Practice Committee offers evidence-based recommendations and clinical guidelines addressing key issues related to Endoscopic Eradication Therapy (EET) in the management of Barrett's esophagus (BE)-related lesions.

Researchers develop swallowable test to detect pre-cancerous Barrett's esophagus
Investigators at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center have developed a simple, swallowable test for early detection of Barrett's esophagus that offers promise for preventing deaths from esophageal adenocarcinoma.

New studies add to understanding of treatments for Barrett's esophagus
The October issue of GIE: Gastrointestinal Endoscopy features several new studies evaluating various treatments for Barrett's esophagus (BE).

Robots offer key advantages in esophageal surgery
Robotics provide better visuals and allow lymph node removal with fewer incisions.

Oxford University Press to publish Diseases of the Esophagus
Oxford University Press and the International Society for Diseases of the Esophagus (ISDE) are pleased to announce their new partnership to publish Diseases of the Esophagus, ISDE's monthly scientific journal.

Read More: Esophagus News and Esophagus Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.