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.
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.