Study compares stomach acid control of three proton pump inhibitors in chronic NSAID users

05/16/05

Analysis includes both COX-2 and non-selective NSAIDs

CHICAGO, IL, May 16th, 2005 ¡V Data from a clinical trial comparing stomach acid control of three proton pump inhibitors (PPIs), esomeprazole magnesium (NEXIUM®), lansoprazole (Prevacid), and pantoprazole (Protonix), in chronic users of non-steroidal anti-inflammatory drugs (NSAIDs) were presented today at the annual Digestive Disease Week® (DDW®). The analysis included users of traditional NSAIDs and selective COX-2 inhibitors.

The results of the multicenter, randomized, three-way, crossover study of 77 chronic users of COX-2 inhibitors or nonselective NSAIDs found that esomeprazole maintained a pH of greater than 4.0 for 17.8 hours (74.3 percent) of the 24-hour period while lansoprazole maintained it for 15.9 hours (66.4 percent, P=.0003)) and pantoprazole for 14.6 hours (60.7 percent, P<.0001).

"It is well known that long-term NSAID users are at increased risk for stomach ulcers, which is often a deterrent to long-term treatment. Acid control can reduce this risk and proton pump inhibitors have been shown to reduce the incidence of ulcers associated with chronic NSAID use," said Jay L. Goldstein, M.D., Professor of Medicine, Vice Head for Clinical Affairs, Department of Medicine, University of Illinois at Chicago and lead investigator for the study. "PPIs provide the acid control necessary to reduce the risk of stomach ulcers, allowing patients to continue the use of medications that provide them with pain and inflammation relief. This study compares the ability of three proton pump inhibitors to control stomach acid."

Approximately 70 percent of people over the age of 65 take NSAIDs at least once a week and nearly half of them take seven doses or more per week. NSAID use is one of the most common causes of gastroduodenal injury in the United States. Approximately half of all people who regularly take NSAIDs have gastric erosions and between 15 percent and 30 percent have ulcers.1

Study Details
Study participants were required to have a condition that required treatment with daily, prescription-strength doses of a COX-2 or nonselective NSAID for at least one month. They also were required to be free from Helicobacter pylori -- bacteria often associated with stomach ulcers.

Participants were randomly assigned to one of three treatment groups. Each treatment group received once-daily oral doses of esomeprazole (40 mg), lansoprazole (30 mg) or pantoprazole (40 mg) for five days followed by a 10-day break. The same regimen was followed for each of the two remaining treatments. Each treatment group received the study drugs in a different sequence. Pantoprazole is not indicated for risk reduction of NSAID-associated gastric ulcers.

By the end of the study, all patients received five-day courses of all three proton pump inhibitors. On day five of each treatment period, patients underwent a catheter- based 24-hour pH study to evaluate the percent of time gastric pH was greater than 4.0 (pH is measured on a 14-point scale with 7 being neutral and lower numbers being more acidic).

Among COX-2 users (e.g., Celebrex, Vioxx, and Bextra, n=38) esomeprazole maintained a pH of greater than 4.0 for 17.5 hours compared with 16.1 hours for lansoprazole and 14.6 hours for pantoprazole. Among users of nonselective NSAIDs (e.g., ibuprofen, naproxen, n=39) esomeprazole maintained a pH of greater than 4.0 for 18.1 hours compared with 15.8 for lansoprazole and 14.6 hours for pantoprazole.

The most common side effects of esomeprazole include headache, diarrhea and abdominal pain.

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 14-19, 2005 in Chicago. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

NEXIUM® (esomeprazole magnesium) delayed-release capsules
NEXIUM is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous 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. NEXIUM is also approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in 4 to 8 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.

For full prescribing information for NEXIUM please visit www.purplepill.com

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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 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.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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