Nexium Can Reduce Stomach Ulcer in High Risk Patients

Results from two clinical trials, to be published in the April 2006 edition of the American Journal of Gastroenterology, indicate that NEXIUM® (esomeprazole magnesium) can reduce the incidence of gastric (stomach) ulcers in patients at risk of developing gastric ulcers and who regularly take either non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs.

NSAIDs are a class of pain relief medications that include traditional, non-selective drugs, such as ibuprofen, naproxen and aspirin, and newer COX-2-selective agents. Non-selective NSAIDs are known for increasing the risk of gastric ulcers, particularly among older patients who take them regularly or who have a history of gastric ulcers.

Pooled data from the double-blind, randomized, six-month trials showed that significantly fewer patients taking either NEXIUM 20 mg or NEXIUM 40 mg, in addition to their regular non-selective NSAID/COX-2-selective therapy, developed an ulcer at six months, compared to those taking a placebo (5.2 percent and 4.6 percent, respectively, vs. 17 percent, p<0.001). These differences were seen as early as the first month of treatment and maintained throughout the study duration.

"Paradoxically, NSAID use is common among patients at high risk for gastric ulcers or other complications associated with these medications. Although COX-2-selective drugs generally cause fewer gastric ulcers than non-selective NSAIDs, these events aren't completely eliminated, and the residual side-effect rate still may be high," said James M. Scheiman, MD, Division of Gastroenterology, Department of Internal Medicine, University of Michigan. "Data from the two trials showed that NEXIUM was effective in reducing stomach ulcers in at-risk patients who require chronic NSAID treatment."

In the first trial, known as Verification of Esomeprazole for NSAID Ulcers and Symptoms (VENUS), a significantly smaller percentage of patients taking NEXIUM 20 mg or 40 mg developed a gastric or duodenal (occurring in the beginning of the small intestine) ulcer, compared to patients on placebo (5.3 percent and 4.7 percent, respectively, versus 20.4 percent, p<0.001 and p<0.0001). In the second trial, Prevention of Latent Ulceration Treatment Options (PLUTO), the ulcer rates were 5.2 and 4.4 percent for patients on NEXIUM 20 mg and 40 mg, respectively, versus 12.3 percent for those on placebo (p=0.018 and p=0.007).

About the Trials

The two studies were similar, double-blind, randomized, placebo-controlled trials involving a total of 844 (U.S.) and 585 (multinational) patients who were randomly assigned in a 1:1:1 ratio to treatment with either NEXIUM 20 mg, NEXIUM 40 mg or a placebo. Patients were continuous NSAID users (i.e., receiving daily non-selective NSAID or COX-2 therapy for at least four weeks before and throughout the duration of the six-month trial) at risk of developing a gastric or duodenal ulcer as a result of older age (>60 years) and/or a history of previous gastric ulcers. At the time of the study, patients were free of ulcers and Helicobacter pylori infection and showed no evidence of GI bleeding or perforation within the prior six months.