Two clinical trials found that Esomeprazole ( Nexium ) can reduce the incidence of gastric 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.

Pooled data from the double-blind, randomized, six-month trials showed that significantly fewer patients taking either Esomeprazole 20 mg or Esomeprazole 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, at University of Michigan.
“ Data from the two trials showed that Esomeprazole was effective in reducing stomach ulcers in at-risk patients who require chronic NSAID treatment.”

In the first trial, known as VENUS ( Verification of Esomeprazole for NSAID Ulcers and Symptoms ), a significantly smaller percentage of patients taking Esomeprazole 20 mg or Esomeprazole 40 mg developed a gastric or duodenal 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, PLUTO ( Prevention of Latent Ulceration Treatment Options ), the ulcer rates were 5.2 and 4.4 percent for patients on Esomeprazole 20 mg and Esomeprazole 40 mg, respectively, versus 12.3 percent for those on placebo ( p=0.018 and p=0.007 ).

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 Esomeprazole 20 mg, Esomeprazole 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 gastrointestinal bleeding or perforation within the prior six months.

Source: American Journal of Gastroenterology, 2006


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