Improvements with Esomeprazole in Patients with Upper Gastrointestinal Symptoms Taking Non-Steroidal Antiinflammatory Drugs, Including Selective COX-2 Inhibitors

Hawkey, Chris; Talley, Nicholas J; Yeomans, Neville D; Jones, Roger; Sung, Joseph J.Y.; Långström, Göran; Næsdal, Jørgen; Scheiman, James M
May 2005
American Journal of Gastroenterology;May2005, Vol. 100 Issue 5, p1028
Academic Journal
OBJECTIVES: Upper gastrointestinal (GI) symptoms are common in patients using non-steroidal antiinflammatory drugs (NSAIDs) including selective cyclooxygenase (COX)-2 inhibitors and may be acid related. We therefore assessed esomeprazole treatment for upper GI symptoms in these patients.METHODS: A total of 794 and 848 continuous NSAID users, free of gastroduodenal ulcers, erosive esophagitis, andHelicobacter pylori,were enrolled into two identical, multinational, multicenter double-blind studies (NASA1, SPACE1). Moreover, 608 and 556 patients were randomized to receive 4 wk esomeprazole 20 mg, or 40 mg, or placebo once daily. The primary variable was the patient-reported change in the upper GI symptom (pain, discomfort, or burning in the upper abdomen) score on a 7-graded severity scale (0–6) from the 7 days prior to treatment to the last 7 days in the study.RESULTS: Esomeprazole was associated with highly significant symptom improvement compared to placebo. Symptom improvements were 2.30 mean[SD 1.63] on esomeprazole 20 mg and 2.03[1.56] on esomeprazole 40 mgversus1.64[1.57] on placebo in NASA1 and 2.17[1.34] and 2.12[1.48] versus1.56[1.26], respectively, in SPACE1 (all placebo comparisons at leastp<0.001). Esomeprazole-improved symptoms in patients taking selective COX-2 inhibitors, with changes of 2.21[1.46] and 1.92[1.38] versus1.64[1.46] in NASA1 and 2.20[1.26] and 2.24[1.62] versus1.58[1.37] in SPACE1 (all placebo comparisons at leastp<0.05), as well as those on non-selective NSAIDs. Esomeprazole was well tolerated and associated with significant improvements in HRQL.CONCLUSION: Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.(Am J Gastroenterol 2005;100:1028–1036)


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