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

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. A total of 794 and 848...

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Bibliographic Details
Published in:	The American journal of gastroenterology Vol. 100; no. 5; pp. 1028 - 1036
Main Authors:	HAWKEY, Chris, TALLEY, Nicholas J, YEOMANS, Neville D, JONES, Roger, SUNG, Joseph J. Y, LANGSTRÖM, Göran, NAEDAL, Jørgen, SCHEIMAN, James M
Format:	Journal Article
Language:	English
Published:	Oxford Blackwell Publishing 01-05-2005 Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
Subjects:	Aged Anti-Inflammatory Agents, Non-Steroidal - adverse effects Anti-Ulcer Agents - therapeutic use Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents Cyclooxygenase 2 Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors - adverse effects Double-Blind Method Esomeprazole - therapeutic use Female Follow-Up Studies Gastroenterology Gastroesophageal Reflux - prevention & control Heartburn - prevention & control Humans Isoenzymes - antagonists & inhibitors Male Medical sciences Membrane Proteins Middle Aged Nausea - prevention & control Pain - prevention & control Peroxidases - antagonists & inhibitors Pharmacology. Drug treatments Placebos Prostaglandin-Endoperoxide Synthases - adverse effects Quality of Life Treatment Outcome Upper Gastrointestinal Tract - drug effects Human Enzyme Antiinflammatory agent H Enzyme inhibitor Antiulcer agent K Gastrointestinal Proton pump inhibitor Symptomatology Improvement Benzimidazole derivatives Antisecretory agent Esomeprazole exchanging ATPase Hydrolases
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Summary:	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. A total of 794 and 848 continuous NSAID users, free of gastroduodenal ulcers, erosive esophagitis, and Helicobacter 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. 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 mg versus 1.64 [1.57] on placebo in NASA1 and 2.17 [1.34] and 2.12 [1.48]versus 1.56 [1.26], respectively, in SPACE1 (all placebo comparisons at least p < 0.001). Esomeprazole-improved symptoms in patients taking selective COX-2 inhibitors, with changes of 2.21 [1.46] and 1.92 [1.38]versus 1.64 [1.46] in NASA1 and 2.20 [1.26] and 2.24 [1.62]versus 1.58 [1.37] in SPACE1 (all placebo comparisons at least p < 0.05), as well as those on non-selective NSAIDs. Esomeprazole was well tolerated and associated with significant improvements in HRQL. Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.
ISSN:	0002-9270 1572-0241
DOI:	10.1111/j.1572-0241.2005.41465.x