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| |  DDW: Esomeprazole Maintains Dyspepsia Control in Patients on Nonsteroidal Anti-inflammatory Drugs for 6 Months By Bruce Sylvester NEW ORLEANS, LA. -- MAY 20, 2004 -- Esomeprazole (Nexium) 20 mg and 40 mg once daily (QD) is more effective than placebo in preventing relapses of upper gastrointestinal (GI) symptoms in users of nonsteroidal anti-inflammatory drugs (NSAID) during a 6-month period. Researchers reported these findings here on May 19th at the Digestive Diseases Week Annual Meeting. "NSAID-associated dyspepsia is common but relatively neglected, so the first most important fact is that this study is really the first, big systematic one to look at management," said lead investigator Christopher Hawkey, MD, Professor of Gastroenterology and Director, Institute of Clinical Research, University Hospital, University of Nottingham, Nottingham, United Kingdom. "We found was that acid suppression improved symptoms across all of the ways that we measured it," Dr. Hawkey said. "More importantly, though, this study shows that this improvement is maintained over 6 months. This was true for both non-selective NSAIDs and for selective COX-2 [cyclooxygenase-2] inhibitors. I think that this tells people how to manage dyspepsia with those groups of patients." Investigators enrolled 594 subjects who had achieved upper GI symptom relief (none/mild for last 7 days, maximum 2 days rated as mild) to be randomized into two identical, multicenter, placebo-controlled, double blind studies. They gave the subjects esomeprazole 20 mg or 40 mg once daily orally or placebo for 6 months. Subject kept diaries of upper GI symptoms (pain, discomfort or burning in the upper abdomen) and rating symptoms using a 7-grade scale ranging from "none" to "very severe". The researchers defined relapse as moderate or severe symptoms (a score of 3-6 for 3 days or more in any 7 day period). The primary end point was the proportion of patients with relapse of upper GI symptoms during the 6 months of study treatment. "The pooled [intention-to-treat] population comprised 594 patients [34% were taking only COX-2-selective NSAIDs]. Both doses of esomeprazole were significantly more effective than placebo in preventing the relapse of upper GI symptoms," the investigators reported. At end point, esomeprazole 20 mg and 40 mg also resulted in statistically significantly (P <.05) more patients than placebo who achieved no heartburn (20 mg 75.5%; 40 mg 81.3%; placebo 62.4%) or no acid regurgitation (20 mg 78.1%; 40 mg 86.5%; placebo 67.3%). "The results are similar across patients taking non-selective and COX-2-selective NSAIDs," the authors noted. "There are other studies in the works that will seek to confirm these findings, " Dr. Hawkey added. "But for right now the clinical implications from this highly-powered research for the use of this approved therapeutic agent are clear and, we believe, quite significant." The research was supported by AstraZeneca.
[Presentation title: "Maintained symptom control with esomeprazole following initial treatment of upper GI symptoms of patients on NSAIDs including COX-2-selective NSAIDs." Abstract #101579]
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