Original Contribution
The American Journal of Gastroenterology (2005) 100, 1028–1036; doi:10.1111/j.1572-0241.2005.41465.x
Improvements with Esomeprazole in Patients with Upper Gastrointestinal Symptoms Taking Non-Steroidal Antiinflammatory Drugs, Including Selective COX-2 Inhibitors
Chris Hawkey MD1, Nicholas J Talley MD1, Neville D Yeomans MD1, Roger Jones DM1, Joseph JY Sung MD1, Göran Långström BSc1, Jørgen Næsdal MD1 and James M Scheiman MD1 on behalf on the NASA1 SPACE1 Study Group*
1Institute of Clinical Research Trials Unit, University Hospital, Nottingham, UK; Mayo Clinic College of Medicine, Rochester, Minnesota; Department of Medicine, University of Melbourne, Victoria, Australia; GKT Department of General Practice, King's College, London, UK; Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong; AstraZeneca R&D, Mölndal, Sweden; Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Michigan
Correspondence: Prof. C Hawkey, Institute of Clinical Research Trials Unit, Wolfson Digestive Diseases Centre, University Hospital, Derby Road, Nottingham, NG7 2UH, United Kingdom
*The following authors were in the group (country coordinating investigators and top recruiters compose the NASA1 SPACE1 study group): Dr. Johannes Habbig, Dr. Francis Philippe, Dr. Jaques Tondut, Dr. A Halland, Dr. C van Rensburg, Dr. Jeff Karrasch, Dr. Hans Larnefelt, Dr. Walter Kean, Dr. Olav Bjørneboe, Dr. A Halland, Dr. Kjell-Arne Ung, Dr. Gabriele Bianchi Porro, Dr. A Patel, Dr. Dariusz Kleczkowski, Dr. Pavla Vav
incová, Dr. Jozef Rovenský, Dr. Fabien Labie, Dr. Wolfgang Bolten, Dr. Angel Lanas, Prof. Jean-François Bergmann, and Dr. Demeter Pál.
Received 8 September 2004; Revised 0000; Accepted 16 December 2004.
Abstract
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, 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.
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 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.
CONCLUSION:
Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.
