Efficacy of esomeprazole for resolution of symptoms of heartburn and acid regurgitation in continuous users of non-steroidal anti-inflammatory drugs C. J. HAWKEY*, R. H. JONES  , N. D. YEOMANS à , J. M. SCHEIMAN§, N. J. TALLEY – , J. L. GOLDSTEIN**, H. AHLBOM   & J. NÆSDAL    *Institute of Clinical Research Trials Unit, University Hospital, Notting- ham;  GKT Department of General Practice and Primary Care, King’s Col- lege London, London, UK; àUniversity of Western Sydney Medical School, Sydney, Australia; §Division of Gas- troenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI; –Mayo Clinic College of Medicine, Rochester, MN; **Depart- ment of Medicine, University of Illi- nois at Chicago, Chicago, IL, USA;   AstraZeneca R&D, Mo ¨ lndal, Sweden Correspondence to: Prof C. Hawkey, Institute of Clinical Research Trials Unit, University Hospital, Derby Road, Nottingham, NG7 2UH, UK. E-mail: cj.hawkey@nottingham.ac.uk Publication data Submitted 19 July 2006 First decision 28 July 2006 Resubmitted 19 October 2006 Resubmitted 21 November 2006 Accepted 21 November 2006 SUMMARY Background The use of non-steroidal anti-inflammatory drugs (NSAIDs) is often associated with upper gastrointestinal symptoms such as heartburn and acid regurgitation. Aim To assess the efficacy of esomeprazole 20 and 40 mg for resolution of heartburn and acid regurgitation in continuous NSAIDs. Methods A post hoc analysis of five clinical trials was performed. Two identically designed, placebo-controlled, 4-week studies (NASA1, SPACE1) enrolled non-ulcer, NSAIDs-treated patients with upper abdominal pain, dis- comfort or burning. PLUTO and VENUS were identically designed, placebo-controlled, 6-month studies that enrolled patients at risk of NSAIDs-induced ulcers. Study 285 was an 8-week comparative study with ranitidine (300 mg/day) in patients with NSAIDs-induced gastric ulcers. Resolution of investigator-assessed heartburn and acid regurgitation was defined as symptom severity of ‘none’ in the last 7 days. Results In NASA1/SPACE1, heartburn resolved in 61% and 62% of patients taking esomeprazole 20 and 40 mg, respectively (vs. 36% on placebo, P < 0.001), and acid regurgitation resolved in 65% and 67% (vs. 48%, P < 0.001). Resolution of both symptoms was greater with esomeprazole than with placebo in PLUTO/VENUS (P £ 0.001), and than with raniti- dine in study 285 (P < 0.05 for esomeprazole 20 mg). Conclusion Heartburn and regurgitation are common in patients taking NSAIDs and esomeprazole is efficacious for resolution of these symptoms. Aliment Pharmacol Ther 25, 813–821 Alimentary Pharmacology & Therapeutics ª 2007 The Authors 813 Journal compilation ª 2007 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2006.03210.x