Sunday, February 18, 2007

 

omeprazole en NSAID's

Research article
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Maintenance treatment with esomeprazole following initial relief of NSAID-associated upper GI symptoms - the NASA2 and SPACE2 studies
Christopher J Hawkey , Nick J Talley , James M Scheiman , Roger H Jones , Goran Langstrom , Jorgen Naesdal , Neville D Yeomans and Nasa/space Author group

Arthritis Research & Therapy 2007, 9:R17 doi:10.1186/ar2124

Published 9 February 2007


Abstract (provisional)



The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.



Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase (COX)-2 inhibitors, cause upper gastrointestinal (GI) symptoms that are relieved by treatment with esomeprazole. We assessed esomeprazole for maintaining long-term relief of such symptoms. 610 patients with a chronic condition requiring anti-inflammatory therapy who achieved relief of NSAID-associated symptoms of pain, discomfort or burning in the upper abdomen during two previous studies were enrolled and randomised into two identical, multicentre, parallel-group, placebo-controlled studies of esomeprazole 20 mg or 40 mg treatment (NASA2 and SPACE2, study codes SH-NEN-0002 and SH-NEN-0004, respectively) performed at various rheumatology, gastroenterology and primary care clinics. 426 patients completed the 6-month treatment period. The primary measure was the proportion of patients with relapse of upper GI symptoms, recorded in daily diary cards, after 6 months. Relapse was defined as moderate-to-severe upper GI symptoms (a score of ^33 on a 7-grade scale) for 3 days or more in any 7-day period. Esomeprazole was significantly more effective than placebo in maintaining relief of upper GI symptoms over 6 months treatment. Life table estimates (95% confidence intervals) of the proportion of patients with relapse at 6 months (pooled population) were: placebo, 39.1% (32.2-46.0%); esomeprazole 20 mg, 29.3% (22.3-36.2%) p=0.006 vs. placebo; esomeprazole 40 mg, 26.1% (19.4-32.9%) p=0.001 vs. placebo. Patients on either non-selective NSAIDs or selective COX-2 inhibitors appeared to benefit. The frequency of adverse events was similar in all three groups. Esomeprazole maintains relief of NSAID-associated upper GI symptoms in patients taking continuous NSAIDs, including selective COX-2 inhibitors. ClinicalTrials.gov identifiers: NASA2, NCT00241514 and SPACE2, NCT00241553

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