Esomeprazole for the Management of Upper Gastrointestinal Symptoms in Patients Who Require NSAIDs: A Review of the NASA and SPACE Double-Blind, Placebo-Controlled Studies

Background and Objective: Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of pain in rheumatic disorders and chronic pain syndromes. Their use is, however, limited by gastrointestinal (GI) toxicity, including upper GI symptoms, ulcers and related complications. Using...

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Bibliographic Details
Published in:Clinical drug investigation 2009-01, Vol.29 (10), p.677-687
Main Authors: Hawkey, Christopher J., Svedberg, Lars-Erik, Næsdal, Jørgen, Byrne, Claire
Format: Article
Language:English
Subjects:
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Complications and side effects
Dosage and administration
Dose-Response Relationship, Drug
Double-Blind Method
Esomeprazole - therapeutic use
Gastric Acid - metabolism
Gastrointestinal Diseases - chemically induced
Gastrointestinal Diseases - drug therapy
Gastrointestinal Diseases - epidemiology
Helicobacter pylori
Humans
Internal Medicine
Kaplan-Meier Estimate
Medicine
Medicine & Public Health
Nonsteroidal anti-inflammatory drugs
Original Research Article
Pharmacology/Toxicology
Pharmacotherapy
Proton Pump Inhibitors - therapeutic use
Randomized Controlled Trials as Topic
Secondary Prevention
Stomach - microbiology
Treatment Outcome
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Summary:Background and Objective: Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of pain in rheumatic disorders and chronic pain syndromes. Their use is, however, limited by gastrointestinal (GI) toxicity, including upper GI symptoms, ulcers and related complications. Using data from the NASA/SPACE studies, we have reviewed the efficacy and tolerability of esomeprazole (20 or 40 mg once daily) in the management (i.e. short-term resolution plus long-term prevention of relapse) of upper GI symptoms in users of continuous daily NSAIDs. Methods: The NASA/SPACE programme comprised four double-blind, placebo-controlled studies in NSAID users. Two studies evaluated the efficacy of esomeprazole for upper GI symptom relief over 4 weeks. Those patients with symptom relief were then enrolled into a further two studies that assessed efficacy over 6 months. Results: In the 4-week studies, more patients in the esomeprazole groups achieved relief from upper GI symptoms at week 4 compared with placebo (p
ISSN:1173-2563
1179-1918
DOI:10.2165/11317830-000000000-00000