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.
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<0.05). The proportion of patients with symptom relapse at 6 months was lower with esomeprazole 20 mg and 40 mg than with placebo (p<or=0.01).


CONCLUSIONS
Esomeprazole proved effective for both short-term resolution of, and sustained relief from, upper GI symptoms in long-term NSAID users, and was well tolerated.
Hawkey
Christopher J
CJ
Institute of Clinical Research, Wolfson Digestive Diseases Centre, University Hospital, Nottingham, UK. cj.hawkey@nottingham.ac.uk
Svedberg
Lars-Erik
LE
Naesdal
Jørgen
J
Byrne
Claire
C
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064098:Esomeprazole / Q000627:therapeutic use*; D005744:Gastric Acid / Q000378:metabolism; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori; D006801:Humans; D053208:Kaplan-Meier Estimate; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D055502:Secondary Prevention; D013270:Stomach / Q000382:microbiology; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D054328:Proton Pump Inhibitors; D064098:Esomeprazole