Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study.
The effectiveness of low-dose omeprazole as primary prevention of gastrointestinal adverse events due to episodic use of non-selective NSAIDs was evaluated. Healthy adults aged 50-75 who did not take chronic NSAIDs were randomized to a 6.5-day treatment of naproxen 500 mg twice daily plus omeprazole 20 mg daily or naproxen 500 mg twice daily plus placebo. Seventy subjects were enrolled (mean age 58.6 years, proportion >60 = 41.4%). Subjects receiving naproxen plus omeprazole developed fewer gastroduodenal ulcers compared to subjects receiving naproxen plus placebo (11.8% vs. 46.9%, P = 0.002). Likewise, naproxen plus omeprazole was associated with a decreased risk of ulceration and/or >5 erosions (38.2% vs. 81.3%, P < or = 0.001), and a smaller change in dyspepsia score. Considering their relatively low cost, ready availability, and favorable safety profile, low-dose PPI co-prescription in healthy adults requiring short-term therapy with non-selective NSAIDs may be reasonable.
Desai
Jay C
JC
Department of Medicine (Gastroenterology), The Mount Sinai School of Medicine, New York, NY 10075-0903, USA.
Sanyal
Shefali M
SM
Goo
Tyralee
T
Benson
Ariel A
AA
Bodian
Carol A
CA
Miller
Kenneth M
KM
Cohen
Lawrence B
LB
Aisenberg
James
J
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced / Q000382:microbiology / Q000473:pathology / Q000517:prevention & control*; D004384:Duodenoscopy; D004415:Dyspepsia / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D005773:Gastroscopy; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects*; D009853:Omeprazole / Q000008:administration & dosage*; D010865:Pilot Projects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D012016:Reference Values; D013276:Stomach Ulcer / Q000139:chemically induced / Q000382:microbiology / Q000473:pathology / Q000517:prevention & control*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D054328:Proton Pump Inhibitors; D009288:Naproxen; D009853:Omeprazole