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

• Published in: Digestive diseases and sciences 2008-08, Vol.53 (8), p.2059-2065
• Main Authors: Desai, Jay C., Sanyal, Shefali M., Goo, Tyralee, Benson, Ariel A., Bodian, Carol A., Miller, Kenneth M., Cohen, Lawrence B., Aisenberg, James
• Format: Article
• Language: English
• Subjects: Aged; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Biochemistry; Biological and medical sciences; Digestive system; Double-Blind Method; Duodenal Ulcer - chemically induced; Duodenal Ulcer - microbiology; Duodenal Ulcer - pathology; Duodenal Ulcer - prevention & control; Duodenoscopy; Dyspepsia - chemically induced; Dyspepsia - prevention & control; Feeding. Feeding behavior; Female; Fundamental and applied biological sciences. Psychology; Gastroenterology; Gastroenterology. Liver. Pancreas. Abdomen; Gastroscopy; Helicobacter pylori - isolation & purification; Hepatology; Humans; Male; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Naproxen - adverse effects; Omeprazole - administration & dosage; Oncology; Original Paper; Other diseases. Semiology; Pharmacology. Drug treatments; Pilot Projects; Proton Pump Inhibitors - administration & dosage; Reference Values; Stomach Ulcer - chemically induced; Stomach Ulcer - microbiology; Stomach Ulcer - pathology; Stomach Ulcer - prevention & control; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Transplant Surgery; Treatment Outcome; Vertebrates: anatomy and physiology, studies on body, several organs or systems
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-007-0127-4

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  ≤ 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.