Comparison of esomeprazole enteric-coated capsules vs esomeprazole magnesium in the treatment of active duodenal ulcer： A randomized, double-blind, controlled study

• Published in: World journal of gastroenterology : WJG Vol. 14; no. 12; pp. 1941 - 1945
• Main Authors: Liang, Xiao-Yan, Gao, Qing, Gong, Neng-Ping, Tang, Li-Ping, Wang, Pi-Long, Tao, Xiao-Hong
• Format: Journal Article
• Language: English
• Published: United States Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China 28.03.2008; The WJG Press and Baishideng
• Subjects: Adolescent; Adult; Aged; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - therapeutic use; Dosage Forms; Double-Blind Method; Duodenal Ulcer - drug therapy; Duodenal Ulcer - pathology; Esomeprazole - administration & dosage; Esomeprazole - therapeutic use; Female; Humans; Male; Middle Aged; Rapid Communication; Treatment Outcome; 十二指肠溃疡; 肠表面; 药物治疗; Duodenal ulcer; Esomeprazole; Proton pump inhibitor
• ISSN: 1007-9327; 2219-2840
• DOI: 10.3748/wjg.14.1941

AIM： To evaluate the efficacy and tolerability of two different preparations of esomeprazole in healing duodenal ulcers. METHODS： A total of 60 patients with active duodenal ulcers were enrolled and randomized to receive esomeprazole enteric-coated capsules （40 mg） or esomeprazole magnesium （40 mg）, once daily, for 4 consecutive wk, with ulcer healing being monitored by endoscopy. Safety and tolerability were also assessed. RESULTS： Fifty seven patients completed the whole trial. The ulcer healing rates at the end of wk 2 were 86.7% and 85.2% in the esomeprazole enteric-coated capsules and esomeprazole magnesium groups, respectively （P = 0.8410）, and reached 100% at the end of wk 4 in beth groups. Symptom relief at the end of wk 2 was 90.8% in the esomeprazole enteric-coated capsules group and 86.7% in the esomeprazole magnesium group （P = 0.5406）; at the end of wk 4 symptom relief was 95.2% and 93.2%, respectively （P = 0.5786）. Adverse events occurred in 16.7% of the esomeprazole entericcoated capsules group and 14.8% of the esomeprazole magnesium group （P = 1.0000）. CONCLUSION： The efficacies of esomeprazole entericcoated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of beth drugs were comparable.