Comparison of esomeprazole enteric-coated capsules vs esomeprazole magnesium in the treatment of active duodenal ulcer: a randomized, double-blind, controlled study.
OBJECTIVE
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 both 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 enteric-coated capsules group and 14.8% of the esomeprazole magnesium group (P = 1.0000).


CONCLUSIONS
The efficacies of esomeprazole enteric-coated capsules and esomeprazole magnesium in healing duodenal ulcer lesions and relieving gastrointestinal symptoms are equivalent. The tolerability and safety of both drugs were comparable.
Liang
Xiao-Yan
XY
Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China. lxyan925@yahoo.com.cn
Gao
Qing
Q
Gong
Neng-Ping
NP
Tang
Li-Ping
LP
Wang
Pi-Long
PL
Tao
Xiao-Hong
XH
D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004304:Dosage Forms; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000473:pathology; D064098:Esomeprazole / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D004304:Dosage Forms; D064098:Esomeprazole