title: Healing of gastric ulcers with esomeprazole versus ranitidine in patients who continued to receive NSAID therapy: a randomized trial.
abstract: OBJECTIVE
  To compare orally administered esomeprazole 40 mg once daily and 20 mg once daily with ranitidine 150 mg twice daily for the healing of gastric ulcers (GUs) during 8 wks in patients who continued to receive daily nonsteroidal anti-inflammatory drug (NSAID) therapy.
  
  
  METHODS
  This multicenter, randomized, double-blind, parallel-group trial included patients who were receiving nonselective or cyclo-oxygenase-2 (COX-2)-selective NSAIDs and had at least one GU >or=5 mm but no gastric or duodenal ulcer >25 mm in diameter at the baseline esophagogastroduodenoscopy (EGD). After 4 and 8 wks of treatment, ulcer-healing status was confirmed by EGD. The primary outcome was the percentage of patients in each treatment group who had no GUs (GU healing rate) at week 8.
  
  
  RESULTS
  A total of 406 patients were randomized to treatment. At week 8, GU healing rates with esomeprazole 40 and 20 mg were 91.5% (118/129; 95% CI, 86.7-96.3%) and 88.4% (122/138; 95% CI, 83.1-93.7%), respectively, and were significantly higher than the 74.2% rate (98/132; 95% CI, 66.8-81.7%) with ranitidine (p<0.01 for both comparisons). GU healing rates at 4 wks (78.3%[101/129] and 79.0%[109/138] in the esomeprazole 40- and 20-mg groups, respectively) were also significantly higher (p<0.05) than in the ranitidine group (66.7%[88/132]). All treatments were well tolerated.
  
  
  CONCLUSIONS
  Esomeprazole 40 and 20 mg once daily are effective and well-tolerated therapies compared with ranitidine 150 mg twice daily for healing GUs in patients who need to continue NSAID therapy.
authors.affiliation: University of Illinois at Chicago, Chicago, Illinois 60612, USA.
authors.forename: Jay L
authors.initials: JL
authors.lastname: Goldstein
authors.forename: John F
authors.initials: JF
authors.lastname: Johanson
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Suchower
authors.forename: Kurt A
authors.initials: KA
authors.lastname: Brown
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000187:drug effects / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011899:Ranitidine / Q000008:administration & dosage*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D013276:Stomach Ulcer / Q000139:chemically induced* / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D011899:Ranitidine; D064098:Esomeprazole