Document Detail

Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: results of a randomized double-blind trial.
MedLine Citation:
PMID:  15480981     Owner:  NLM     Status:  MEDLINE    
BACKGROUND & AIMS: The gastric safety of cyclooxgenase-2 inhibitors and prophylactic antisecretory therapy in high-risk arthritis patients is unclear. We studied the ulcer incidence and factors predicting ulcer recurrence in a prospective, double-blinded trial. METHODS: We studied patients who presented with nonsteroidal anti-inflammatory drug-associated ulcer bleeding. After ulcer healing, patients who were negative for Helicobacter pylori were randomly assigned to celecoxib 200 mg twice a day plus omeprazole placebo once daily or diclofenac 75 mg twice daily plus omeprazole 20 mg once daily for 6 months. Patients underwent endoscopy if they developed recurrent bleeding. Those without recurrent events underwent endoscopy at their last follow-up visit. RESULTS: Two hundred eighty-seven patients were enrolled; 24 had recurrent gastrointestinal complications. Among 259 patients without events, 222 underwent endoscopy (116 received celecoxib and 106 received diclofenac plus omeprazole). The probability of recurrent ulcers in 6 months was 18.7% in the celecoxib group and 25.6% in the diclofenac plus omeprazole group (difference, -6.7%; 95% CI: -17.8% to 3.9%) (P = 0.21). Combining bleeding and endoscopic ulcers, 24.1% in the celecoxib group and 32.3% in the diclofenac plus omeprazole group had recurrent ulcers in 6 months (difference, -8.2%; 95% CI: -19.5% to 2.9%) (P = 0.15). Treatment-induced significant dyspepsia (hazard ratio, 5.3; 95% CI: 2.6-10.8), age > or =75 (hazard ratio, 2.0; 95% CI: 1.1-3.5), and comorbidity (hazard ratio, 2.1; 95% CI: 1.2-3.7) independently predicted ulcer recurrence. CONCLUSIONS: Among patients with previous ulcer bleeding, neither celecoxib nor diclofenac plus omeprazole adequately prevents ulcer recurrence. Treatment-induced significant dyspepsia is an indication for endoscopic evaluation.
Francis K L Chan; Lawrence C T Hung; Bing Y Suen; Vincent W S Wong; Aric J Hui; Justin C Y Wu; Wai K Leung; Yuk T Lee; Ka F To; S C Sydney Chung; Joseph J Y Sung
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Gastroenterology     Volume:  127     ISSN:  0016-5085     ISO Abbreviation:  Gastroenterology     Publication Date:  2004 Oct 
Date Detail:
Created Date:  2004-10-13     Completed Date:  2004-11-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1038-43     Citation Subset:  AIM; IM    
Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
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MeSH Terms
Arthritis / drug therapy*
Diclofenac / administration & dosage*,  adverse effects
Double-Blind Method
Drug Therapy, Combination
Dyspepsia / chemically induced
Middle Aged
Omeprazole / administration & dosage*,  adverse effects
Peptic Ulcer / chemically induced,  prevention & control
Prospective Studies
Sulfonamides / adverse effects,  therapeutic use*
Reg. No./Substance:
0/Pyrazoles; 0/Sulfonamides; 15307-86-5/Diclofenac; 169590-42-5/celecoxib; 73590-58-6/Omeprazole
Comment In:
ACP J Club. 2005 May-Jun;142(3):76   [PMID:  15862075 ]
Gastroenterology. 2004 Oct;127(4):1256-8   [PMID:  15481002 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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