| Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: results of a randomized double-blind trial. | |
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MedLine Citation:
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PMID: 15480981 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Gastroenterology Volume: 127 ISSN: 0016-5085 ISO Abbreviation: Gastroenterology Publication Date: 2004 Oct |
Date Detail:
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Created Date: 2004-10-13 Completed Date: 2004-11-03 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0374630 Medline TA: Gastroenterology Country: United States |
Other Details:
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Languages: eng Pagination: 1038-43 Citation Subset: AIM; IM |
Affiliation:
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Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR. fklchan@cuhk.edu.hk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Arthritis / drug therapy* Diclofenac / administration & dosage*, adverse effects Double-Blind Method Drug Therapy, Combination Dyspepsia / chemically induced Female Humans Male Middle Aged Omeprazole / administration & dosage*, adverse effects Peptic Ulcer / chemically induced, prevention & control Prospective Studies Pyrazoles Recurrence Sulfonamides / adverse effects, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Pyrazoles; 0/Sulfonamides; 15307-86-5/Diclofenac; 169590-42-5/celecoxib; 73590-58-6/Omeprazole |
| Comments/Corrections | |
Comment In:
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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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