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- Publisher Website: 10.1053/j.gastro.2004.07.010
- Scopus: eid_2-s2.0-5144227526
- PMID: 15480981
- WOS: WOS:000224604400008
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Article: Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial
Title | Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial |
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Authors | |
Issue Date | 2004 |
Publisher | WB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro |
Citation | Gastroenterology, 2004, v. 127 n. 4, p. 1038-1043 How to Cite? |
Abstract | 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 ≥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. |
Persistent Identifier | http://hdl.handle.net/10722/163201 |
ISSN | 2023 Impact Factor: 25.7 2023 SCImago Journal Rankings: 7.362 |
ISI Accession Number ID | |
References |
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Chan, FKL | en_US |
dc.contributor.author | Hung, LCT | en_US |
dc.contributor.author | Suen, BY | en_US |
dc.contributor.author | Wong, VWS | en_US |
dc.contributor.author | Hui, AJ | en_US |
dc.contributor.author | Wu, JCY | en_US |
dc.contributor.author | Leung, WK | en_US |
dc.contributor.author | Lee, YT | en_US |
dc.contributor.author | To, KF | en_US |
dc.contributor.author | Chung, SCS | en_US |
dc.contributor.author | Sung, JJY | en_US |
dc.date.accessioned | 2012-09-05T05:28:41Z | - |
dc.date.available | 2012-09-05T05:28:41Z | - |
dc.date.issued | 2004 | en_US |
dc.identifier.citation | Gastroenterology, 2004, v. 127 n. 4, p. 1038-1043 | en_US |
dc.identifier.issn | 0016-5085 | en_US |
dc.identifier.uri | http://hdl.handle.net/10722/163201 | - |
dc.description.abstract | 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 ≥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. | en_US |
dc.language | eng | en_US |
dc.publisher | WB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastro | en_US |
dc.relation.ispartof | Gastroenterology | en_US |
dc.subject.mesh | Adult | en_US |
dc.subject.mesh | Aged | en_US |
dc.subject.mesh | Arthritis - Drug Therapy | en_US |
dc.subject.mesh | Diclofenac - Administration & Dosage - Adverse Effects | en_US |
dc.subject.mesh | Double-Blind Method | en_US |
dc.subject.mesh | Drug Therapy, Combination | en_US |
dc.subject.mesh | Dyspepsia - Chemically Induced | en_US |
dc.subject.mesh | Female | en_US |
dc.subject.mesh | Humans | en_US |
dc.subject.mesh | Male | en_US |
dc.subject.mesh | Middle Aged | en_US |
dc.subject.mesh | Omeprazole - Administration & Dosage - Adverse Effects | en_US |
dc.subject.mesh | Peptic Ulcer - Chemically Induced - Prevention & Control | en_US |
dc.subject.mesh | Prospective Studies | en_US |
dc.subject.mesh | Pyrazoles | en_US |
dc.subject.mesh | Recurrence | en_US |
dc.subject.mesh | Sulfonamides - Adverse Effects - Therapeutic Use | en_US |
dc.title | Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial | en_US |
dc.type | Article | en_US |
dc.identifier.email | Leung, WK:waikleung@hku.hk | en_US |
dc.identifier.authority | Leung, WK=rp01479 | en_US |
dc.description.nature | link_to_subscribed_fulltext | en_US |
dc.identifier.doi | 10.1053/j.gastro.2004.07.010 | en_US |
dc.identifier.pmid | 15480981 | en_US |
dc.identifier.scopus | eid_2-s2.0-5144227526 | en_US |
dc.relation.references | http://www.scopus.com/mlt/select.url?eid=2-s2.0-5144227526&selection=ref&src=s&origin=recordpage | en_US |
dc.identifier.volume | 127 | en_US |
dc.identifier.issue | 4 | en_US |
dc.identifier.spage | 1038 | en_US |
dc.identifier.epage | 1043 | en_US |
dc.identifier.isi | WOS:000224604400008 | - |
dc.publisher.place | United States | en_US |
dc.identifier.scopusauthorid | Chan, FKL=7202586434 | en_US |
dc.identifier.scopusauthorid | Hung, LCT=7103351774 | en_US |
dc.identifier.scopusauthorid | Suen, BY=6506058430 | en_US |
dc.identifier.scopusauthorid | Wong, VWS=7202525502 | en_US |
dc.identifier.scopusauthorid | Hui, AJ=7102453674 | en_US |
dc.identifier.scopusauthorid | Wu, JCY=7409253910 | en_US |
dc.identifier.scopusauthorid | Leung, WK=7201504523 | en_US |
dc.identifier.scopusauthorid | Lee, YT=36340251700 | en_US |
dc.identifier.scopusauthorid | To, KF=7101911940 | en_US |
dc.identifier.scopusauthorid | Chung, SCS=19642462800 | en_US |
dc.identifier.scopusauthorid | Sung, JJY=35405352400 | en_US |
dc.identifier.issnl | 0016-5085 | - |