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Article: Celecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial

TitleCelecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trial
Authors
Issue Date2004
PublisherWB 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?
AbstractBackground & 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 Identifierhttp://hdl.handle.net/10722/163201
ISSN
2015 Impact Factor: 18.187
2015 SCImago Journal Rankings: 7.170
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorChan, FKLen_US
dc.contributor.authorHung, LCTen_US
dc.contributor.authorSuen, BYen_US
dc.contributor.authorWong, VWSen_US
dc.contributor.authorHui, AJen_US
dc.contributor.authorWu, JCYen_US
dc.contributor.authorLeung, WKen_US
dc.contributor.authorLee, YTen_US
dc.contributor.authorTo, KFen_US
dc.contributor.authorChung, SCSen_US
dc.contributor.authorSung, JJYen_US
dc.date.accessioned2012-09-05T05:28:41Z-
dc.date.available2012-09-05T05:28:41Z-
dc.date.issued2004en_US
dc.identifier.citationGastroenterology, 2004, v. 127 n. 4, p. 1038-1043en_US
dc.identifier.issn0016-5085en_US
dc.identifier.urihttp://hdl.handle.net/10722/163201-
dc.description.abstractBackground & 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.languageengen_US
dc.publisherWB Saunders Co. The Journal's web site is located at http://www.elsevier.com/locate/gastroen_US
dc.relation.ispartofGastroenterologyen_US
dc.subject.meshAdulten_US
dc.subject.meshAgeden_US
dc.subject.meshArthritis - Drug Therapyen_US
dc.subject.meshDiclofenac - Administration & Dosage - Adverse Effectsen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshDrug Therapy, Combinationen_US
dc.subject.meshDyspepsia - Chemically Induceden_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshOmeprazole - Administration & Dosage - Adverse Effectsen_US
dc.subject.meshPeptic Ulcer - Chemically Induced - Prevention & Controlen_US
dc.subject.meshProspective Studiesen_US
dc.subject.meshPyrazolesen_US
dc.subject.meshRecurrenceen_US
dc.subject.meshSulfonamides - Adverse Effects - Therapeutic Useen_US
dc.titleCelecoxib versus diclofenac plus omeprazole in high-risk arthritis patients: Results of a randomized double-blind trialen_US
dc.typeArticleen_US
dc.identifier.emailLeung, WK:waikleung@hku.hken_US
dc.identifier.authorityLeung, WK=rp01479en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1053/j.gastro.2004.07.010en_US
dc.identifier.pmid15480981en_US
dc.identifier.scopuseid_2-s2.0-5144227526en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-5144227526&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume127en_US
dc.identifier.issue4en_US
dc.identifier.spage1038en_US
dc.identifier.epage1043en_US
dc.identifier.isiWOS:000224604400008-
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridChan, FKL=7202586434en_US
dc.identifier.scopusauthoridHung, LCT=7103351774en_US
dc.identifier.scopusauthoridSuen, BY=6506058430en_US
dc.identifier.scopusauthoridWong, VWS=7202525502en_US
dc.identifier.scopusauthoridHui, AJ=7102453674en_US
dc.identifier.scopusauthoridWu, JCY=7409253910en_US
dc.identifier.scopusauthoridLeung, WK=7201504523en_US
dc.identifier.scopusauthoridLee, YT=36340251700en_US
dc.identifier.scopusauthoridTo, KF=7101911940en_US
dc.identifier.scopusauthoridChung, SCS=19642462800en_US
dc.identifier.scopusauthoridSung, JJY=35405352400en_US

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