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Article: Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial

TitleCombination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
Authors
Issue Date2007
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
Citation
Lancet, 2007, v. 369 n. 9573, p. 1621-1626 How to Cite?
AbstractBackground: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4-13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. © 2007 Elsevier Ltd. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/163078
ISSN
2023 Impact Factor: 98.4
2023 SCImago Journal Rankings: 12.113
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorChan, FKLen_US
dc.contributor.authorWong, VWSen_US
dc.contributor.authorSuen, BYen_US
dc.contributor.authorWu, JCYen_US
dc.contributor.authorChing, JYLen_US
dc.contributor.authorHung, LCTen_US
dc.contributor.authorHui, AJen_US
dc.contributor.authorLeung, VKSen_US
dc.contributor.authorLee, VWYen_US
dc.contributor.authorLai, LHen_US
dc.contributor.authorWong, GLHen_US
dc.contributor.authorChow, DKLen_US
dc.contributor.authorTo, KFen_US
dc.contributor.authorLeung, WKen_US
dc.contributor.authorChiu, PWYen_US
dc.contributor.authorLee, YTen_US
dc.contributor.authorLau, JYWen_US
dc.contributor.authorChan, HLYen_US
dc.contributor.authorNg, EKWen_US
dc.contributor.authorSung, JJYen_US
dc.date.accessioned2012-09-05T05:27:19Z-
dc.date.available2012-09-05T05:27:19Z-
dc.date.issued2007en_US
dc.identifier.citationLancet, 2007, v. 369 n. 9573, p. 1621-1626en_US
dc.identifier.issn0140-6736en_US
dc.identifier.urihttp://hdl.handle.net/10722/163078-
dc.description.abstractBackground: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4-13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. © 2007 Elsevier Ltd. All rights reserved.en_US
dc.languageengen_US
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lanceten_US
dc.relation.ispartofLanceten_US
dc.subject.meshAgeden_US
dc.subject.meshAnti-Inflammatory Agents, Non-Steroidal - Adverse Effects - Therapeutic Useen_US
dc.subject.meshAnti-Ulcer Agents - Adverse Effects - Therapeutic Useen_US
dc.subject.meshCyclooxygenase Inhibitors - Adverse Effects - Therapeutic Useen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshDrug Therapy, Combinationen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshOmeprazole - Adverse Effects - Therapeutic Useen_US
dc.subject.meshOsteoarthritis - Drug Therapyen_US
dc.subject.meshPeptic Ulcer Hemorrhage - Chemically Induced - Prevention & Control - Therapyen_US
dc.subject.meshProton Pumps - Antagonists & Inhibitorsen_US
dc.subject.meshPyrazoles - Adverse Effects - Therapeutic Useen_US
dc.subject.meshRecurrence - Prevention & Controlen_US
dc.subject.meshRisk Factorsen_US
dc.subject.meshSulfonamides - Adverse Effects - Therapeutic Useen_US
dc.subject.meshTreatment Outcomeen_US
dc.titleCombination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised 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.doi10.1016/S0140-6736(07)60749-1en_US
dc.identifier.pmid17499604en_US
dc.identifier.scopuseid_2-s2.0-34248216918en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-34248216918&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume369en_US
dc.identifier.issue9573en_US
dc.identifier.spage1621en_US
dc.identifier.epage1626en_US
dc.identifier.isiWOS:000246488800031-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridChan, FKL=7202586434en_US
dc.identifier.scopusauthoridWong, VWS=7202525502en_US
dc.identifier.scopusauthoridSuen, BY=6506058430en_US
dc.identifier.scopusauthoridWu, JCY=7409260329en_US
dc.identifier.scopusauthoridChing, JYL=7005086238en_US
dc.identifier.scopusauthoridHung, LCT=7103351774en_US
dc.identifier.scopusauthoridHui, AJ=7102453674en_US
dc.identifier.scopusauthoridLeung, VKS=7102336049en_US
dc.identifier.scopusauthoridLee, VWY=7402507380en_US
dc.identifier.scopusauthoridLai, LH=12759998700en_US
dc.identifier.scopusauthoridWong, GLH=9248570900en_US
dc.identifier.scopusauthoridChow, DKL=12760026500en_US
dc.identifier.scopusauthoridTo, KF=55245402900en_US
dc.identifier.scopusauthoridLeung, WK=7201504523en_US
dc.identifier.scopusauthoridChiu, PWY=7103182534en_US
dc.identifier.scopusauthoridLee, YT=8041471500en_US
dc.identifier.scopusauthoridLau, JYW=13907867100en_US
dc.identifier.scopusauthoridChan, HLY=16038785900en_US
dc.identifier.scopusauthoridNg, EKW=7201647539en_US
dc.identifier.scopusauthoridSung, JJY=35405352400en_US
dc.identifier.issnl0140-6736-

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