Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis

Laine, Loren; Bombardier, Claire; Hawkey, Christopher J.; Davis, Barry R.; Shapiro, Deborah R.; Brett, C.; Reicin, Alise

doi:10.1053/gast.2002.36013

Cited by 233 publications

(131 citation statements)

References 20 publications

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“…60 Post hoc analysis of the Vioxx Gastrointestinal Outcomes Research (VIGOR) and CLASS studies, in which COX-2 selective NSAIDs were compared with other NSAIDs and evidence of H. pylori infection was sought, shows no clear relationship between signs of infection and ulcer complications. 44,63 …”

Section: Helicobacter Pylori and Nsaidsmentioning

confidence: 99%

Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation

Chen

Jobanputra²,

Barton³

et al. 2008

Health Technol Assess

271

174

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Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. NHS libraries can subscribe free of charge. Public libraries can subscribe at a very reduced cost of £100 for each volume (normally comprising 30-40 titles). The commercial subscription rate is £300 per volume. Please see our website for details. Subscriptions can only be purchased for the current or forthcoming volume. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK. We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA Programme and lists the membership of the various committees. Declared competing interests of authors: P Jobanputra has received funding from Pfizer for two research studies: 'quality of care in patients with musculoskeletal pain who use NSAIDs' and 'perception of risk in relation to NSAID use for patients with RA and OA'. He has also been entertained, paid to speak and provided with financial assistance for educational purposes by many manufacturers of non-steroidal anti-inflammatory drugs, new and old. RS Taylor has undertaken paid presentations for Pfizer (Canada) and Novartis (UK) not related to rheumatoid arthritis or osteoarthritis management. HTA Published April 2008This report should be referenced as follows:Chen Y-F, Jobanputra P, Barton P, Bryan S, Fry-Smith A, Harris G, et al. Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) NIHR Health Technology Assessment ProgrammeT he Health Technology Assessment (HTA) Programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in th...

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Section: Helicobacter Pylori and Nsaidsmentioning

confidence: 99%

Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation

Chen

Jobanputra²,

Barton³

et al. 2008

Health Technol Assess

271

174

View full text Add to dashboard Cite

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“…In particular, the risk of developing NSAID-related GI complications is highest among patients taking concurrent aspirin, coumadin, or steroids; patients with a previous history of an ulcer hemorrhage; and patients Ͼ65 years of age (5,6). Moreover, the prevalence of these risk groups has increased significantly in lockstep with the aging of the American population and the increasing use of aspirin for cardioprophylaxis.…”

Section: Introductionmentioning

confidence: 99%

Minimizing complications from nonsteroidal antiinflammatory drugs: Cost‐effectiveness of competing strategies in varying risk groups

Spiegel¹,

Chiou²,

Ofman³

2005

Arthritis & Rheumatism

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Objective. To appraise the cost-effectiveness of competing therapeutic strategies in patient cohorts eligible for aspirin prophylaxis with varying degrees of gastrointestinal (GI) and cardiovascular risk. Methods. Cost-effectiveness and cost-utility analyses were performed to evaluate 3 competing strategies for the management of chronic arthritis: 1) a generic nonselective nonsteroidal antiinflammatory drug (NSAID NS ) alone; 2) NSAID NS plus a proton pump inhibitor (PPI); and 3) a cyclooxygenase 2-selective inhibitor (coxib) alone. Cost estimates were from a third-party payer perspective. The outcomes were incremental cost per ulcer complication avoided and incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was performed to evaluate the impact of varying patient GI risks and aspirin use. Results. In average-risk patients, the NSAID NS ؉ PPI strategy costs an incremental $45,350 per additional ulcer complication avoided and $309,666 per QALY gained compared with the NSAID NS strategy. The coxib strategy was less effective and more expensive than the NSAID NS ؉ PPI strategy. Sensitivity analysis revealed that the NSAID NS ؉ PPI strategy became the dominant approach in patients at high risk for an NSAID adverse event (i.e., patients taking aspirin with >1 risk factor for a GI complication). Conclusion. Generic nonselective NSAIDs are most cost-effective in patients at low risk for an adverse event. However, the addition of a PPI to a nonselective NSAID may be the preferred strategy in patients taking aspirin or otherwise at high risk for a GI or cardiovascular adverse event.

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“…A major concern with the use of COX inhibitors is the increased frequency of gastric ulcers, which can result in gastrointestinal bleeding severe enough to require hospitalization (17)(18)(19)(20)(21)(22)(23)(24). We therefore chose a preparation of a pan COX inhibitor, ketorolac tromethamine that was formulated as a rinse to reduce the risk of gastrointestinal bleeding (25)(26)(27).…”

Section: Introductionmentioning

confidence: 99%

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Mulshine¹,

Atkinson

Greer

et al. 2004

Clinical Cancer Research

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Purpose: Nonselective cyclooxygenase (COX) inhibitors have been reported to decrease the frequency of upper aerodigestive cancers. Ketorolac tromethamine oral rinse has been shown to resolve another COX-dependent process, periodontal disease, without incurring gastrointestinal side effects. This trial evaluated if a topically delivered oral rinse containing ketorolac was as safe as and more effective than oral rinse alone in reducing the area of oral leukoplakia.Experimental Design: 57 patients were randomized (2:1 ratio) in a double-blind, placebo-controlled study of ketorolac (10 ml of a 0.1% ketorolac rinse solution; n ‫؍‬ 38) or placebo (10 ml of rinse solution; n ‫؍‬ 19) given twice daily for 30 s over 90 days. Primary end point was evaluated visually obtaining bidimensional measurement of the size of leukoplakia lesion(s) at entry and at 90 days. Secondary end point was histological assessment of the leukoplakia as sampled by serial punch biopsy and independently reviewed by three pathologists.Results: The patients included 67% males, 11% nonCaucasian, and 86% used tobacco with no significant differences between the two arms. Both rinses were well tolerated with good compliance, and there was no significant difference in adverse events (P ‫؍‬ 0.27). Major response rate (complete response and partial response) was 30% for ketorolac and 32% for the placebo arm. There was no significant difference in change in histology between the two arms.Conclusion: Local delivery of a COX-containing oral rinse was well tolerated but produced no significant reduction in the extent of leukoplakia compared with the placebo. However, the favorable response rate to placebo arm remains unexplained and additional investigation of the tissue penetration with ketorolac is warranted.

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Stratifying the risk of NSAID-related upper gastrointestinal clinical events: Results of a double-blind outcomes study in patients with rheumatoid arthritis

Cited by 233 publications

References 20 publications

Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation

Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation

Minimizing complications from nonsteroidal antiinflammatory drugs: Cost‐effectiveness of competing strategies in varying risk groups

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

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