Incidence of gastroduodenal ulcers associated with valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis

Sikes, David; Agrawal, Naurang M.; Zhao, Wen; Kent, Jeffrey D.; Recker, David P.; Verburg, Kenneth M.

doi:10.1097/00042737-200210000-00011

Cited by 101 publications

(77 citation statements)

References 46 publications

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“…Valdecoxib and other COX-2 specific inhibitors have demonstrated improved GI safety profiles compared with nonspecific NSAIDs due to their COX-1-sparing effects. 11,17,18 Naproxen was chosen as the comparator in this study for several reasons. A 550-mg dose of naproxen sodium twice daily is indicated for treatment of primary dysmenorrhea, as is valdecoxib 20 mg twice daily (or 40 mg daily), and the duration of effect for naproxen is similar to the duration of effect for valdecoxib.…”

Section: Discussionmentioning

confidence: 99%

“…10 Compared with nonspecific NSAIDs in controlled trials, valdecoxib exhibits improved GI and platelet safety. 11,12 This study compared the analgesic efficacy of valdecoxib 20 mg or 40 mg with naproxen sodium and placebo in relieving moderate or severe menstrual cramping pain due to primary dysmenorrhea. Up to 2 doses could be taken daily, as required, for up to 3 days.…”

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Valdecoxib for treatment of primary dysmenorrhea

2005

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OBJECTIVE:To compare the analgesic efficacy of valdecoxib with placebo and naproxen sodium for relieving menstrual cramping and pain due to primary dysmenorrhea. DESIGN:Single-center, double-blind study with a 4-period, 4-sequence crossover design. Patients assessed pain intensity and pain relief at regular intervals up to 12 hours following the initial dose.SETTING: Privately owned outpatient clinic. PATIENTS/PARTICIPANTS:One hundred twenty patients with moderate to severe menstrual cramping were randomized. Eighty-seven patients completed all treatment cycles. INTERVENTIONS:Valdecoxib 20 mg or 40 mg, naproxen sodium 550 mg, or placebo twice a day as required for 3 days in a single menstrual cycle. MEASUREMENTS AND MAIN RESULTS:Both doses of valdecoxib (20 and 40 mg) were comparable to naproxen sodium and superior to placebo at all time points assessed for each of the primary end points. Valdecoxib and naproxen sodium had comparable onset and duration of action. Although the study design allowed patients 2 doses per day, only 15% and 20% of patients in the valdecoxib 20 mg and valdecoxib 40 mg groups, respectively, required remedication within the first 12 hours. The incidence of adverse events was similar between active and placebo groups. CONCLUSION:Valdecoxib provided a fast onset of analgesic action, a level of efficacy similar to naproxen sodium, and a high level of patient satisfaction in the relief of menstrual pain due to primary dysmenorrhea. Valdecoxib was effective and well tolerated and thus appears to be a viable treatment for menstrual pain due to primary dysmenorrhea.KEY WORDS: valdecoxib; naproxen sodium; primary dysmenorrhea; menstrual pain. DOI: 10.1111/j. 1525-1497.2004.30052.x J GEN INTERN MED 2004 20:62-67. P rimary dysmenorrhea, or painful menstruation, can be an incapacitating problem, causing significant disruption in a woman's life each month. It is one of the most common gynecologic complaints, thought to affect approximately one half of all menstruating women, with 10% of women having symptoms severe enough to interfere with daily responsibilities. 1The underlying cause of primary dysmenorrhea is believed to be the excessive production of uterine prostaglandins primarily derived from cyclooxygenase (COX)-2 activity.2 Inhibition of COX-2 by nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen exerts anti-inflammatory, antipyretic, and analgesic effects. However, nonspecific NSAIDs also inhibit COX-1 at therapeutic doses, the latter activity impairing platelet function and predisposing patients to gastrointestinal (GI) side effects.3,4COX-2 specific inhibitors produce the analgesic and antiinflammatory effects of nonspecific NSAIDs without COX-1-associated side effects and are effective in treating pain, including menstrual pain.3,5-8Valdecoxib, a potent COX-2 specific inhibitor, is approximately 28,000-fold more selective in vitro for human recombinant COX-2 than for human recombinant COX-1.9 When administered after oral surgery, valdecoxib...

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Valdecoxib for treatment of primary dysmenorrhea

2005

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“…Sikes and colleagues 261 and Pfizer Study 047 263 provided numerical data. Pooled results from these two trials are summarised in Table 43.…”

Section: Subgroup Analysesmentioning

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

266

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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“…[25][26][27][28][29][30] However, a meta-analysis of 8000 patients from 10 randomized OA and RA trials did not reveal any significant increase in the incidence of cardiovascular events (cardiac, cerebrovascular and peripheral vascular, arterial thrombotic) in patients taking valdecoxib (10-80 mg daily) as compared with patients taking a traditional NSAID (diclofenac sodium 75 mg twice daily, ibuprofen 800 mg three times daily, or naproxen 500 mg twice daily). 31 Furthermore, the risk of serious thrombotic events was also similar for each valdecoxib dosage.…”

Section: Cardiovascular Safety Of Cox-2-selective Nsaidsmentioning

confidence: 99%

Risks versus benefits of cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs

Chaiamnuay

Allison²,

Curtis³

2006

American Journal of Health-System Pharmacy

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PURPOSE: A summary of the basic science underlying the current controversies regarding cyclooxygenase-2 (COX-2)-selective nonsteroidal antiinflammatory drugs (NSAIDs), including data on their cardiovascular safety, their gastrointestinal (GI) benefits, cost-effectiveness, physician-prescribing trends, and recommendations for prescribing these agents is presented. SUMMARY: A number of randomized controlled trials (RCTs) have reported that COX-2-selective NSAIDs increase cardiovascular events, although there appear to be gradations of risks among the COX-2-selective NSAIDs. In addition, traditional NSAIDs may increase the risk for cardiovascular events, complicating the interpretation of RCTs that use traditional NSAIDs as comparators. Selective inhibitors of COX-2-selective NSAIDs are effective antiinflammatory and analgesic drugs with improved upper-GI safety compared to traditional NSAIDs. Data on the cost-effectiveness of COX-2-selective NSAIDs indicate that they should be limited to patients at high risk for upper-GI adverse effects. However, they had been increasingly used in patients with lower GI risks until recent events reversed that trend. Circumstances under which COX-2-selective NSAIDs may be appropriate are in patients at high GI risk and in patients who did not respond to multiple traditional NSAIDs. The national spotlight in the United States on NSAID-related adverse events and recent lawsuits against health care providers prescribing COX-2-selective NSAIDs further highlights the need for provider-patient communication and risk disclosure. The relative cardiovascular risks of NSAIDs are similar in magnitude to other currently prescribed therapies. CONCLUSION: Health care providers must consider the efficacy, GI and cardiovascular risks, concomitant medications, and costs when determining the appropriateness of COX-2-selective NSAID therapy

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Incidence of gastroduodenal ulcers associated with valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis

Cited by 101 publications

References 46 publications

Valdecoxib for treatment of primary dysmenorrhea

Valdecoxib for treatment of primary dysmenorrhea

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

Risks versus benefits of cyclooxygenase-2-selective nonsteroidal antiinflammatory drugs

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