Rofecoxib, a New Cyclooxygenase 2 Inhibitor, Shows Sustained Efficacy, Comparable With Other Nonsteroidal Anti-inflammatory Drugs: A 6-Week and a 1-Year Trial in Patients With Osteoarthritis

Saag, Kenneth G.; D, van der Heijde; Fisher, Chester; Sâmara, Adil Muhib; DeTora, Lisa; Bolognese, James A.; Sperling, Rhoda; Daniels, Brian

doi:10.1001/archfami.9.10.1124

Cited by 103 publications

(54 citation statements)

References 13 publications

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“…One possible explanation for this observation could be the unrestricted use of up to 4,000 mg acetaminophen daily. Of note, the baseline WOMAC pain subscale scores (often the best predictor of a change) in this study were similar to those reported in other studies (26,27). The secondary efficacy measures (i.e., WOMAC subscale scores, rescue medication usage) supported the primary outcomes.…”

Section: Discussionsupporting

confidence: 87%

“…Additionally, these doses of AZD3582 were noninferior to rofecoxib 25 mg/day. The change in the WOMAC pain subscale score for placebo from baseline to the average of weeks 4 and 6 was larger in this study (LS mean decrease of 25 mm) than that inferred from other OA studies published recently (26,27). One possible explanation for this observation could be the unrestricted use of up to 4,000 mg acetaminophen daily.…”

Section: Discussioncontrasting

confidence: 68%

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Comparison of the COX‐inhibiting nitric oxide donator AZD3582 and rofecoxib in treating the signs and symptoms of Osteoarthritis of the knee

Schnitzer¹,

Kivitz²,

Lipetz³

et al. 2005

Arthritis & Rheumatism

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Objective. To compare the efficacy, safety, and tolerability of AZD3582 with that of rofecoxib, naproxen, and placebo in patients with osteoarthritis (OA) of the knee, and to define the dosage of AZD3582 (125 mg, 375 mg, and 750 mg twice a day) that is noninferior in efficacy to rofecoxib. Methods. A double-blind study of 672 patients with OA of the knee was conducted. Patients who experienced increased pain on withdrawal of analgesia were randomized to receive AZD3582 125 mg, 375 mg, or 750 mg twice a day; rofecoxib 25 mg once a day; naproxen 500 mg twice a day; or placebo for 6 weeks. Efficacy, tolerability, and safety were monitored throughout the study. The primary variable was the change in Western Ontario and McMaster Universities Osteoarthritis Index pain subscale from baseline to the mean of weeks 4 and 6, comparing AZD3582 with placebo for superiority and with rofecoxib for noninferiority using a predefined margin of 10 mm.

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Section: Discussionsupporting

confidence: 87%

Section: Discussioncontrasting

confidence: 68%

Comparison of the COX‐inhibiting nitric oxide donator AZD3582 and rofecoxib in treating the signs and symptoms of Osteoarthritis of the knee

Schnitzer¹,

Kivitz²,

Lipetz³

et al. 2005

Arthritis & Rheumatism

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show abstract

“…Doses of 12.5 and 25 mg of rofecoxib were found to provide optimal efficacy during 6 weeks of treatment (Ehrich et al, 1997 and to be more effective than placebo (Truitt et al, 1999;Day et al, 2000;Saag et al, 2000). In phase III clinical trials, treatment with rofecoxib (12.5 or 25 mg/ day) for 1 year was as effective as treatment with ibuprofen (800 mg t.i.d) or diclofenac (50 mg t.i.d.)…”

Section: A Treatment Of Inflammatory Diseasesmentioning

confidence: 99%

“…In phase III clinical trials, treatment with rofecoxib (12.5 or 25 mg/ day) for 1 year was as effective as treatment with ibuprofen (800 mg t.i.d) or diclofenac (50 mg t.i.d.) (Cannon et al, 2000;Saag et al, 2000).…”

Section: A Treatment Of Inflammatory Diseasesmentioning

confidence: 99%

Cyclooxygenase Isozymes: The Biology of Prostaglandin Synthesis and Inhibition

2004

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“…We identified 11 trials reporting dyspeptic symptoms in patients receiving coxibs versus NSAID NS (10,(35)(36)(37)(38)(39)(40)(41)(42)(43)(44). A previous meta-analysis of these trials calculated a pooled risk reduction of 23% for coxibs versus NSAID NS (12).…”

mentioning

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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Rofecoxib, a New Cyclooxygenase 2 Inhibitor, Shows Sustained Efficacy, Comparable With Other Nonsteroidal Anti-inflammatory Drugs: A 6-Week and a 1-Year Trial in Patients With Osteoarthritis

Abstract: Rofecoxib is effective in treating OA with once-daily dosing for 6 weeks and 1 year. Rofecoxib was generally safe and well-tolerated in OA patients for 6 weeks and 1 year. Arch Fam Med. 2000;9:1124-1134

Cited by 103 publications

References 13 publications

Comparison of the COX‐inhibiting nitric oxide donator AZD3582 and rofecoxib in treating the signs and symptoms of Osteoarthritis of the knee

Comparison of the COX‐inhibiting nitric oxide donator AZD3582 and rofecoxib in treating the signs and symptoms of Osteoarthritis of the knee

Cyclooxygenase Isozymes: The Biology of Prostaglandin Synthesis and Inhibition

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

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