Original ArticleEvaluation of the Comparative Efficacy of Etoricoxib and Ibuprofen for Treatment of Patients With Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial
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PATIENTS AND METHODS
The protocol for this study was approved by the institutional review boards of each study center. All patients provided written informed consent before participating in the study, which was performed between February 2003 and November 2003 in 61 medical centers throughout the United States.
We enrolled otherwise healthy male and female patients aged 40 years or older who had a clinical and radiographic diagnosis of OA of the knee (tibiofemoral joint) or hip for at least the previous 6 months as
Patients
A total of 862 patients were screened, of whom 528 met the eligibility criteria and were randomized (Figure 1). A higher proportion of patients in the etoricoxib treatment group completed the trial compared with those in the placebo and ibuprofen groups. The most common reason for discontinuing the study was lack of efficacy, with the highest proportion of patients discontinuing for this reason in the placebo group (29.8%; P<001 vs both active treatments) compared with 11.7% and 14.3% in the
DISCUSSION
We used validated clinical end points18, 19, 20 to show the efficacy of etoricoxib, 30 mg once daily, for treatment of the signs and symptoms of OA in patients induced to experience a flare of their OA symptoms. Consistent with a previous dose-ranging study,21 the results of this trial confirm the superior clinical efficacy of etoricoxib, 30 mg/d, compared with placebo for treatment of patients with OA of the hip and knee. Near-maximal efficacy was achieved within 2 weeks after initiation of
CONCLUSION
For patients with OA, treatment with etoricoxib, 30 mg/d, is well tolerated and provides sustained therapeutic efficacy that is superior to placebo and clinically comparable to ibuprofen, 2400 mg/d.
Members of the Protocol 071 Study Group. Raymond A. Adelizzi, DO; Jeffrey A. Alper, MD; Ralph M. Vicari, MD; Lawrence Alwine, DO; Allan B. Aven, MD; Herbert S. Baraf, MD; Scott W. Baumgartner, MD; Barry I. Bockow, MD; Francis X. Burch, MD; Barbara A. Caciolo, MD; Stanley B. Cohen, MD; Harry Collins,
Acknowledgments
The authors thank Nicole Cichanowitz and Suruchi S. Athalye of Merck Research Laboratories for their assistance with conducting the study and Dr Paul F. Cavanaugh of Merck Research Laboratories for his assistance in preparation of the submitted manuscript.
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Clinical trials and future perspectives of antiinflammatory agents
2023, Recent Developments in Anti-Inflammatory TherapyThe use of cyclooxygenase-2 inhibitors for improvement of efficacy of radiotherapy in cancers
2016, Drug Discovery TodayCitation Excerpt :Lumiracoxib is a selective COX-2 inhibitor that does not have a sulfonamide or sulfone moiety in its structure, and is approved for use in the UK [22]. Etoricoxib, another COX-2 inhibitor, is as effective as ibuprofen with fewer adverse reactions, and is actively under research for evaluation of its cardiovascular safety profile in long-term use [23]. Parecoxib is a water-soluble prodrug of valdecoxib and is not likely to be approved considering the safety concerns of rofecoxib [24].
Nonsteroidal Anti-Inflammatory Drugs: Adverse Effects and Their Prevention
2010, Seminars in Arthritis and RheumatismReview article on assess the non-pharmacological management for knee osteoarthritis
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This study was funded by Merck Research Laboratories, Rahway, NJ.
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Drs Boice and Reicin and Mss Ko and Aversano are employees of Merck & Co, Inc, and own stock and/or hold stock options in the company. A complete list of members of the Protocol 071 Study Group appears at the end of this article.