Original Article
Evaluation of the Comparative Efficacy of Etoricoxib and Ibuprofen for Treatment of Patients With Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

https://doi.org/10.4065/80.4.470Get rights and content

OBJECTIVE

To directly compare the efficacy and safety of etoricoxib, 30 mg once daily, ibuprofen, 800 mg 3 times daily, and placebo for treatment of osteoarthritis (OA) of the hip and knee.

PATIENTS AND METHODS

A randomized, double-blind, placebocontrolled trial of patients with OA of the knee or hip was performed between February 2003 and November 2003 in 61 medical centers in the United States. Qualified patients aged 40 to 89 years were randomized to receive placebo, etoricoxib, 30 mg once daily, or ibuprofen, 800 mg 3 times daily, for 12 weeks. Primary efficacy end points included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales and Patient Global Assessment of Disease Status. Response to treatment was assessed by the time-weighted average change from baseline over 12 weeks.

RESULTS

In 528 patients, baseline values for the 3 primary end points ranged from 67.78 to 72.60 mm (0-100 mm visual analog scale). Near-maximal efficacy was achieved by week 2 with both active treatments and sustained over the course of the trial. During the 12-week period, least squares mean changes in the primary end points (Western Ontario and McMaster Universities Osteoarthritis Index and Patient Global Assessment of Disease Status subscales) ranged from −16.53 to −13.55 mm, −27.89 to −23.68 mm, and −26.53 to −22.97 mm in the placebo, etoricoxib, and ibuprofen groups, respectively. Both etoricoxib and ibuprofen were more effective (P<001) than placebo for all primary end points. Etoricoxib and ibuprofen treatment responses for the primary end points were determined to be comparable with use of prespecified comparability criteria. Results for all other efficacy end points were consistent with responses observed for the primary end points. Etoricoxib and ibuprofen generally were well tolerated.

CONCLUSIONS

For patients with OA, treatment with etoricoxib, 30 mg/d, is well tolerated and provides sustained clinical effectiveness that is superior to placebo and comparable to ibuprofen, 2400 mg/d.

Section snippets

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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    This study was funded by Merck Research Laboratories, Rahway, NJ.

    1

    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.

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