TY - JOUR
T1 - Etoricoxib versus naproxen in patients with rheumatoid arthritis
T2 - A prospective, randomized, comparator-controlled 121-week trial
AU - Matsumoto, Alan
AU - Melian, Agustin
AU - Shah, Arvind
AU - Curtis, Sean P.
N1 - Funding Information:
This study was funded by a grant from Merck & Co, Inc. The authors thank Anish Mehta of Merck Research Laboratories and Wendy Horn for their assistance in the writing of this manuscript. They also thank Dr Paul Cavanaugh of Merck Research Laboratories for his critical review of the manuscript.
PY - 2007/9
Y1 - 2007/9
N2 - Background: Etoricoxib is a cyclooxygenase-2 (COX-2) selective inhibitor effective in the treatment of rheumatoid arthritis. An initial 12-week treatment study found that etoricoxib (90 mg once daily) was more effective than naproxen (500 mg twice daily) or placebo in treating rheumatoid arthritis. The present two-part extension of that study was performed to monitor tolerability and examine long-term efficacy of etoricoxib 90 mg or 120 mg compared with naproxen. Methods: Patients completing the initial 12-week study and those discontinuing due to lack of efficacy, were eligible for the Extension Study Part I (12-52 weeks) and assigned (2:1:2 ratio) to receive etoricoxib (90 mg or 120 mg daily) or naproxen (500 mg twice daily); these patients remained on the same therapy for Extension Study Part II (52-121 weeks). Primary outcome measures included investigator and patient assessment of disease activity, and tender and swollen joint counts. Results: Of 816 patients enrolled in the initial 12-week trial, 717 continued into the Extension Study Part I; 505 patients completed and 390 entered the Extension Study Part II, with 283 patients completing 121 weeks. Patients receiving etoricoxib (90 mg) or naproxen throughout the study experienced sustained efficacy in all outcomes, as did patients transitioning to etoricoxib (120 mg) following the initial 12-week trial. Patients transitioning from placebo to etoricoxib (90 mg) experienced rapid, sustained improvements in all outcome measures. Conclusion: In conclusion, etoricoxib provided sustained efficacy throughout the 121-week study, with efficacy comparable to naproxen.
AB - Background: Etoricoxib is a cyclooxygenase-2 (COX-2) selective inhibitor effective in the treatment of rheumatoid arthritis. An initial 12-week treatment study found that etoricoxib (90 mg once daily) was more effective than naproxen (500 mg twice daily) or placebo in treating rheumatoid arthritis. The present two-part extension of that study was performed to monitor tolerability and examine long-term efficacy of etoricoxib 90 mg or 120 mg compared with naproxen. Methods: Patients completing the initial 12-week study and those discontinuing due to lack of efficacy, were eligible for the Extension Study Part I (12-52 weeks) and assigned (2:1:2 ratio) to receive etoricoxib (90 mg or 120 mg daily) or naproxen (500 mg twice daily); these patients remained on the same therapy for Extension Study Part II (52-121 weeks). Primary outcome measures included investigator and patient assessment of disease activity, and tender and swollen joint counts. Results: Of 816 patients enrolled in the initial 12-week trial, 717 continued into the Extension Study Part I; 505 patients completed and 390 entered the Extension Study Part II, with 283 patients completing 121 weeks. Patients receiving etoricoxib (90 mg) or naproxen throughout the study experienced sustained efficacy in all outcomes, as did patients transitioning to etoricoxib (120 mg) following the initial 12-week trial. Patients transitioning from placebo to etoricoxib (90 mg) experienced rapid, sustained improvements in all outcome measures. Conclusion: In conclusion, etoricoxib provided sustained efficacy throughout the 121-week study, with efficacy comparable to naproxen.
KW - Etoricoxib
KW - NSAIDs
KW - Naproxen
KW - Selective COX-2 inhibitors
UR - http://www.scopus.com/inward/record.url?scp=36049035922&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=36049035922&partnerID=8YFLogxK
U2 - 10.1185/030079907X219625
DO - 10.1185/030079907X219625
M3 - Article
C2 - 17697449
AN - SCOPUS:36049035922
VL - 23
SP - 2259
EP - 2268
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
SN - 0300-7995
IS - 9
ER -