Comparison of low-dose rofecoxib versus 1000 mg naproxen in patients with osteoarthritis

R. Myllykangas-Luosujärvi Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

H.S. Lu Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

S.L. Chen Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

D. Choon Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

C. Amante Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

C.T. Chow Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

G. Pasero Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

GY. Genti Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

B. Sarembock Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

C.A.F. Zerbini Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

F. Vrijens Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

A. Moan Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

D.B. Rodgers Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

L. De Tora Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

M. Laurenzi Kuopio University Hospital, Kuopio, Finland, Ren Min Hospital, BMU, Beijing, China, Ren Ji Hospital, Shanghai, China, University Hospital Kuala Lumpur, Kuala Lumpur, Malaysia, Phil. Gen. Hospital, Manila, Philippines, Veterans General, Taipei, Taiwan, Istituto di Patologia Medica Ospedale S. Chiara, Universitaa di Pisa, Pisa, Italy, Floa r Ferenc Hospital, Kistarcsa, Hungary, City Park Hospital, South Africa, Service o de Reumatologia do Hospital Helioa polis, Saa o Paulo, Brazil, Merck Research Laboratories, Rahway and Whitehouse Station, NJ, USA and MSD Brussels, Belgium, 1Members of the Study Groups are listed as contributing investigators in the acknowledgements section

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Abstract

Objective : To compare the efficacy and safety of rofecoxib 12.5 mg once daily to naproxen 500 mg twice daily in patients &#83 40 years of age with knee or hip osteoarthritis (OA). Methods : Two identical 6-week, randomized, double-blind studies were conducted (1 in Africa, Australia, Europe, Canada, Mexico, & South America; 1 in Asia). Primary endpoints were pain walking on a flat surface, patient global assessment of response to therapy, and investigator global assessment of disease status. Results : Overall, 944 patients participated. For all efficacy endpoints, treatment effects for rofecoxib and naproxen were comparable and seen at the first measures of efficacy. Both compounds were generally well-tolerated, with an improved gastrointestinal safety profile for rofecoxib versus naproxen. Conclusions : In these studies, rofecoxib 12.5 mg once daily (the lowest indicated dose) and naproxen 500 mg twice daily showed similar treatment effects in OA patients. Rofecoxib and naproxen were generally well tolerated.

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Comparison of low-dose rofecoxib versus 1000 mg naproxen in patients with osteoarthritis

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Comparison of low-dose rofecoxib versus 1000 mg naproxen in patients with osteoarthritis

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