Le Napro sur 1 an
Efficacy and Safety of Naproxcinod in Patients with Osteoarthritis of the Knee: A 53-Week Prospective Randomized Multicenter Study Original Research Article
Seminars in Arthritis and Rheumatism, In Press, Corrected Proof, Available online 9 September 2010
Thomas J. Schnitzer, Marc C. Hochberg, Christopher E. Marrero, Brigitte Duquesroix, Hayet Frayssinet, Maarten Beekman
Objective:
Comparison of naproxcinod (375 and 750 mg), placebo (up to 13 weeks), and naproxen 500 mg (all bid) for treatment of osteoarthritis (OA) signs and symptoms.
Methods:
A 53-week, randomized, double-blind, parallel-group study. One thousand twenty patients with primary knee OA were randomized to naproxcinod 750 mg, naproxcinod 375 mg, naproxen 500 mg, or placebo (all bid). Coprimary efficacy endpoints were Western Ontario and McMaster Universities Osteoarthritis Index (WOMACTM) pain and function subscales and patient overall rating of disease status. An analysis of covariance model tested superiority for both naproxcinod doses over placebo at week 13, and noninferiority of naproxcinod 750 mg bid versus naproxen at weeks 13 and 26.
Results:
Least-square mean changes from baseline were greater for both naproxcinod doses compared with placebo at week 13 for WOMAC pain (−31.3 [standard error 1.67], −28.1 [1.64], and −20.4 [1.62] mm with naproxcinod 750 mg bid [P < 0.0001], 375 mg bid [P = 0.0008], and placebo, respectively), WOMAC function (−27.8 [1.60], −23.8 [1.58], and −14.9 [1.56] mm, respectively, P < 0.0001), and patient overall rating of disease status (1.00 [0.061], 0.81 [0.060], and 0.49 [0.059], respectively, P < 0.0001). Naproxcinod 750 mg bid was noninferior to naproxen at weeks 13 and 26. Naproxcinod was well tolerated, with no notable differences in orthostatic blood pressure response between treatments.
Conclusion:
Naproxcinod 750 mg bid and 375 mg bid demonstrated superior efficacy over placebo for treatment of OA and were well tolerated over 1 year. Naproxcinod 750 mg bid was noninferior to naproxen 500 mg bid.
Article Outline
Materials and Methods
Study Population
Study Design and Treatments
Criteria for Evaluation
Statistical Analysis
Results
Patient Disposition: 13-week ITT Population and 53-week Safety Population
Efficacy at Week 13
Long-Term Efficacy—Weeks 26 and 52
General Safety
Blood Pressure
Discussion
Acknowledgements
References
noto che non ti sei accorto dove lo scorso anno il vs ex sepecialone...faceva giocare etooooo