Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Time to Onset of Gastrointestinal Adverse Events of Naproxcinod vs. Naproxen and Placebo in Patients with Osteoarthritis.

Cryer2,  Byron, Lanas1,  Angel, Fleming4,  Rosanna, Dolphi3,  Fabrizio, Aguirre3,  Diana, Duquesroix3,  Brigitte

Aragon Health Sciences Institute, University of Zaragoza
Department of Veterans Affairs Medical Center
NicOx SA
NicOx, Inc

Background:

Naproxcinod is a first-in-class COX-Inhibiting Nitric Oxide Donator (CINOD). Previous studies showed naproxcinod was effective compared to placebo in osteoarthritis (OA) patients.

Objectives:

To evaluate the time to onset of GI adverse events (AEs) of naproxcinod 750 mg bid and naproxcinod 375 mg bid vs naproxen 500 mg bid and placebo bid in OA patients.

Methods:

The safety populations were pooled from three Phase 3 OA studies (13 weeks of treatment) including two dose regimens of naproxcinod, naproxen and placebo. GI AEs and discontinuations due to GI AEs were part of a pre-planned descriptive statistical analysis. A post-hoc analysis of time to onset of GI AEs and discontinuations due to GI AEs among the different treatment groups was performed by estimating the distributions of the times to onset using Kaplan-Meier methods and comparing the distributions among the treatment groups using log rank test.

Results:

A total of 2741 patients were included in the analysis: 801 on naproxcinod 750 mg, 489 on naproxcinod 375 mg, 638 on naproxen 500 mg and 813 on placebo. Demography and baseline characteristics were well balanced among groups and reflected those of the general OA population. At least one GI AE was reported by 138 (17.2%) patients on naproxcinod 750 mg bid, 69 (14.1%) on naproxcinod 375 mg bid, 128 (20.1%) on naproxen and 109 (13.4%) on placebo. Few patients discontinued due to at least one GI AE: 27 (3.4%) on naproxcinod 750 mg bid, 9 (1.8%) on naproxcinod 375 mg bid, 29 (4.5%) on naproxen and 27 (3.3%) on placebo.

Time to onset of GI AEs for the different treatment groups is presented below.

Overall, the difference among the treatment groups was significant (log Rank p-value=0.0050). Time to onset of discontinuations due to GI AEs showed a similar trend but the difference was not significant among treatment groups.

Conclusions:

This analysis showed that over the 13 weeks of treatment the onset of GI AEs was less likely to have occurred for naproxcinod-treated patients than for naproxen-treated patients. A similar trend was observed for discontinuations due to GI AEs.

References:

HCT 3012-X-301, -302 up to 13 weeks of treatment, -303.

To cite this abstract, please use the following information:
Cryer, Byron, Lanas, Angel, Fleming, Rosanna, Dolphi, Fabrizio, Aguirre, Diana, Duquesroix, Brigitte; Time to Onset of Gastrointestinal Adverse Events of Naproxcinod vs. Naproxen and Placebo in Patients with Osteoarthritis. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :953
DOI: 10.1002/art.28720

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