Rheumatology Medical News about osteoarthritis of the hip or knee;cyclooxygenase-inhibiting nitric oxide donator naproxinod

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Efficacy, safety, and tolerability of the cyclooxygenase-inhibiting nitric oxide donator naproxcinod in treating osteoarthritis of the hip or knee
Journal of Rheumatology, 06/11/09

Karlsson J et al. – This dose-finding study identified naproxcinod (a cyclooxygenase-inhibiting nitric oxide donator antiinflammatory drug) 750 mg bid as the upper dose for further therapeutic confirmatory clinical trials. Naproxcinod at all doses decreased mean systolic blood pressure (SBP) compared to an increase with rofecoxib in pts with osteoarthritis (OA).

Methods

Naproxcinod was evaluated in this phase 2 trial to determine its optimal dose in pts with OA
543 pts with OA of the hip or knee were randomized to receive naproxcinod:
- 750 mg once daily (qd)
- 750 mg twice daily (bid)
- 1125 mg bid, rofecoxib 25 mg qd, or
- Placebo for 6 wks
Primary efficacy variable was the within-patient change from baseline to the average of Wks 4 and 6 in WOMAC^™pain subscale score
Treatment-group differences were compared using ANCOVA with factors for treatment and country, and baseline pain subscale score as a covariate
Safety endpoints: vital signs and adverse events
Treatment-group differences in mean change from baseline to Wk 6 in SBP were compared using an ANCOVA with treatment and country as fixed factors and baseline SBP as covariate

Results

All active treatments showed reductions in WOMAC pain score vs placebo
Naproxcinod was well tolerated
The 750 mg bid dose had the best balance of benefit vs safety
All 3 naproxcinod doses showed a reduction in SBP, while an increase was shown for rofecoxib
Changes for the naproxcinod groups were better vs rofecoxib

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