Effets du Naproxcinod après 13 semaines de traitement

We studied the effects of 2 doses of naproxcinod (375 mg and 750 mg bid) on systolic BP vs. naproxen 500 mg bid and placebo bid in a 13-week double-blind, randomized clinical trial involving 918 patients with a history of knee OA knee requiring chronic use of anti-inflammatory therapy; 50% were hypertensive based on medical and treatment history.
Results: Patients were 61 +/- 9 years, 70% female, 86% white, with a mean BMI of 33 +/- 8 kg/m2. As shown in the Table, baseline systolic BPs were similar in the 4 treatment groups and slightly higher in the hypertensive population. At week 13, meanchanges from baseline in systolic BP in patients on naproxcinod 750 mg bid were similar to placebo (p = 0.505) and differentiated from naproxen (p = 0.015). In patients with hypertension, the proportion of patients whose systolic BP rose by > 10 mmHg was greater on naproxen than on naproxcinod and placebo.
In conclusion, these data demonstrate that naproxcinod induces less destabilization of BP compared to naproxen 500 mg, and has a similar effect to placebo. These findings may have important clinical implications for OA patients with hypertension.
Naproxcinod 750 mg: -4.1 +- 1.2
Naproxcinod 375 mg: -2.6 +-1.3
Naproxen 500 mg: -1.3 +- 1.3
Placebo: -4.6+- 1.4



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