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The American Journal of Cardiology, In Press, Corrected Proof, Available online 2 March 2011 William B. White, Thomas J. Schnitzer, George L. Bakris, Hayet Frayssinet, Brigitte Duquesroix, Michael Weber
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Effects of Naproxcinod on Blood Pressure in Patients with Osteoarthritis
William B. White, MDa,*, Thomas J. Schnitzer, MD, PhDb, George L. Bakris, MDc,
Hayet Frayssinet, MScd, Brigitte Duquesroix, MDd, and Michael Weber, MDe
Nonsteroidal anti-inflammatory drugs are associated with increases in blood pressure (BP),
particularly in patients treated with antihypertensive therapy. Naproxcinod is a nitric
oxide-donating cyclooxygenase inhibitor in development for osteoarthritis (OA). Thus, we
characterized the effects of naproxcinod on BP in an integrated safety analysis of 3 pivotal
trials of patients with OA of the hip or knee involving 2,734 patients. The changes from
baseline in the systolic BP after 13 weeks of therapy with naproxcinod (375 and 750 mg),
naproxen 500 mg (equipotent to naproxcinod 750 mg), or placebo twice daily were evaluated
in all patients and in the subgroup taking renin-angiotensin system inhibitors. Heterogeneity
testing showed no treatment-by-study interaction. The effects of naproxcinod
750 mg on the systolic BP was not different from placebo (mean change from baseline vs
placebo 0.4 mm Hg, 95% confidence interval 1.6 to 0. Naproxen increased the systolic
BP relative to placebo (mean change from baseline vs placebo 1.4 mm Hg, 95% confidence
interval 0.1 to 2.7). In the renin-angiotensin system inhibitor–treated patients, the effect of
naproxcinod 750 mg compared to naproxen 500 mg in the changes from baseline in the systolic
BP was 4.3 mm Hg (95% confidence interval 8.5 to 0.0). In conclusion, naproxcinod had
effects on BP similar to that of placebo in patients with OA. These results imply that naproxcinod
would be less likely to alter systolic BP control in patients with OA than a conventional
nonsteroidal anti-inflammatory drug, particularly in those treated with renin-angiotensin system
inhibitor agents. © 2011 Elsevier Inc. All rights reserved. (Am J Cardiol 2011)