Effects of the Cyclooxygenase Inhibiting Nitric Oxide Donator Naproxcinod Versus Naproxen on Systemic Blood Pressure in Patients With Osteoarthritis

Traditional nonsteroidal anti-inflammatory drugs are associated with
the destabilization of blood pressure (BP) control, particularly in
hypertensive patients treated with blockers of the renin-angiotensin
system. To assess the potential impact of nitric oxide donation, the
effects of naproxcinod with naproxen and placebo on changes in BP were
compared in a randomized clinical trial of 916 patients with
osteoarthritis after 13 weeks of therapy. In addition, the effects of
naproxcinod versus naproxen and placebo on systolic BP in patients with
hypertension treated with renin-angiotensin system blockers were
evaluated. Naproxcinod 750 mg twice daily reduced systolic BP compared
to naproxen 500 mg twice daily (p <0.02). The 2 doses of naproxcinod
showed reductions from baseline in diastolic BP relative to naproxen (p
<0.04) and similar changes compared to placebo. In 207 patients with
hypertension treated with renin-angiotensin–blocking agents alone or
with diuretics, the difference in mean change from baseline in systolic
BP between naproxen 500 mg and naproxcinod 750 mg was 6.5 mm Hg in
favor of naproxcinod (p <0.02). The proportion of patients in the
overall population with systolic BP increases ≥10 mm Hg was greater
with naproxen 500 mg (22%) compared to naproxcinod 750 mg (14%, p =
0.04), naproxcinod 375 mg (14%, p = 0.055), and placebo (15.6%, p =
0.155). In conclusion, naproxcinod did not induce elevations of BP seen
with naproxen, and it had similar effects on BP to that of placebo in
patients with osteoarthritis.

Full text at AJC