Nonsteroidal anti-inflammatory drugs (NSAIDs) may induce destabilization of 24-hour blood pressure (BP) control in patients with osteoarthritis (OA) and treated hypertension, due in part to reduction in prostacyclin and increases in volume retention. Hence, we assessed the 24-hour BP effects of naproxcinod and the conventional NSAIDs naproxen and ibuprofen.
The 24-hour ambulatory systolic BP effect of 2 doses of naproxcinod (750 and 375 mg bid) vs 2 equimolar doses of naproxen (500 and 250 mg bid) and ibuprofen (600 mg tid) were studied in a 1:1:1:1:1 randomization scheme in a 16-week (90 days of active treatment) double-blind, randomized study involving 299 patients with OA, all of whom had controlled hypertension (< 140/90 mmHg) on 1-2 antihypertensive agents.
At baseline, patients were 61 ± 9 years, 64% female, and 83% non-black. Baseline systolic BPs were similar in the 5 groups (Table). Mean increases from baseline in the 24-hour systolic BP were numerically less in patients on naproxcinod compared to both naproxen and ibuprofen (Table).
These data confirm that the mean 24-hour BP increase was less with naproxcinod compared to naproxen. Further, these are the first data to show a lesser BP effect of naproxcinod versus ibuprofen. These findings have important clinical implications for OA patients with hypertension.
1University of Connecticut School of Medicine, Farmington, USA
2Northwestern University School of Medicine, Chicago, USA
3NicOx S.A., Sophia-Antopolis, France