1University of Connecticut School of Medicine, Farmington, USA
2Northwestern University School of Medicine, Chicago, USA
3NicOx S.A., Sophia-Antopolis, France
Background: 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.
Methods: 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.
Results: 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).
Conclusions: 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.