Nitronaproxen Better Than Naproxen or Ibuprofen for Patients With Osteoarthritis and
Nitronaproxen Better Than Naproxen or Ibuprofen for Patients With Osteoarthritis and Hypertension: Presented at ASH (HYP)
By Crina Frincu-Mallos, PhD
NEW YORK -- May 4, 2010 -- Mean increases from baseline in the 24-hour systolic blood pressure values were smaller in patients with osteoarthritis on nitronaproxen, compared with patients on either naproxen or ibuprofen, according to a study presented here at the American Society of Hypertension (ASH) 25th Annual Scientific Meeting and Exposition.
William B. White, MD, University of Connecticut School of Medicine, Farmington, Connecticut, presented the data in a Featured Posters session on May 2.
"These findings have important clinical implications for osteoarthritis patients with hypertension," explained Dr. White, as these are "the first data to show a lesser effect of nitronaproxen on blood pressure, compared with ibuprofen."
Nonsteroidal anti-inflammatory drugs are known to destabilise the 24-hour blood pressure control in patients with osteoarthritis who are also being treated for hypertension, due in part to interference with vasodilatation through prostacyclin inhibition and increased volume retention.
After systemic absorption, this new compound releases nitric oxide, hence it is considered a cyclooxygenase-inhibiting nitric oxide donator, explained Dr. White.
The main objective of this study was to assess the 24-hour blood pressure profile of nitronaproxen in comparison with conventional therapy, naproxen, and ibuprofen. Secondary objectives included the evaluation of safety and tolerability of nitronaproxen, compared with naproxen and ibuprofen.
The investigators studied the 24-hour ambulatory systolic blood pressure effect of 2 doses of nitronaproxen (750 and 375 mg BID) versus 2 equimolar doses of naproxen (500 and 250 mg BID) and ibuprofen 600 mg TID for 16 weeks.
A total of 299 patients were randomised; all had osteoarthritis of the hip or knee, requiring anti-inflammatory therapy. All patients had controlled hypertension (<140/90 mm Hg) on 1 or 2 antihypertensive agents.
Baseline systolic blood pressure values were similar between groups.
The percentage of patients who completed the trial varied by treatment group: highest in the nitronaproxen 750 mg group (81%), compared with 73% in the naproxen 250 mg group, and only 64% in the ibuprofen group.
Nitronaproxen had numerically smaller increases in 24-hour systolic blood pressure, compared with both naproxen (-2.0 mm Hg; P = .374), and ibuprofen (-3.4 mm Hg; P = .230).
"These changes from the baseline were not statistically significant for nitronaproxen, relative to the comparator treatment groups," said Dr. White, adding that loss of statistical power occurred due to dropouts, especially in the ibuprofen and naproxen 250 mg groups.
These data confirm findings from prior studies with clinic blood pressure, which showed that nitronaproxen induces less destabilisation of hypertension control compared with naproxen.
Among the drug-related serious adverse events were hypertension, dyspepsia, peripheral oedema, and diarrhoea.
Funding for this study was provided by NicOx, S.A.
[Presentation Title: The Cyclooxygenase Inhibiting Nitric Oxide Donator (CINOD) Naproxcinod Induces Less Increases in the 24-hour Systolic Blood Pressure Than Naproxen and Ibuprofen in Patients With Osteoarthritis and Hypertension. Abstract PO-1]
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