By Louise Gagnon
MONTREAL -- September 14, 2009 -- A novel cyclooxygenase inhibiting nitric oxide donator appears to be as effective as a standard nonsteroidal anti-inflammatory drug (NSAID) without increasing blood pressure in patients with osteoarthritis (OA) of the knee, according to a study presented here at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI).
"We compared the typical NSAID naproxen with a new molecule called naproxcinod," said Pablo Altman, MD, Medical Affairs, NicOx Inc, Warren, New Jersey, in a poster presentation on September 12. "We wanted to show that the efficacy was similar to naproxen."
The study compared outcomes in patients with primary OA of the knee, aged 40 years and older, who were randomised in a 1:1:1:1 ratio to receive naproxcinod 375 mg BID, naproxcinod 750 mg BID, naproxen 500 mg BID, or placebo. The intent-to-treat population consisted of 1,011 patients.
The study's primary endpoint was to evaluate if either dose of naproxcinod, taken twice daily, was superior to placebo in diminishing signs and symptoms of OA after 13 weeks of therapy.
The new molecule, naproxcinod, contains the primary metabolite naproxen and the nitric oxide (NO) donating moiety, explained Dr. Altman. It is the NO donation that renders the molecule better tolerated, he added.
"There is a very well-studied increment of blood pressure associated with NSAIDs," he said. "Some produce more than others. They can increase cardiovascular problems like stroke."
Investigators measured the mean change from baseline after 13 weeks of therapy in Western Ontario and McMaster Universities (WOMAC) pain, function subscale scores, and patient's global assessment of disease status.
Researchers found that naproxcinod, at both doses, was more effective than placebo as measured by WOMAC pain and function and in the patient's global assessment of disease status (P <= .0004). The higher dose of naproxcinod was noninferior to naproxen 500 mg at week 13.
"We see similar efficacy, and we see a positive effect on blood pressure [with naproxcinod]," he said. "We can see a similar effect on blood pressure with this molecule as we see with placebo."
Funding for this study was provided by NicOx Inc.
[Presentation title: A Randomized, Parallel Group, Double-Blind, Placebo and Naproxen Controlled, Multi-Center Phase 3 Study of Naproxcinod in Subjects With Osteoarthritis of the Knee: Efficacy Results Following 13-Week Treatment. Abstract 321]
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