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| |  Over-the-Counter Naproxen Shows Cardio-Protective Effect By Bruce Sylvester WASHINGTON, DC -- November 14, 2006 -- Popular over-the-counter painkiller Aleve (naproxen 220mg) appears to be as safe for the cardiovascular system as the prescription-strength version of the drug (naproxen 550 mg), and appears to have similar antiplatelet effects to that of daily low-dose aspirin. "After the exit of Vioxx and Bextra from the market, when people come to me with pain and want something for it, they also want to know if the medicine is going to cause increased cardiovascular risk," said lead investigator Michael Schiff, MD, clinical professor of medicine, rheumatology division, University of Colorado School of Medicine, and medical director, Denver Arthritis Clinic Research Unit, Denver, Colorado. "The data in this study speaks to that issue," he continued. "Aleve will not be risky in that sense and it could be cardio-protective." The single-center, randomized, open-label, placebo-controlled, 2-period crossover study was presented here on November 13th at the American College of Rheumatology - Association of Rheumatology Health Professionals Annual Scientific Meeting (ACR-ARHP). Dr. Schiff and his colleagues studied the effects of Aleve in 41 subjects who were randomized to 1 of 4 treatments for 7 days: naproxen twice-daily 220 mg (11 subjects); naproxen 3 times daily 220 mg (9 subjects); naproxen twice-daily 550 mg (11 subjects); placebo (10 subjects). At the end of the 7 days, each subject waited at least 6 days until taking aspirin 81 mg once daily for 7 days, for comparison purposes. The researchers used a standard blood and urine marker (serum thromboxane B2) to measure platelet inhibition. Results showed that both 220-mg naproxen doses achieved a powerful (98-99%) anti-platelet effect similar to that of the prescription version (550 mg) and to low-dose aspirin. Even though this was a laboratory study and not a large clinical trial, Dr. Schiff noted that the laboratory marker they used established enough power to enable the researchers to reach their conclusions. "Aleve will not be risky in a cardioprotective sense, and it could be cardio-protective,' Schiff said. "Also, since it is as cardio-protective as the higher dose naproxen and since lower dosing of this drug is better in terms of gastrointestinal side effects, this is good news on that front too." The study was sponsored by Bayer.
[Presentation title: Effect of Over-the-Counter Doses of Naproxen Sodium on Inhibition of Platelet Cyclooxygenase-1 in Healthy Volunteers. Abstract 513]
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