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Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained With Naproxen Sodium
Date:11/7/2007

Data Suggests That Millions on Aspirin Therapy Can Safely Take Aleve for

Pain Without Compromising Cardiovascular Benefits

BOSTON, Nov. 7 /PRNewswire/ -- Data to be presented at the 71st annual meeting of the American College of Rheumatology (ACR) showed that when over- the-counter (OTC) naproxen sodium, commercially sold as Aleve(R), was added to an aspirin therapy regimen, there was no change in platelet aggregation measures versus baseline. Unlike ibuprofen, which can negate the intended cardiovascular benefit of aspirin therapy, an OTC dose of naproxen sodium did not change the antiplatelet effect profile seen with aspirin therapy alone.

The aggregation or accumulation of platelets can cause clotting in the arteries, which can lead to a heart attack or ischemic stroke. It has been reported that one in five Americans (an estimated 43 million) regularly take aspirin and globally, it is estimated that more than 90 million are taking aspirin for cardioprotection. Taken regularly, low-dose aspirin can help prevent one out of three heart attacks. However, the U.S. Food and Drug Administration (FDA) has recently mandated that ibuprofen products now carry a warning that there may be an interaction between ibuprofen and aspirin, which might render aspirin therapy less effective when used for its antiplatelet, cardioprotective effect.

"This study is good news for the millions of Americans who currently use low-dose aspirin therapy, and also need safe, over-the-counter pain relief for general aches and pains, including the minor pain of arthritis. These results tell us that Aleve doesn't interfere with aspirin the way some other analgesic treatments may, giving the consumer more freedom to make choices about pain relief without worrying about this drug interaction," said study author Michael Schiff, M.D., of the Denver Arthritis Clinic.

This research explored the effect of OTC doses of naproxen sodium (220 mg tid) or acetaminophen (1,000 mg qid) on the antiplatelet effect when administered together with low-dose aspirin therapy (81mg). Acetaminophen was used as a comparator as previous research has confirmed that it does not alter the platelet inhibition of low dose aspirin therapy. This clinical study did not measure the degree of molecular interaction, but the findings suggest that those on aspirin therapy can safely take OTC naproxen without compromising the intended cardiovascular benefit of aspirin. The findings will be presented via poster presentation on Friday, November 9.

These results are consistent with previous findings on the prescription dose of naproxen. Results of a previous study indicated that the prescription strength dose of naproxen (500mg bid)(1) administered two hours before or after low-dose aspirin did not interfere with the antiplatelet effects.

Methodology and Findings

This study was a single-center, randomized, open-label, 3-period trial with an intent-to-treat (ITT) population of 45 healthy men and women. Thirty seven participants who met the study criteria were given 81 mg of enteric- coated, low-dose aspirin once daily. After the first five days, all subjects demonstrated a 99 percent level of thromboxane (TXB2) inhibition.

The group was then divided into three groups for an additional five days of treatment:

-- The first group [n=12] continued on 81 mg of enteric-coated, low-dose

aspirin once daily;

-- The second group [n=12] were given 81 mg of enteric-coated, low-dose

aspirin once daily plus naproxen 220 mg three times daily; and

-- The third and final group [n=13] were given 81 mg of enteric-coated,

low-dose aspirin once daily plus 1,000 mg of acetaminophen four times

daily.

After the second round of treatment, all arms showed a 99% or higher thromboxane inhibition, supporting the conclusion that naproxen sodium does not change the antiplatelet effect profile seen with aspirin alone. The primary endpoint in the study was the inhibition of TXB2, measured through blood samples that were collected after the first five days of the study and again on day 11. The mean (+/- SD) degree of serum TXB2 inhibition was:

-- 99.7% (+/- 0.26%) for 81 mg of enteric-coated, low-dose aspirin once

daily

-- 99.7% (+/- 0.26%) for 81 mg of enteric-coated, low-dose aspirin once

daily plus naproxen 220 mg three times daily

-- 99.6% (+/- 0.45%) for 81 mg of enteric-coated, low-dose aspirin once

daily plus 1,000 mg of acetaminophen four times daily

An exploratory endpoint in which researchers evaluated thromboxane inhibition of those who discontinued naproxen sodium but continued to receive 81 mg of enteric-coated low-dose aspirin requires additional evaluation before conclusions can be drawn.

"These data, confirming that the OTC dose of naproxen sodium did not interfere with daily doses of 81 mg aspirin, add to the significant body of evidence that support the cardiovascular safety of naproxen," said study author Marc C. Hochberg, M.D., M.P.H., Professor of Medicine and Head of the Rheumatology and Clinical Immunology Division, University of Maryland School of Medicine.

About ALEVE and ALEVE Liquid Gels

Since its introduction as an OTC product in June 1994, ALEVE has been used by millions of Americans as a safe and effective pain reliever for more than a decade. ALEVE Liquid Gels, launched in March 2007, were developed to provide liquid-fast relief. With the convenience of all day relief with just two pills, ALEVE and ALEVE Liquid Gels can be used for the treatment of aches and pains due to minor arthritis pain, muscle aches, backache, headache, toothache, menstrual pain and pain associated with the common cold. Always read and follow label instructions.

ALEVE and ALEVE Liquid Gels are available at food, drug and mass retail outlets nationwide. For more information, visit http://www.ALEVE.com.

About Bayer Consumer Care

The Consumer Care Division of Bayer HealthCare LLC, is headquartered in Morristown, N.J. Bayer's Consumer Care Division is among the largest marketers of over-the-counter medications and nutritional supplements in the world. Some of the most trusted and recognizable brands in the world today come from the Bayer portfolio of products. These include Bayer(R) Aspirin, ALEVE(R), Flanax(R)/Apronax(R), Alka-Seltzer Plus(R), Bactine(R), RID(R), Phillips'(R) Milk of Magnesia, Midol(R), Alka-Seltzer(R), Talcid(R), Rennie(R), Canesten(R), Bepanthen(R), Bepanthol(R), One-A-Day(R) vitamins, FlintstonesTM vitamins, Supradyn(R), Redoxon(R), Berocca(R), Cal-D- Vita/Elevit(R), Vital 50 Plus(R), CardioAspirin(R).

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry based in Leverkusen/Germany. In 2006, the Bayer HealthCare subgroup generated sales amounting to some 11.7 billion Euro. The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology, Oncology and Primary Care. Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.

(1) Capone ML et al. Pharmacodynamic interaction of naproxen with low-dose aspirin in healthy subjects. J Am Coll Cardiol 2005; 45: 1302-1303.


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SOURCE Bayer Consumer Care
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