Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained With Naproxen Sodium

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

Pain Without Compromising Cardiovascular Benefits

Nov 07, 2007, 00:00 ET from Bayer Consumer Care

    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)
     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
     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
     -- 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
     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:

SOURCE Bayer Consumer Care