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

Data presented today 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.
    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
anitplatelet 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 81mg 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.