WASHINGTON, Nov. 11 /PRNewswire/ -- Over the past two years, there has been documented concern about the cardiovascular safety of some pain relievers and arthritis treatments.(1) New data presented at the 70th annual meeting of the American College of Rheumatology (ACR) examine the platelet inhibition of over-the-counter (OTC) doses of naproxen sodium and the findings add further to the significant body of evidence surrounding the product’s cardiovascular safety.
Platelets are an element in the blood that aid blood clotting.(2) Aggregating, or accumulating, platelets can cause clotting in the arteries, which can lead to a heart attack or ischemic stroke. Previous research has found the prescription strength dose of naproxen (550mg bid)(3) to have positive antiplatelet effects, but this study represents the first time that data have been collected at the OTC dose of 220mg bid and tid.
Measuring the inhibition of serum thromboxane B2 (TXB2), researchers determined that OTC doses of naproxen sodium produced an antiplatelet effect similar to enteric-coated, low-dose aspirin and prescription strength naproxen. Researchers did not examine any clinical endpoint, so the clinical significance of these data is undetermined. The findings will be presented on Monday, November 13th.
“As healthcare professionals who treat arthritis, we’re facing a dilemma in how to best treat our patients in need of pain relief -- many of whom have chosen to forego treatment because of concerns about medication safety,” said study author Michael Schiff, M.D., of the Denver Arthritis Clinic. “This new research gives us increased confidence in the cardiovascular profile of naproxen sodium, such as that found in Aleve, as an OTC pain reliever.”
Methodology and Findings
This study was a single-center, randomized, open-label, placebo- controlled, two-period crossover trial with an intent-to-treat (ITT) population of 48 healthy men and women. Forty one participants who met the study criteria were given one of three regimens of naproxen sodium (220 mg two times daily [n=11], 220 mg three times daily [n=9], 550 mg two times daily [n=11]) or placebo [n=10] for seven days. After a washout period of at least six days, subjects received aspirin 81 mg once daily for seven days for comparison purposes.
The primary endpoint in the study was the inhibition of TXB2, measured through blood and urine samples that were collected at baseline and 12 hours after the last dose of medication.
The mean (+/-SD) degree of serum TXB2 inhibition was * 97.9% (+/- 3.20%) for naproxen 220 mg two times daily * 99.4% (+/- 0.77%) for naproxen 220 mg three times daily * 99.6% (+/- 0.69%) for naproxen 550 mg two times daily
“These data, confirming that the OTC dose of naproxen sodium has a measurable antiplatelet effect, add to the body of evidence about the safety of this compound,” 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. “This information, along with other research reported in leading medical journals, helps to distinguish the safety of products within the NSAID class and supports the safety profile of naproxen sodium as an OTC pain reliever for patients with arthritis.”
About Naproxen/ALEVE
Naproxen has been used for more than 30 years in the United States as a prescription product. Since its introduction as an OTC product in June 1994, ALEVE(R) (naproxen sodium) has been used by millions of Americans as a safe and effective pain reliever for more than a decade. With the convenience of all day relief with just two pills, ALEVE 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.
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), Alka-Seltzer Plus(R), Bactine(R), RID(R), Phillips(R)’ Milk of Magnesia, Midol(R), Alka-Seltzer(R), One-A-Day(R) vitamins and Flintstones(TM) vitamins.
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 2005, the Bayer HealthCare subgroup generated sales amounting to some 9.4 billion Euro. Bayer HealthCare employed 33.800 people worldwide in 2005. The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics 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 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) Salpeter M, Gregor P, Meta-analysis: Cardiovascular events associated
with non-steroidal anti-inflammatory drugs. American Journal of
Medicine. 2006; 119: 552-559.
(2) American Heart Association Cardiac Glossary, http://americanheart.org/presenter.jhtml?identifier=3038599#pacemaker
(3) Capone M, Tacconelli S, Clinical pharmacology of platelet, monocyte
and vascular cyclooxygenase inhibition by naproxen and low-dose
aspirin in healthy subjects. Circulation. 2004; 109:1468-1471.
Bayer HealthCare, Consumer Care Division
CONTACT: Tricia McKernan of Bayer HealthCare, Consumer Care Division,Global Communications, +1-866-683-1126, tricia.mckernan.b@bayer.com; orDave Schemelia of HealthSTAR Public Relations, +1-212-532-0909,dschemelia@healthstarpr.com
