New Data Presented at European Society of Cardiology Congress 2005 Reinforces Relative Safety of Low-Dose Aspirin Over Higher Doses

STOCKHOLM, Sweden, Sept. 6 /PRNewswire/ — It is estimated that more than 30 million people worldwide take aspirin, either alone or in combination with other medications, for preventive reasons. However, aspirin therapy may be associated with serious side effects such as gastrointestinal problems and bleeding. The results of a recent meta-analysis, which were presented today at the European Society of Cardiology Congress 2005 in Stockholm, provide new information for physicians and patients about the relationship between aspirin dosage and risk of bleeding complications.

“There is a significant amount of compelling evidence that aspirin therapy can help to reduce the incidence of acute myocardial infarction (heart attack) and secondary stroke,” said Victor Serebruany, MD, PhD from HeartDrug Research Laboratories and Johns Hopkins University, and lead study investigator. “However, there are very few analyses that specifically examine the link between aspirin monotherapy and serious side effects such as the incidence of gastrointestinal bleeding. We conducted this analysis in order to provide physicians with needed information that may help them to better determine appropriate doses of aspirin therapy for their patients.”

The analysis, titled “The Risk of Bleeding Complications After Different Doses of Aspirin,” was designed to determine and compare the risk of bleeding for patients who took low (<100mg), moderate (100-200mg), and high dose aspirin (>200mg). Study investigators conducted a retrospective analysis of data from 31 clinical trials that involved 192,036 patients. In order to meet the analysis criteria, the studies had to include clinical follow-up for at least one month and a record of detailed bleeding complications. Study investigators analyzed the data by dividing patients into groups based on their aspirin therapy dose and also classified bleeding complications into six categories – minor, major, gastrointestinal, stroke, fatal/life-threatening and total. The analysis demonstrated that patients who were on the lowest dose of aspirin therapy recorded the lowest average rate, 3.26 percent, for total bleeding events versus 11.31 percent for moderate dose aspirin (100-200mg) and 9.40 percent for high dose aspirin (>200mg).

“These new data demonstrate that patients on low-dose aspirin therapy experienced the lowest risk of bleeding complications,” said Steven R. Steinhubl, MD, Director of Cardiovascular Research & Education at the University of Kentucky and study investigator. “The data also provide further confirmation that there is a dose dependent relationship between aspirin and increased risk of bleeding complications. Based on the results of this and other analyses, it would be prudent for physicians and patients to consider a lower dose aspirin as a preventive therapy.”

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McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc., markets prescription and over-the-counter (OTC) pharmaceutical products. The company’s OTC products include complete lines of TYLENOL(R) acetaminophen, which celebrates 50 years of trust and innovation in 2005, and MOTRIN(R) IB ibuprofen for adults and children. Prescription products include CONCERTA(R) (methylphenidate HCl extended-release tablets) and FLEXERIL(R) (cyclobenzaprine HCl 5 mg tablets). Other McNeil brands include IMODIUM(R) A-D anti-diarrheal, ST. JOSEPH(R) 81 mg Adult Aspirin and NIZORAL(R) A-D Shampoo.

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CONTACT: Gloria Vanderham of Ortho McNeil – Consumer PharmaceuticalsNutritionals Group, +1-908-927-3756, gvanderh@ompus.jnj.com