Patients on Experimental Drug Prasugrel Have a Reduced Risk of Heart Related Death, Heart Attacks and Strokes

Washington, DCResults from the TRITON TIMI-38 clinical trial were announced today at the American Heart Association meeting and published simultaneously in the New England Journal of Medicine

The head-to-head TRITON study involved 13,608 patients worldwide and was designed to study the effectiveness and safety of prasugrel versus clopidogrel in patients having suffered a heart attack or unstable angina due to total or partial blockage of a coronary artery. These patients had undergone a procedure called angioplasty or Percutaneous Coronary Intervention.

Prasugrel and clopidogrel are in a class of medications called antiplatelet drugs. They work by helping to prevent harmful blood clots which can result in a heart attack or stroke. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface.

The TRITON TIMI-38 clinical trial was conducted in conjunction with the
TIMI Study Group at Harvard Medical School and Brigham and Women's Hospital in Boston.

The global trial demonstrated that treatment with prasugrel was shown to be significantly more effective than treatment with clopidogrel in patients who have already suffered a heart attack or have unstable angina, and have had a procedure to reopen their coronary arteries.

According to Elliott Antman, the director of doctors in Brigham and Women's Hospital's cardiac unit, patients on Prasugrel were 19% less likely to have a stroke, heart attack or death from a cardiovascular cause compared with patients on clopidogrel (Plavix), but were 32% more likely to suffer a serious bleeding event.

An analysis of subgroups of patients in the study suggested those with a
• history of smoking,
• stroke,
• those age 75 and older as well as
• those who weighed less than 60 kilograms (132 pounds)
had "less clinical efficacy and greater absolute levels of bleeding than the overall cohort."

Antman said most of the excess bleeding and fatal bleeding occurred in patients who've suffered a previous stroke and said if approved, the drug shouldn't be used in that group.

Daiichi Sankyo Company, and Eli Lilly and Company, which are co-developing prasugrel, will conduct a Phase III Study in conjunction with the Duke Clinical Research Institute (DCRI), to evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack or stroke in ACS patients who are to be medically managed without planned revascularization (a procedure to reopen blocked arteries). Currently,more than 50 percent of patients presenting with ACS worldwide are managed without acute intervention.

The study, TRILOGY ACS (Targeted platelet Inhibition to clarify the Optimal strategy to medically manage Acute Coronary Syndromes), will include approximately 10,000 patients at more than 800 hospitals in 35 countries. Lead study investigator will be E. Magnus Ohman, M.D., Professor of Cardiology at Duke University School of Medicine.

A number of risk factors, individually or in combination, can lead to heart disease:
• Smoking
• Physical inactivity
• Diets rich in saturated fat
• Obesity/being overweight
• High blood pressure
• High blood cholesterol
• Diabetes
• Stress
• A family history of heart disease

Cardiovascular disease is the leading cause of death in the U.S. and worldwide, killing 16.7 million people each year.

Acute heart attacks and unstable angina, called acute coronary syndrome, affect more than 840,000 Americans each year and 800,000 in Europe. Even with current medical interventions, 300,000 people experience recurrent heart attacks and 500,000 people die from heart attacks annually in the United States.

Cardiovascular disease is the number one killer in Canada. It is also the most costly disease in Canada, putting the greatest burden on their national health care system.

According to The Growing Burden of Heart Disease and Stroke in Canada 2003, eight in ten Canadians have at least one risk factor for cardiovascular disease and 11% have three risk factors or more. Cardiovascular disease is the leading cause of death in the UK, killing 208,000 patients per year. Around 227,000 people suffer a heart attack each year in the UK. Heart disease costs the UK economy GBP29 billion a year in healthcare expenditure and lost productivity with more than 69 million work days lost to heart disease in 2004.

Cardiovascular disease (CVD) is still Australia's greatest health problem. It kills more people than any other disease (accounting for 47,637 deaths in 2004) and affected 3.5 million Australians in 2004-05.