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.
Prasugrel and clopidogrel are both antiplatelet drugs. They prevent platelets from clumping or sticking together, which can cause formation of blood clots and lead to heart attack or stroke.
Dr Tony Gershlick, leading UK Consultant Cardiologist at the Glenfield Hospital, Leicester, welcomes the data and comments: "Prasugrel appears from this study to have the potential to move the management of patients with ACS forward, improving on the current standard of care for these high risk patients."
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- a group of conditions known as Acute Coronary Syndrome (ACS). These patients had undergone a procedure called angioplasty or Percutaneous Coronary Intervention (PCI).
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- that's one heart attack every two minutes and in the UK there are approximately 2.6 million people who have had either a heart attack or angina (stable or unstable). 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.
Dr Robert Storey, Senior Lecturer and Honorary Consultant in Cardiology, Cardiovascular Research Unit, University of Sheffield, commented: "Heart attacks and unstable angina are alarming conditions for people that put their lives at risk and can cause enduring ill-health. Cardiologists have been striving to improve the treatment for these conditions but need better tools in order to treat the clots in the arteries of the heart that cause most cases of ACS. TRITON shows that more effective drugs that help treat these clots may mean better outcomes for these people in the future."
Patients who participated in the TRITON study were randomly chosen to receive prasugrel (60 mg loading dose / 10 mg maintenance dose) plus aspirin or clopidogrel (300 mg loading dose / 75 mg maintenance dose) plus aspirin for 12 months. The doses for prasugrel were based on earlier study findings and for clopidogrel were standard approved doses.
As antiplatelet drugs help prevent blood from clotting too much, they can cause excess bleeding. The beneficial effects of the investigational drug prasugrel were associated with a higher risk of major bleeding (2.4% and 1.8% major for prasugrel and clopidogrel respectively).
The TRITON data will be submitted to regulatory authorities as part of the drug's approval process.
About TRITON TIMI-38
The TRITON TIMI-38 clinical trial has been conducted in conjunction with the TIMI Study Group at Harvard Medical School and Brigham and Women's Hospital in Boston. The Phase III study looked at the effectiveness and safety of prasugrel compared with clopidogrel in reducing ischemic events such as heart attacks, stroke and death in patients with acute coronary syndrome undergoing PCI, a procedure to open blockages in heart arteries that includes the use of coronary stents.
Source: Eli Lilly and Company
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