Phase III PLATO study proves that ticagrelor is more effective than clopidogrel

Sep 25 2009

New data from the phase III PLATO study showed that ticagrelor (BRILINTA((TM))) provided greater reduction of cardiovascular (CV) events (composite of CV death, heart attack and stroke) than clopidogrel (9.02% vs. 10.65%,>

Additional findings from this PLATO invasive sub-analysis showed that treatment with ticagrelor, compared to clopidogrel, demonstrated an effect consistent with the results for the entire invasive subgroup across the multiple secondary efficacy endpoints. The effect was seen regardless of whether a standard 300 mg loading dose of clopidogrel was given, or an additional loading dose of clopidogrel (e.g. 600 mg) was given. Specifically, results in this subgroup analysis indicated treatment with ticagrelor:

• Reduced CV death 3.4% vs. 4.3%>
• Reduced myocardial infarction (heart attack, MI) 5.3% vs. 6.6%>
• Reduced definite stent thrombosis 1.0% vs. 1.6%>
• Reduced total mortality 3.9% vs. 5.1%>

"The majority of patients rushed to the hospital with severe chest pain or heart attacks will have an invasive procedure," said Christopher Cannon, M.D., PLATO Executive Committee member, a cardiologist at Brigham and Women's Hospital in Boston. "Doctors need to make quick decisions about antiplatelet therapy for patients who are sent for cardiac catheterization and may need angioplasty or surgery. In this study population, ticagrelor led to fewer heart attacks and deaths without a significant increase in major bleeding versus clopidogrel."

Similar to the overall PLATO findings, Dyspnoea (shortness of breath) was more common among patients on ticagrelor but less than 1% discontinued ticagrelor treatment in the sub-analysis because of dyspnoea.

The PLATO study was designed to reflect how patients with ACS are currently managed in clinical practice, by including patients who underwent invasive procedures and those who were managed with medication only.

Last month, the primary results from PLATO were presented at the European Society of Cardiology and simultaneously published in The New England Journal of Medicine in August 2009.

AstraZeneca remains on track to submit BRILINTA to regulatory authorities in the fourth quarter of this year.

Source: http://www.astrazeneca-us.com