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New oral antiplatelet agent ticagrelor first to show reduction in cardiovascular death

August 31st, 2009

The presentation of the PLATO (A Study of Platelet Inhibition and Patient Outcomes), showed that ticagrelor (Brilinta®) reduced the rate of cardiovascular (CV) events (CV death, myocardial infarction or stroke) from 11.7% to 9.8% compared clopidogrel (Plavix®) XX% (p<0.001, rrr = 16%), without an increase in major bleeding. this efficacy endpoint was driven by a statistically significant reduction in both cv death and myocardial infarction (mi) with no difference in stroke. ticagrelor is the first antiplatelet agent to demonstrate a reduction in cv death across all major acute coronary syndromes (acs) patient types.

For every 1,000 patients admitted to the hospital because of an ACS event, use of ticagrelor instead of
clopidogrel, for up to one year, led to 14 fewer deaths, or 11 fewer MI's, or 8 fewer cases of stent thrombosis,
without an increase in major bleeds. In the PLATO study, the reduction in risk of cardiovascular events
appears early and the benefit over clopidogrel grows with time. Ticagrelor demonstrated a consistent benefit
across multiple secondary efficacy endpoints including CV death and total mortality; myocardial infarction; the
composite of myocardial infarction, stroke, and total mortality; and a composite of cardiovascular death,
myocardial infarction, stroke, transient ischemic attack, recurrent cardiac ischemia, severe recurrent cardiac
ischemia, and other arterial thrombotic events.

"Ticagrelor is the first antiplatelet therapy to achieve a significant reduction in CV mortality in ACS patients
versus clopidogrel and perhaps most importantly without an increase in major bleeding," commented
Professor Lars Wallentin, co-chair of the PLATO Executive Committee. "PLATO has redefined what is
possible in the prevention of recurrent events in patients with acute coronary syndromes."

The PLATO study confirmed the clinical safety profile of previous ticagrelor studies by showing an efficacy
advantage without an increase in major bleeding. Across all the important patient subgroups (e.g. gender,
weight, history of stroke/TIA) in PLATO, ticagrelor showed no difference versus clopidogrel in the incidence of
major bleeding. When minor bleeding was added, ticagelor showed a small increase in PLATO defined major
plus minor bleeding versus clopidogrel. At continuous ECG monitoring wile in hospital, but not at later followup
in the outpatient setting, pauses in the heart rhythm were seen more frequent with ticagrelor. However such
pauses were not associated with any symptoms or clinical consequences for the patient. Transient symptoms
of dyspnoea were reported more often by patients on ticarelor but only one in 100 ticagrelor treated patients
overall stopped taking study medication due to dyspnoea.

PLATO was a head-to-head outcomes study of ticagrelor plus aspirin versus the active comparator,
clopidogrel plus aspirin, and was designed to establish whether ticagrelor could achieve meaningful
cardiovascular endpoints in ACS patients. 18,624 patients at 893 sites in 43 countries across all continents
were sucessfully recruited. All patients were admitted to hospital because of acute coronary syndrome, one
third with ST-elevation myocardial infarction and two thrirds without ST-elevation. Shortly after admission to
hospital, the patients started their long-term anti-platelet treatment with either ticagrelor (90 mg twice daily) or
clopidogrel (75 mg daily) in a randomized, double-blind fashion for 6 - 12 months. The PLATO study was led
by the Executive Committee co-chairs, Professor Lars Wallentin, Sweden (Uppsala Clinical Research Center)
and Professor Robert Harrington, USA (Duke Clinical Research Institute).

The PLATO study was sponsored by AstraZeneca which has developed and manufactures ticagrelor
(Brilinta®). AstraZeneca is a major international healthcare business engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services.

Source: European Society of Cardiology

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