Sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial of Brilinta demonstrated a 29% risk reduction in CV death.- AstraZeneca.

AstraZeneca announced results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29% risk reduction in CV death (p=0.0041) from treatment with Brilinta (ticagrelor) 60mg twice daily, versus placebo, in patients taking low-dose aspirin but still at high risk of an atherothrombotic event, a major cause of acute coronary syndrome and CV death. Patients received Brilinta within two years of having a heart attack (myocardial infarction, MI) or within one year of stopping anti-platelet treatment with an adenosine diphosphate (ADP) inhibitor.

The latest results highlight a potential protective CV benefit associated with longer-term treatment, versus the standard 12-month post-event treatment period, with Brilinta 60mg, and are due to be presented in full at the ESC Congress in Barcelona, Spain. The favourable benefit-risk ratio for extended dual anti-platelet treatment with Brilinta 60mg was suggested earlier in the PEGASUS trial that provided the data supporting the European Medicines Agency’s approval of Brilinta in the post-MI indication.

Mikael Dellborg, Professor of Cardiology at the University of Gothenburg and member of the Steering Committee of the PEGASUS-TIMI 54 trial, said: “The conclusion for both clinicians and patients at high-risk of CV death post-MI is clear: Treatment with Brilinta 60mg, either as continuation therapy after the initial 12 month post-event period, or with as limited interruption as possible, is associated with a clear and favourable benefit-risk ratio for this population of patients. This new insight is potentially practice-changing, as while more than seven million people worldwide suffer a heart attack each year, we know that fewer than half receive adequate long-term treatment to reduce their risk of further CV events.”

The sub-analysis of PEGASUS-TIMI 54 data also showed a risk reduction of 20% in all causes of death, and 20% in the composite of CV death, MI or stroke. As expected, major bleeding rates were consistent with the known safety profile of Brilinta.