AstraZeneca’s ticagrelor receives Class I recommendation from ESC

AstraZenecaAug 29 2012

AstraZeneca today announced that ticagrelor, an oral antiplatelet medicine, received a Class I recommendation from the European Society of Cardiology (ESC) in the revised "Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with Persistent ST-Segment Elevation (STEMI)" guidelines. Ticagrelor is known as BRILIQUE in the European Union and BRILINTA elsewhere.    

For primary percutaneous coronary intervention (PCI), the guidelines now recommend ticagrelor with no restrictions for STEMI patients (Class I; LOE B). Prasugrel, (Class I; LOE B), is recommended only for clopidogrel-naïve patients with no prior history of stroke/TIA and aged <75 years. Clopidogrel is recommended when prasugrel or ticagrelor are either not available or contraindicated. All of these recommendations are in combination with aspirin.

Ticagrelor plus aspirin, or prasugrel plus aspirin, are recommended (over clopidogrel plus aspirin) in patients treated with PCI (Class I: LOE A). Treatment with ticagrelor is recommended for up to 12 months. In addition, the guidelines recommend antiplatelet therapy with low dose aspirin after STEMI indefinitely.

With this addition, ticagrelor is now recognised as a standard therapy for acute coronary syndromes (ACS) patients within a total of ten sets of US and global guidelines, including the ESC's 2011 Guidelines for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation and 2010 Guidelines for Myocardial Revascularisation.

"The inclusion of ticagrelor in the ESC STEMI guidelines is recognition by the medical community of the established role of BRILINTA in contemporary standard-of-care ACS management. These guideline updates underscore a growing acceptance amongst the medical community of the benefits of ticagrelor (plus low dose aspirin) for a broad range of ACS patients," said Dr. James Ferguson, VP Global Medical Affairs, CV, AstraZeneca. "The recommendation from the ESC is another important step toward improving access for ACS patients to ticagrelor in Europe, where ACS affects an estimated 1.4 million people every year - more than all cancers combined."

The inclusion of ticagrelor in the new ESC guidelines were based on data from PLATO (A Study of PLATelet Inhibition and Patient Outcomes), which demonstrated that treatment with ticagrelor plus aspirin led to a greater reduction in the primary end point - a composite of CV death, myocardial infarction (MI), or stroke - compared to clopidogrel plus aspirin [9.8% vs. 11.7% at 12 months; 16% relative risk reduction (RRR); 95% CI, 0.77 to 0.92]. The difference in treatments was driven by CV death and MI with no difference in stroke. The PLATO study also demonstrated that treatment with ticagrelor for 12 months was associated with a 21% RRR in CV death [4% vs. 5.1%; 1.1% absolute risk reduction (ARR)] and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% ARR). With ticagrelor, there was no increase in overall major/fatal bleeding over the course of one year of treatment (11.6% for ticagrelor versus 11.2% for clopidogrel); however, non-CABG major bleeding was more common with ticagrelor versus clopidogrel (4.5% vs. 3.8).