PEGASUS-TIMI 54 SUB-ANALYSIS OUTLINES LONG-TERM TOLERABILITY DATA FOR BRILIQUE

AstraZeneca has announced results of a sub-analysis of the PEGASUS-TIMI 54 study, which evaluated reasons and rates for discontinuation of BRILINTA^®/BRILIQUE^TM (ticagrelor) efficacy in patients with a history of myocardial infarction (MI) (one to three years prior to study randomization) and the efficacy in those patients who stayed on therapy. The data were presented during a Late-Breaking Clinical Trials session November 10 at the 2015 American Heart Association (AHA) Scientific Sessions.

The pooled analysis of the results showed that in patients who stayed on therapy, ticagrelor reduced the rate of the composite efficacy endpoint of cardiovascular (CV) death, MI, or stroke at three years (HR 0.79, 95% CI 0.70-0.88), consistent with the results of the overall population of the PEGASUS study. Discontinuation resulting from an Adverse Event (AE) was 8.9% in the placebo arm, 19% and 16.4% in the 90 mg and 60 mg arms, respectively, and was most frequently due to bleeding and dyspnea.

Marc Bonaca, MD, Thrombolysis in Myocardial Infarction [TIMI] Study Group, Brigham and Women’s Hospital, Boston, MA and lead investigator for the sub-analysis study, said: “This analysis pointed to important patterns with regards to common AEs associated with ticagrelor in the context of clinical benefit. Physicians must consider the overall risks, including higher rates of bleeding and dyspnea in the first year. For patients at increased risk for recurrent cardiovascular events in the long-term, ticagrelor can provide an important benefit.”

"This sub-group analysis provides additional insight into the clinical profile of ticagrelor and reinforces its role in the reduction of the composite of CV death, MI, and stroke for these patients studied in PEGASUS,” Bonaca added.

The PEGASUS-TIMI 54 study investigated the efficacy and safety of ticagrelor at both 60 mg and 90 mg twice daily, plus low dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of atherothrombotic events in patients >50 years of age who had suffered a heart attack one to three years prior to study enrollment and had one additional risk factor for thrombotic CV events.

Ticagrelor is currently under review in the EU for use in the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack within one to three years.

Ticagrelor has been studied in multiple clinical trials, including the PLATO and PEGASUS trials. In PLATO and PEGASUS alone, nearly 40,000 patients have been studied with ticagrelor.

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NOTES TO EDITORS

About PEGASUS-TIMI 54

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is AstraZeneca’s largest outcomes trial with more than 21,000 patients from over 1,100 sites in 31 countries. The study assessed ticagrelor tablets at either 60 mg twice daily or 90 mg twice daily plus once daily low-dose aspirin compared to placebo plus once daily low-dose aspirin for the secondary prevention of atherothrombotic events in patients ≥ 50 years of age who had experienced a heart attack one to three years prior to study start and had at least 1 risk factor for thrombotic cardiovascular events ( age ≥ 65 years, Diabetes mellitus requiring medication, at least one other prior MI, evidence of multivessel coronary artery disease or a creatinine clearance < 60 ml/min). The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke at 36 months. Patients were treated for at least 12 months and up to 48 months with a median follow-up time of 33 months. Only the 60 mg dose is approved for use in patients with a history of MI beyond 12 months. The study was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).

BRILINTA and BRILIQUE are registered trademarks of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

Contact:

Petra Eurenius, External Communications Manager, AstraZeneca Nordic-Baltic. Tel: +46 709 186562