Myocardial infarction: PEGASUS-TIMI 54 sub-analysis outlines long-term tolerability data for BRILINTA

AstraZeneca has announced results of a sub-analysis of the PEGASUS-TIMI 54 study, which evaluated reasons and rates for discontinuation of BRILINTA® (ticagrelor) 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 at the 2015 American Heart Association (AHA) Scientific Sessions.

The pooled analysis of the results showed that in patients who stayed on therapy, BRILINTA 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 BRILINTA 90 mg and 60 mg arms, respectively, and was most frequently due to bleeding and dyspnea. Rates of AEs leading to discontinuation were highest in the first year at 16% in the 90 mg arm, 13% in the 60 mg arm, and 6% in the placebo arm. In those patients who stayed on therapy, discontinuation rates over the subsequent two years were 6.5% in the 90 mg arm, 6.0% in the 60 mg arm, 4.6% in the placebo arm.

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 particularly within 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.

Steven Zelenkofske, D.O., FACC, Vice President, US Medical Affairs, AstraZeneca said: "We welcome the results of this sub-analysis, which lends insights regarding the tolerability and efficacy of BRILINTA long-term during a time when questions remain regarding the appropriate length of dual antiplatelet therapy."

On September 3, 2015, the US Food and Drug Administration (FDA) approved a new 60-mg tablet dosage strength for BRILINTA to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

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. Only the 60-mg dosage strength is approved for use in patients with a history of MI. BRILINTA 60 mg tablets are now available in US pharmacies.

BRILINTA 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 BRILINTA.

For patients who have been prescribed BRILINTA, AstraZeneca offers the BRILINTA Patient Support Service (BPSS) tool that provides resources and support to help patients and caregivers from hospital discharge throughout the ACS treatment journey. To help loved ones, the program offers important patient education and coaching in addition to savings offers, refill reminders, personal pharmacy locator, co-pay calculator, and coverage verification and information. To enroll in BPSS, call 1-888-512-7454 or enroll online at www.BRILINTA.com. Health care professionals can visit www.BRILINTAtouchpoints.com.