October 2, 2012 — AstraZeneca has announced the results from a sub-analysis of PLATO that evaluated the effects of age on clinical outcomes in patients with acute coronary syndrome (ACS). Results of the analysis suggest the overall findings from the PLATO study of a greater reduction in thrombotic cardiovascular (CV) events with Brilinta (ticagrelor) tablets plus aspirin compared to clopidogrel plus aspirin were consistent regardless of age. The PLATO age sub-analysis is important because approximately 33 percent of all ACS episodes occur in patients over 75 years of age. These data are now published in the September print and online issues of Circulation: Cardiovascular Quality and Outcomes, and were presented at the American College of Cardiology 2011 meeting.
“Elderly patients with ACS are at high risk for recurrent ischemic events and treatment-related complications,” said James Ferguson, M.D., executive director of medical affairs and strategic development, and vice president for global medical affairs at AstraZeneca. “This PLATO sub-analysis suggests that the clinical benefits of Brilinta vs. clopidogrel on thrombotic CV events were not significantly affected by age, and were similar in patients 75 years of age and older and younger patients.”
Brilinta is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In PLATO, Brilinta has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI) or stroke compared to clopidogrel. In PLATO, the difference between treatments was driven by CV death and MI, with no difference in stroke. In patients treated with percutaneous coronary intervention (PCI), Brilinta reduces the rate of stent thrombosis.
Brilinta has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreases the effectiveness of Brilinta. Patients are urged to avoid maintaining doses of aspirin above 100 mg daily.
Specific data from this sub-analysis showed:
- In PLATO, higher overall rate of thrombotic CV events (adjusted hazard ratio [HR], 1.48 [95% CI, 1.32-1.66]) were associated in patients ?75 years (n=2,878); Higher rates of PLATO-defined Overall Major Bleeding were also associated with this patient population (adjusted HR, 1.11 [95% CI, 0.97-1.26]).
- The effects of Brilinta compared to clopidogrel were consistent for thrombotic CV events, regardless of age. Thus, there was a similar reduction in the primary composite end point for patients aged ? 75 years of age (adjusted HR, 0.89 [95% CI, 0.74 -1.08]) and for patients < 75 years of age (adjusted HR, 0.84 [95% CI, 0.75 - 0.93]) (interaction p= 0.56).
- There was no significant interaction between age and the effects of treatment on Overall Major Bleeding and Non-CABG Major Bleeding. For PLATO-defined Overall Major Bleeding the adjusted HRs for Brilinta vs. clopidogrel were 1.02 (95% CI, 0.82–1.27) and 1.04 (95% CI, 0.94–1.15) for patients aged ?75 years and in younger patients, respectively (interaction P=0.89). For Non-CABG related Major Bleeding events, the adjusted HRs for Brilinta vs. clopidogrel were 1.18 (95% CI, 0.87–1.59) in patients aged ?75 years and 1.19 (95% CI, 0.99–1.43) in younger patients. (interaction P=0.96).
- Dyspnea and ventricular pauses were more common with Brilinta than with clopidogrel treatment. With regards to dyspnea, rates were higher in elderly vs. younger patients in both treatment groups. In this analysis, dyspnea showed no evidence of an age by treatment interaction (P=0.21). Similarly, ventricular pauses showed no evidence of an age-by treatment interaction.
For more information: www.astrazeneca-us.com