PEGASUS BRILINTA TRIAL

Other adverse events were relatively balanced across the 3 arms of the trial. At 3 years, dyspnea rates were 6.5%, 4.6%, and 0.8% and bleeding rates were 7.8%, 6.2%, and 1.5% in the 90-mg bid ticagrelor, 60-mg bid ticagrelor, and placebo groups, respectively. Much of the difference in adverse event-related discontinuations was the result of higher rates of dyspnea and bleeding with ticagrelor. Rates remained higher with ticagrelor in the second and third years among patients who tolerated the first year of treatment, but the disparity was much smaller (6.5% and 6.0% vs 4.5% P <. When looking specifically at drug discontinuation due to adverse events, rates for the higher and lower doses of ticagrelor were elevated compared with placebo in the first year (16% and 13% vs 6%). Still, the risks of discontinuation remained higher with ticagrelor. Those numbers fell considerably in the second and third years, when 564 and 632 patients dropped out in the 2 ticagrelor groups and 588 stopped treatment in the placebo group. In the first year, 1,669 and 1,367 patients discontinued treatment for any reason in the 90-mg and 60-mg bid ticagrelor groups compared with 908 in the placebo group. Most stoppages were due to adverse events. Overall, premature discontinuation at 3 years was higher with the 90-mg and 60-mg bid doses of ticagrelor (32% and 29%, respectively) than with placebo (21%). All received low-dose aspirin in addition to their assigned study drug or placebo. The researchers took a closer look at treatment discontinuations in the trial, which included 21,162 patients who were stable 1 to 3 years after an MI. “And these data underscore the need for patient counseling when initiating antithrombotic therapies in order to maximize adherence and improve outcomes.” “Non-serious bleeding and other adverse events have very important consequences, including discontinuation of therapy,” Bonaca said.

PEGASUS BRILINTA TRIAL

Moreover, an on-treatment analysis showed that both the 90-mg and 60-mg twice-daily doses of ticagrelor (Brilinta AstraZeneca) reduced the risk of cardiovascular death, MI, or stroke (primary composite endpoint) by a relative 20% through 3 years of follow-up, a slightly larger magnitude of benefit compared with the intention-to-treat analysis from the main trial results. Bleeds were generally mild or required medical attention without rising to the threshold for TIMI minor or major bleeding, Marc Bonaca, MD, MPH, of Brigham and Women’s Hospital (Boston, MA), reported here at the American Heart Association 2015 Scientific Sessions.Īmong patients who tolerated therapy for the first year, rates of discontinuation related to adverse events were relatively low at about 3% per year going forward. ORLANDO, FL-The higher rate of premature discontinuation of ticagrelor vs placebo in the PEGASUS-TIMI 54 trial of stable outpatients with prior MI is attributed largely to more frequent dyspnea and bleeding, a new study shows.Įven so, dyspnea was considered non-serious in more than 95% of cases and rated as mild-to-moderate in intensity by more than 80% of affected patients.

Pegasus brilinta