Ticagrelor Reduces Cardiovascular Events in Type 2 Diabetes Patients

According to findings from the Phase III THEMIS trial, patients with type 2 diabetes who took ticagrelor in conjunction with aspirin significantly reduced their risk of adverse cardiovascular outcomes compared to patients taking aspirin alone.

THEMIS measured the efficacy of AstraZeneca’s Brilinta.

THEMIS

The randomized, double-blinded THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) trial, sponsored by AstraZeneca, included over 19,000 patients with coronary artery disease and type 2 diabetes who had no history of myocardial infarction or stroke. The trial began in 2013. The primary outcome was the first occurrence of any event from the composite of cardiovascular death, myocardial infarction, or stroke. Secondary outcomes included prevention of cardiovascular death, myocardial infarction, ischemic stroke, and all-cause death.

According to a press release, the trial’s preliminary safety results were consistent with Brilinta’s safety profile. The full data has yet to be released but will be shared at an upcoming medical meeting.

“The THEMIS trial is the largest [randomized] trial of patients with type-2 diabetes performed to date and was designed to evaluate whether more-intense antiplatelet therapy is a promising approach,” said Deepak L. Bhatt, MD, MPH, THEMIS co-chair and executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and a Professor at Harvard Medical School. “The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.”

“Patients who have both stable coronary artery disease and diabetes are a sizeable group which remains at particularly high risk of major adverse cardiac events,” said Gabriel Steg, MD, THEMIS co-chair and professor at Université Paris-Diderot, Paris as well as at the National Heart and Lung Institute, Imperial College, London. “The optimal long-term antiplatelet therapy in that group is not fully established. We look forward to presenting the full results from the THEMIS trial later this year.”