Global pharmaceutical company AstraZeneca has announced its drug Brilinta (ticagrelor) in combination with aspirin has met its primary endpoint, a statistically significant reduction in major adverse cardiovascular events, in the Phase III THEMIS trial.
THEMIS is a multi-national, randomised, double blind trial comprised of 19,000 coronary artery disease (CAD) and type 2 diabetes patients who had not had a heart attack prior to registration. The control group were given only aspirin.
Safety results for Brilinta were consistent with the drug’s known safety profile. Full data from the trial will be presented at AstraZeneca’s upcoming medical meeting.
THEMIS co-chair, Université Paris-Diderot professor and Imperial College National Heart and Lung Institute professor Gabriel Steg said: “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.
“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.”
The other trial co-chair, Harvard Medical School professor and Brigham and Women’s Hospital Interventional Cardiovascular Programs executive director Deepak L. Bhatt said: “The THEMIS trial is the largest randomised trial of patients with type-2 diabetes performed to date and was designed to evaluate whether more-intense antiplatelet therapy is a promising approach.
“The results could help us refine our understanding of the role of dual antiplatelet therapy in patients across the atherothrombotic spectrum.”
Brilinta is available as an orodispersible tablet. It is PSY12 receptor antagonist, which works by inhibiting platelet activation.
The drug is approved in combination with acetylsalicylic acid to prevent atherothrombotic events in patients with acute coronary syndromes and a history of myocardial infarction.
It is currently being tested for acute ischaemic stroke and to prevent vaso-occlusive crises in paediatric patients with sickle cell disease.