Crucial questions remain
The maker of ticagrelor has released top-line results from the phase 3 trial known as THEMIS.
AstraZeneca announced that THEMIS met its primary endpoint of reduction of major adverse cardiovascular events (MACE) among patients with coronary artery disease (CAD) and type 2 diabetes with no history of heart attack or stroke. (MACE is a composite of cardiovascular death, heart attack, and stroke.)
The trial (NCT01991795) explored these risks by comparing ticagrelor (Brilinta) plus aspirin versus aspirin alone. The oral, reversibly binding, direct-acting P2Y12 receptor antagonist is currently indicated for reducing MACE among patients with acute coronary syndrome or a history of MI. According to the press release, the multinational, randomized, double-blind trial is exploring the use of ticagrelor/aspirin among patients with CAD and type 2 diabetes because of this population’s high risk and the lack of treatment options.
Gabriel Steg, MD, THEMIS cochair and professor at Université Paris–Diderot, said in the release that “patients who have both stable coronary artery disease and diabetes are a sizable 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.” He added that the full results from the THEMIS trial will be presented later this year.
Ticagrelor comes with risks of significant and sometimes fatal bleeding; as such it is contraindicated for patients with pathological bleeding risk or history of intracranial hemorrhage. Its use is also discouraged among patients with severe hepatic impairment and in patients who are breastfeeding. Although usually self-limiting when related to ticagrelor use, dyspnea was reported in about 14% of patients taking the drug. Dyspnea and bleeding were among the most common adverse reactions seen with ticagrelor.