AstraZeneca Reports Failure in Heart Disease Drug Trial

Brilinta did not outperform clopidogrel in patients with symptomatic peripheral artery disease.

AstraZeneca recently announced their drug Brilinta (ticagrelor) failed in a clinical trial of patients with symptomatic peripheral artery disease.

The drug did not demonstrate benefit over clopidogrel, and did not meet the primary endpoint of the study, according to the company’s press release.

The EUCLID clinical trial to evaluate the drug included 13,855 patients with symptomatic peripheral artery disease, making it the largest cardiovascular outcomes trial to be conducted in this patient group. All patients in the trial were above 50-years-old.

Peripheral artery disease is a clinical manifestation of systemic artherosclerotic vascular disease, and is a common cause of cardiovascular complications such as myocardial infarction and stroke.

Despite serious risk of vascular events, few patients receive the recommended treatment, according to AstraZeneca. There is currently no cure for the disease, and patients are at high risk of cardiovascular morbidity and mortality.

Patients in the trial either received treatment with Brilinta 90-mg tablets twice per day, or clopidogrel 75-mg once per day. The primary endpoint was time to the first occurrence of atherothrombotic events, such as cardiovascular death, heart attack, or stroke.

According to AstraZeneca, Brilinta did not provide more of a clinical benefit than clopidogrel. They also reported that safety data from the trial is consistent with its known profile.

Brilinta is a direct-acting P2Y12 receptor antagonist that inhibits platelet activation, and can reduce the rate of atherothrombotic cardiovascular events in patients with acute coronary syndrome, according to the press release. The drug has already been indicated for use in patients with acute coronary syndrome, non-ST-evlevation myocardial infarction, or ST-elevation myocardial infarction.

A lower dose of the drug, 60-mg, is indicated in patients who have had a heart attack at least 1-year prior with a high risk of experiencing an atherothrombotic event. Full results from the EUCLID study will be presented at the American Heart Association Scientific Sessions, AstraZeneca said.

“The proven benefits of Brilinta in acute coronary syndrome and post-myocardial infarction patients are established and remain unchanged,” said Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AstraZeneca. “We are disappointed that the EUCLID trial results showed Brilinta did not demonstrate a benefit over clopidogrel in this specific symptomatic PAD population.”