Sanofi and Regeneron Pharmaceuticals have completed enrollment in the global phase three, Odyssey Outcomes trial for patients suffering from acute coronary syndrome (ACS)
The Odyssey Outcomes trial determines whether the addition of Praluent to intensive statin therapy reduces major adverse cardiac events among patients who had previously experienced an acute coronary syndrome (ACS), such as a heart attack or unstable angina.
The primary endpoint of the trial evaluates the time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalisation for unstable angina or fatal and non-fatal ischemic stroke.
Sanofi said atients with recent ACS were selected as the study population because they face a higher risk of recurrent events than patients with stable cardiovascular disease.
Praluent is currently approved in the US and EU to reduce LDL cholesterol in some patients with significant unmet need, including those with established cardiovascular disease, or an inherited form of high cholesterol.
In completed trials, Praluent reduced LDL cholesterol by up to an additional 62% versus placebo.
The global Odyssey programme includes 16 phase three trials conducted at more than 2,000 study centers around the world and once complete will evaluate more than 25,000 patients.
The effect of Praluent on CV morbidity and mortality has not been determined.
The Odyssey Outcomes trial design was published in the American Heart Journal in November 2014.