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Regeneron’s anti-cholesterol drug Praluent reduces death risk in trial

PBR Staff Writer Published 12 March 2018

Praluent (alirocumab), an anti-cholesterol drug being developed by Regeneron Pharmaceuticals and Sanofi, has succeeded in the Odyssey Outcomes trial by decreasing the risk of death and heart attack in high-risk patients.

The Odyssey Outcomes trial, which met its primary endpoint, was held in nearly 19,000 patients who had a recent acute coronary syndrome (ACS) event, such as a heart attack.

Praluent was shown to have cut down the overall risk of major adverse cardiovascular events (MACE) by 15%, which is the primary endpoint of the trial.

High-risk patients who were subjected to Praluent injection in combination with maximally-tolerated statins had significantly lesser major adverse cardiovascular events compared to patients treated on only maximally-tolerated statins.

The trial evaluated the effect of Praluent on the occurrence of MACE in patients who had suffered an ACS event 1-12 months before enrolling in the study, and who were already subjected to maximally-tolerated statins.

Patients were randomized equally to be treated either by Praluent injection or a placebo, with the treatment period lasting an average of 2.8 years.

Regeneron president and chief scientific officer George Yancopoulos said: “This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline.

"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options because of their increased risk of another event.

“In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk."

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor. This results in an increased number of available LDL receptors on the surface of liver cells, which reduces the levels of LDL-C in the blood.

Praluent is yet to be approved by any regulatory agency, when it comes to its use in reducing the risk of MACE.

However, the drug had been approved in the US as an adjunct to diet and maximally-tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who need further lowering of LDL-C.

In the European Union, Praluent was approved for treating adults with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet with certain conditions attached.

Image: The Odyssey Outcomes trial, which evaluated Praluent, met its primary endpoint. Photo: courtesy of jk1991/