Published: Tue, March 13, 2018
Medicine | By Brett Sutton

Anti-cholesterol drug Praluent cuts death risk

Anti-cholesterol drug Praluent cuts death risk

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 trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg).

Praluent is part of a relatively new class of drugs called PCSK9 inhibitors which can dramatically lower cholesterol, and may work even better than statins, the traditional first line of treatment. The 3-year study found that patients taking alirocumab were 15% less likely to experience a heart attack, stroke, or hospitalization compared with those taking placebo.

ODYSSEY OUTCOMES results were presented at the American College of Cardiology's 67th Annual Scientific Session in Orlando, Florida. For those in the alirocumab treatment arm, approximately 75% of patient time was on the 75 mg dose.

Alongside the data the companies announced plans to boost the affordability and accessibility of Praluent for patients most in need, by offering a reduced net price to United States payers that agree to reduce "burdensome access barriers" for high-risk patients.

Sanofi and Regeneron have pledged to make Praluent more accessible to patients as data show that the drug significantly cut the risk of cardiovascular events in high-risk patients.

In a subgroup analysis of highest-risk patients - those with "bad" LDL cholesterol of 100 or above despite maximum statin therapy - Praluent significantly reduced all-cause death risk by 29 percent and risk of the adverse event composite by 24 percent.

Patients receiving Praluent also experienced a statistically valid reduction in the overall risk of death (hazard ratio = 0.85) versus control.

"Inventing innovative medicines only matters if the people who need these products are able to access them-and that is unfortunately not the case with Praluent today", said Leonard S. Schleifer, MD, PhD, President and Chief Executive Officer of Regeneron. In the long-term trail patients on high-dose statin therapy had been randomised 1:1 for Pradulent combination and statin monotherapy and were treated for an average (median) of 2.8 years. Approximately 90% of patients were on a high-intensity statin.

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor.

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