Sanofi’s alirocumab improves cardiovascular event rate over statins

The PCSK9 inhibitor, which lowered blood lipids by 40-60% in previous trails, reduced the  risk  of MACE by 15% and was associated with a 29% lower risk of death overall in a patient population with acute coronary syndrome. The effect of Praluent on cardiovascular morbidity and mortality, however, has not been determined. 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. The trial was designed to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of Praluent (75 mg and 150 mg). There was no difference in neurocognitive events (1.5% Praluent; 1.8% placebo) or new-onset diabetes (9.6% Praluent; 10.1% placebo).

Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which lowers LDL-C levels in the blood. Pradulent is alsready approved in the US and the EU.

In the U., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease  who require additional lowering of LDL-C. In the EU, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (or mixed dyslipidemia as an adjunct to diet: in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach approrialte LDL-C levels with statin monotherapy or in which statin therapy is contraindicated

Results were presented at the American College of Cardiology's 67th Annual Scientific Session in Orlando.