The aim of this study was to evaluate treatment with alirocumab a monoclonal antibody against PCSK9 receptor, compared with placebo in patients with heterozygous familial hypercholesterolemia or high cardiovascular risk who were at the maximum tolerated dose of statins and LDL >70 mg/dl. A total of 2341 patients randomized to 150 mg alirocumab administered subcutaneously every 2 weeks for the same patients (n = 1553) or subcutaneous injection of placebo (n = 788) were included. All were receiving concomitant therapy with statins.
At 24 weeks a decrease of 61% in LDL at alirocumab versus 0.8% with placebo (p <0.0001) was observed. HDL significantly increased too. The combined clinical events (death from coronary heart disease, myocardial infarction, stroke or unstable angina requiring hospitalization) was 1.7% for alirocumab versus 3.3% for placebo (p = 0.02).
Conclusion
In patients with heterozygous familial hypercholesterolemia or high cardiovascular risk, alirocumab resulted in a reduction of LDL compared with placebo.
Jennifer G. Robinson
2015-03-17
Original title: Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events.