Statins are first-line therapy for hypercholesterolemia. However, many patients are not able to achieve their goals despite the maximal dose or because of adverse effects. Monoclonal antibody RN316 binds to PCSK9 increasing LDL clearance. This trial randomized 135 patients with an average LDL of 120 mg/dl despite the maximal dose statins to receive 4 different dosage regimens of endovenous RN316 every 4 weeks for 12 weeks. In the treatment group, LDL level saw a significant reduction of 20-60%, treatment intolerance reached 29%, mostly in the highest doses.
Conclusion: RN316 significantly reduces LDL levels in patients with maximal doses of statins.
Comment: though its effects seem promising, we need studies to show a reduction in clinical events. Endovenous administration and 29% of adverse effects suggest adherence to treatment.
Barry Gumbiner
2012-11-05
Original title: Effects of 12 Weeks of Treatment with RN316 (PF-04950615), a Humanized IgG2Δa Monoclonal Antibody Binding Proprotein Convertase Subtilisin Kexin Type 9, in Hypercholesterolemic Subjects on High and Maximal Dose Statins.