Annual Congress of American College of Cardiology 2014

ACC 2014: Bococizumab: Phase II data in statin-treated patients with hypercholesterolaemia

Bococizumab (RN316/PF-04950615) is a novel humanised PCSK9 monoclonal antibody. This 24-week, multicentre, randomised, double-blind, placebo-controlled trial evaluated LDL-C lowering effects of bococizumab, administered every 2 weeks or monthly (i.e. 4 weeks) in statin-treated patients aged ≥18 yrs with hypercholesterolaemia (LDL-C ≥80 mg/dL or 2.1 mmol/L)….

ACC 2014 Latebreaker: GAUSS-2: Evolocumab addresses unmet needs in statin intolerance

Muscle-related symptoms (often referred to as myopathy or myalgia) are the main side effect consistently associated with statins, affecting about 5-10% of patients in clinical trials, but up to 20% of patients in the real-world clinical setting. Statin intolerance due to muscle symptoms is the…

ACC 2014 BMS-962476: First in man data

Trial BMS-962476: First in man data Aim To assess the effects of BMS-962476, a novel anti-PCSK9 agent Study design A randomised, double-blind, placebo-controlled, sequential panel, partial overlapping single ascending dose study Patient population Healthy subjects on diet with LDL-C levels >130 (3.4 mmol/L) and >190…

ACC 2014 Latebreaker: LAPLACE-2: Evolocumab effective in patients on high and moderate-intensity statins

The recent ACC/AHA guidelines have focused on the intensity of statin therapy for lowering LDL-C.  Consequently, the LAPLACE-2 (Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy – 2) phase III trial assessed the efficacy of evolocumab in patients with hypercholesterolaemia…

ACC 2014 MENDEL-2: More evidence for evolocumab monotherapy in treatment-naive patients

Statins are indisputably the cornerstone of lipid-lowering therapy for prevention of cardiovascular disease. However, it is recognised that certain subgroups of patients may be unable to tolerate a statin, or will be unable to achieve LDL-C goal despite statin therapy. Although ezetimibe is a second…

ACC 2014 ODYSSEY MONO: First Phase III data for alirocumab suggests potential as an alternative to statins in hypercholesterolaemia

In this first report of Phase III data, the PCSK9 monoclonal antibody, alirocumab, demonstrated superior LDL-C lowering compared with ezetimibe over 24 weeks, suggesting potential as a treatment alternative to statin therapy in patients with hypercholesterolaemia. ODYSSEY MONO was a randomised, double-blind, double-dummy study in…

ACC 2014 DESCARTES: Durable LDL-C lowering with evolocumab

DESCARTES (Durable Effect of PCSK9 Antibody Compared with Placebo Study) showed substantial and sustained LDL-C lowering in patients with varying levels of cardiovascular risk. DESCARTES  was a randomized, double-blind, placebo-controlled, phase 3 trial which compared evolocumab with placebo in patients with hyperlipidemia enrolled by 88…

ACC 2014 RUTHERFORD-2: Evolocumab in heterozygous FH

Despite potent statin therapy, and the use of additional lipid-lowering treatment, most patients with heterozygous familial hypercholesterolaemia (FH) fail to achieve LDL-C targets. Previously the RUTHERFORD study showed that AMG 145 (evolocumab) administered every 4 weeks resulted in substantial reductions in LDL-C in this patient…

ACC 2014 Alirocumab: One-year data in heterozygous FH

Treatment with the PCSK9 monoclonal antibody alirocumab 150 mg every 2 weeks, in addition to statin±ezetimibe,  resulted in substantial LDL-C reductions in patients with heterozygous FH, consistent with phase II trial data, which were sustained over 12 months. These data extend the evidence for the…

New ACC/AHA guidelines for cholesterol management: View from the Editors