Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events

Abstract

During approximately 1 year of therapy, the use of evolocumab plus standard therapy, as compared with standard therapy alone, significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events in a prespecified but exploratory analysis. (Funded by Amgen; OSLER-1 and OSLER-2 ClinicalTrials.gov numbers, NCT01439880 and NCT01854918.).

Cost‐Effectiveness ofLDL‐C Lowering With Evolocumab in Patients With High Cardiovascular Risk in the United States

“…Notably, the scenario using a post‐hoc cardiovascular‐event reduction from a randomized open‐label extension study9 of evolocumab found a lower ICER than the base case (which used the CTTC rate ratios3). …”

Lipoprotein(a) Interactions With Low‐Density Lipoprotein Cholesterol and Other Cardiovascular Risk Factors in Premature Acute Coronary Syndrome (ACS)

“…Future trials targeting individuals with high Lp(a) using statins (to lower LDL‐C), niacin, proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors,34, 35 or specific Lp(a)‐lowering antisense therapies36 are clearly warranted to confirm the benefits of lipid‐lowering in individuals with high Lp(a), and should pay special attention to the subgroup with concomitant elevations of LDL‐C, who may be at highest cardiovascular risk. It is noteworthy that PCSK9 inhibitors have shown promising results with respect to significantly lowering both Lp(a) and LDL‐C and may serve as the future preferred treatment strategy for patients with familial hypercholesterolemia with combined elevations of Lp(a) and LDL‐C 34, 35, 37.…”

“…It is noteworthy that PCSK9 inhibitors have shown promising results with respect to significantly lowering both Lp(a) and LDL‐C and may serve as the future preferred treatment strategy for patients with familial hypercholesterolemia with combined elevations of Lp(a) and LDL‐C 34, 35, 37. Anacetrapib, the only cholesteryl ester transfer protein inhibitor currently under investigation, has also been suggested to effectively reduce both LDL‐C and Lp(a) levels 38.…”

PCSK9 Inhibitors in Lipid Management of Patients With Diabetes Mellitus and High Cardiovascular Risk: A Review

“…Alirocumab and evolocumab, either alone or in combination with statins and/or other lipid‐lowering therapies, have been shown in their respective phase 3 clinical trial programs (ODYSSEY and PROFICIO [Program to Reduce LDL‐C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different Populations]) to significantly reduce LDL‐C levels by up to 60% from baseline (depending on dosing regimen; Table) in patients with hypercholesterolemia, including those with familial hypercholesterolemia, moderate to very high cardiovascular risk, and statin intolerance 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62. The inclusion/exclusion criteria and other details of each phase 3 ODYSSEY and PROFICIO trial are shown in Table S2.…”

“…The cardiovascular benefits of LDL‐C reductions with a PCSK9 inhibitor were first suggested by the post‐hoc analyses of the phase 3 LONG TERM and OSLER trials 58, 62. Recently, the GLAGOV study found that the addition of evolocumab to statin therapy in patients with angiographic coronary artery disease could lead to regression of atherosclerotic plaques after 76 weeks of treatment in those patients with LDL‐C reductions 64.…”