Evolocumab

BANTING

Trial EvolocumaB efficAcy aNd safeTy IN type 2 diabetes mellitus on backGround statin therapy (BANTING) Type 2 diabetes with hypercholesterolaemia/mixed dyslipidaemia: NCT02739984 Aim To evaluate the effect of a 12-week regimen of monthly subcutaneous treatment with evolocumab 420 mg versus placebo, on low-density lipoprotein cholesterol…

EVACS

Trial Evolocumab in Acute Coronary Syndrome (EVACS) ClinicalTrials.gov Identifier: NCT03515304 Aim To evaluate 1) low-density lipoprotein cholesterol (LDL-C) reduction during hospitalization and at 30 days, (2) changes in vascular/plaque and myocardial inflammation at 30 days, (3) serum markers of endothelial function at hospital discharge and…

Evolocumab: effect on lipoprotein particles

Trial Evolocumab: effect on lipoprotein particles and subclasses in heterozygous familial hypercholesterolaemia (HeFH) Aim To evaluate the effect of evolocumab on LDL, VLDL, and HDL particles (LDL-P, VLDL-P, HDL-P), size, and subclass cholesterol content in hypercholesterolaemic and HeFH subjects Study design The study used exploratory…

EVOPACS

Trial EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS) ClinicalTrials.gov Identifier: NCT03287609 Aim To evaluate the safety and effectiveness of evolocumab versus placebo, administered in the acute phase of ACS, for reduction of low-density lipoprotein cholesterol (LDL-C levels) within…

HAUSER-OLE

Evolocumab Study title: HAUSER-OLE Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). ClinicalTrials.gov Identifier: NCT02624869 Aim To describe the safety and…

FDA approves evolocumab to prevent heart attack, stroke, and coronary revascularization

The U.S. Food and Drug Administration (FDA) has approved evolocumab as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. The approval was supported by data from the FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition…

Treatment with evolocumab avoids the use of lipoprotein apheresis in high risk patients

Lipoprotein apheresis is an option in very high risk patients with uncontrolled LDL cholesterol levels despite maximally tolerated lipid lowering therapy. Typically, patients include those with severe familial hypercholesterolaemia (FH, inherited high cholesterol). Yet, while lipoprotein apheresis is effective in reducing LDL cholesterol there are…

Prof Steve Nicholls: Is there a link between the benefit of evolocumab observed in GLAGOV & FOURIER?

Cumulative 4-year OSLER data look good, sustained LDL lowering

In this report from OSLER (Open-Label Study of Long-term Evaluation Against LDL-C), covering the longest exposure to PCSK9 inhibitors to date, there was no decrease in the LDL cholesterol lowering response to evolocumab treatment over time, and no signal for any increase in adverse events….

ESC Poster news: Long-term data with evolocumab in heterozygous FH

30th August 2016, Rome, Italy Evolocumab was effective and well tolerated in patients with heterozygous familial hypercholesterolaemia (FH, inherited high cholesterol) treated for up to 48 weeks (1). Previously, the RUTHEFORD studies in heterozygous FH showed that evolocumab given for 12 weeks was effective in…

FH and PCSK9: Perspective from Japan

Evolocumab recently received approval in Japan for the treatment of patients with familial hypercholesterolemia (FH, inherited high cholesterol) or hypercholesterolaemia who are at high risk of cardiovascular events and do not adequately respond to statins. Here, Professor Harada-Shiba, Osaka, Japan discusses the importance of this…

GAUSS-3 in statin intolerance: top-line results positive with evolocumab

Amgen announced last week that the Phase III study, GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3), evaluating evolocumab in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints of low-density lipoprotein (LDL) cholesterol reduction. Specifically, these related…

Evolocumab first PCSK9 inhibitor licensed in Japan

The Japanese Ministry of Health, Labour and Welfare has approved evolocumab (Repatha) for the treatment of patients with familial hypercholesterolemia (FH, inherited high cholesterol) or hypercholesterolaemia who are at high risk of cardiovascular events and do not adequately respond to statins. Approval was supported by…

Evolocumab: Higher doses, less variability in LDL response

The approval of the PCSK9 monoclonal antibodies offers a novel approach to addressing unmet clinical needs in high cardiovascular risk patients. However, because evolocumab is offered as either 2-weekly or monthly dose regimens further information is needed so clinicians can make the right decision regarding…

Evolocumab and PROFICIO: consistent LDL response across age, sex and risk groups

ESC Congress 2015, London, 30th August 2015 In an analysis of 3,146 patients from four Phase III trials, evolocumab given either 2-weekly or monthly produced similar LDL cholesterol lowering irrespective of age, gender, glycaemic status or cardiovascular risk. The primary endpoint in this analysis was…

PCSK9 inhibitor evolocumab first approved in Europe

Evolocumab is the first PCSK9 inhibitor to be approved in Europe for the treatment of patients with uncontrolled hypercholesterolaemia who require additional intensive low-density lipoprotein (LDL) cholesterol reduction.  This marks the first time that a PCSK9 inhibitor has been approved in the world. Specifically, the…

DESCARTES: No adverse effect on glycaemic control with evolocumab

Evolocumab was effective and well tolerated over 52 weeks with no adverse signal for glycaemic control or new onset type 2 diabetes in patients with pre-existing dysglycaemia or metabolic syndrome. This analysis from DESCARTES included 120 subjects with type 2 diabetes, 293 with impaired fasting…

Good news for PCSK9 inhibitors in diabetes patients

Findings reported for both evolocumab and alirocumab indicate promise for the PCSK9 inhibitors in patients with diabetes, with similar reductions in low-density lipoprotein (LDL) cholesterol as in nondiabetic patients. For evolocumab, there was also no difference in efficacy between 2-weekly and monthly regimens. A pooled…

ISA 2015: Evolocumab in TAUSSIG homozygous FH cohort

News from one of the largest cohort of patients with homozygous familial hypercholesterolaemia (FH, inherited high cholesterol) in the TAUSSIG (Trial Assessing Long-Term Use of PCSK9 Inhibition in Subjects With Genetic LDL Disorders) study strengthens the data for evolocumab.1 In 100 patients with homozygous FH,…

ACC 2015 More safety data with PCSK9 inhibitors: patients with very low LDL-C

Accumulating data with both alirocumab and evolocumab have so far not indicated specific safety issues. In the latest reports at ACC 2015, there were no safety signals in more than 5,000 patients who achieved very low low-density lipoprotein (LDL) cholesterol levels (<25 or <15 mg/dL)…