Already a member? Become a member Register
PCSK9 Forum

rss LinkedIn News
rss LinkedIn Latest News Updates

News

VESALIUS-CV: New outcomes study with evolocumab

VESALIUS-CV: New outcomes study with evolocumab

Amgen has announced a new cardiovascular outcomes study in patients at high risk of cardiovascular events who are already receiving lipid lowering treatment but have not had a previous myocardial infarction (MI) or stroke. VESALIUS-CV is a multinational, double-blind, randomised, placebo-controlled, parallel-group clinical outcomes study…

read more »
New US FDA approval for alirocumab

New US FDA approval for alirocumab

Based on data from ODYSSEY OUTCOMES (1), the Food and Drugs Administration has now approved alirocumab to prevent heart attack, stroke and unstable angina requiring hospitalization. ODYSSEY OUTCOMES, the longest cardiovascular outcomes trial of any PCSK9 inhibitor to date, assessed the effect of alirocumab on…

read more »
Familial hypercholesterolaemia in China – registry urgently needed

Familial hypercholesterolaemia in China – registry urgently needed

The size of the population in China implies a major burden of familial hypercholesterolaemia (FH, inherited high cholesterol). Yet, like the majority of countries world-wide, FH is underdiagnosed and undertreated. China may pose specific issues that contribute to this. Cholesterol levels have been lower in…

read more »
OSLER 5-year data in Japanese: evolocumab continues to impress

OSLER 5-year data in Japanese: evolocumab continues to impress

Treatment with evolocumab, in addition to standard of care including statin therapy, was well tolerated and led to sustained reduction in LDL cholesterol in Japanese subjects enrolled in the long-term OSLER studies (Open-Label Study of Long-Term Evaluation Against LDL-C). The OSLER studies were designed to…

read more »
Who is receiving PCSK9 inhibitors in the real world?

Who is receiving PCSK9 inhibitors in the real world?

PCSK9 inhibitors have been endorsed for use in patients at high and very risk of cardiovascular events (1,2). In the real-world, however, which type of patients are more commonly prescribed a PCSK9 inhibitor? Findings based on data from three Danish registries indicate that the majority…

read more »
Cost remains the issue for use of PCSK9 inhibitors

Cost remains the issue for use of PCSK9 inhibitors

PCSK9 inhibitors are highly efficacious LDL cholesterol lowering treatments that have been endorsed by guidelines and experts for use in very high-risk patients (1-3). The key groups identified by these groups have been patients with clinical atherosclerotic cardiovascular disease (ASCVD), familial hypercholesterolaemia (FH, inherited high…

read more »
PlayBANTING study in type 2 diabetes: evolocumab improves lipid goals and postprandial lipids

BANTING study in type 2 diabetes: evolocumab improves lipid goals and postprandial lipids

Results from the BANTING study add to the evidence-base that PCSK9 inhibition is efficacious in improving lipid goal attainment in individuals with type 2 diabetes mellitus (T2DM) with hypercholesterolaemia or mixed dyslipidaemia. There were also favourable changes in postprandial lipids. Dyslipidaemia is one of the…

read more »
Alirocumab: EU Regulatory update

Alirocumab: EU Regulatory update

The European Union (EU) has now approved alirocumab, a PCSK9 (proprotein convertase subtilisin/kexin type 9) monoclonal antibody, to reduce the risk of cardiovascular events in patients with established cardiovascular disease.1 The approval is based on data from the ODYSSEY OUTCOMES trial, which not only showed…

read more »
Diabetes does not affect the efficacy of inclisiran

Diabetes does not affect the efficacy of inclisiran

A new analysis from the ORION-1 trial shows that the efficacy and safety of inclisiran, a small interfering RNA (siRNA) therapeutic, is not influenced by diabetes status. Inclisiran differs from monoclonal antibody therapy by acting intracellularly in the liver to inhibit synthesis of PCSK9 protein…

read more »
Statins versus PCSK9 inhibitors: new metabolomic analysis

Statins versus PCSK9 inhibitors: new metabolomic analysis

What explains the cardiovascular outcomes benefit with a statin or a PCSK9 inhibitor? Do effects on LDL cholesterol, as well as lipids beyond LDL cholesterol differ? A metabolite profiling study provides new insights. Treatment with statin monotherapy or as add-on to a PCSK9 inhibitor has…

read more »
New meta-analysis of PCSK9 inhibitors: a mortality benefit or not?

New meta-analysis of PCSK9 inhibitors: a mortality benefit or not?

A new meta-analysis lends further support that PCSK9 inhibition reduces nonfatal major adverse cardiovascular events (MACE). However, the jury is still out regarding effects on mortality. Randomized controlled trials of at least 6 months duration were identified from searching CENTRAL, Embase, MedLine and the grey…

read more »
Stratifying risk in familial hypercholesterolaemia: does coronary artery calcium have a role?

Stratifying risk in familial hypercholesterolaemia: does coronary artery calcium have a role?

PCSK9 Forum Editors Professor Gerald Watts (University of Western Australia, Perth, Australia) and Professor Derick Raal (University of the Witwatersrand, Johannesburg, South Africa) give their view. As a result of life-long exposure to high LDL cholesterol levels, individuals with familial hypercholesterolaemia (FH, inherited high cholesterol)…

read more »
Coronary artery calcium in familial hypercholesterolaemia

Coronary artery calcium in familial hypercholesterolaemia

Coronary artery calcium (CAC) score may have a role in stratifying short-term risk in patients with familial hypercholesterolaemia (FH, inherited high cholesterol), according to a new study. The authors suggest that this noninvasive approach may have value in targeting treatment with a PCSK9 inhibitor to…

read more »
Future dual PCSK9/GLP-1 therapy for diabetes patients?

Future dual PCSK9/GLP-1 therapy for diabetes patients?

Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Management is multifactorial, targeting major modifiable risk factors including glycaemia, dyslipidaemia, obesity and hypertension. Despite this, less than 10% of patients achieve combined target goals. To address this…

read more »
ODYSSEY OUTCOMES in press finally!

ODYSSEY OUTCOMES in press finally!

Final results of ODYSSEY OUTCOMES, presented at this year’s American College of Cardiology Annual Scientific Sessions, were published today. Together with the results of FOURIER (1) there is now definitive evidence for the outcomes benefits of PCSK9 inhibition in very high-risk patients, in this case,…

read more »
NEW Complementary slide resources…

NEW Complementary slide resources…

PCSK9 Forum is globally-recognised as an independent, non-profit resource of expert knowledge of PCSK9 science and its translation to therapeutic innovation. The mission of PCSK9 Forum is to increase awareness and understanding of this exciting new development among healthcare professionals. For more information about the PCSK9…

read more »
Alirocumab safe in patients with diabetes mellitus

Alirocumab safe in patients with diabetes mellitus

Safety analysis from 14 ODYSSEY trials involving more than 5000 patients shows a similar safety profile for alirocumab irrespective of diabetes status. This pooled analysis from the ODYSSEY development programme included 14 trials (8-104-weeks duration) with 5234 patients, 1554 (29.7%) with diabetes.  Adverse event data…

read more »
PROFICIO analysis shows consistent LDL lowering with evolocumab

PROFICIO analysis shows consistent LDL lowering with evolocumab

Treatment with the PCSK9 inhibitor evolocumab produced a consistent LDL cholesterol lowering response, irrespective of age, gender, ethnicity, glucose tolerance status or global cardiovascular risk, according to the latest report from the PROFICIO clinical trial programme. PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following…

read more »
International Atherosclerosis Society and FH Foundation join forces to improve FH management

International Atherosclerosis Society and FH Foundation join forces to improve FH management

The International Atherosclerosis Society (IAS) and the FH Foundation, a patient-centered nonprofit organization dedicated to research, advocacy, and education of familial hypercholesterolemia (FH, inherited high cholesterol), have announced a partnership to improve awareness of FH. Despite the fact that FH is the most common genetic…

read more »
Two more analyses show efficacy of alirocumab in diabetes

Two more analyses show efficacy of alirocumab in diabetes

Two recent analyses add to the body of evidence supporting the efficacy and tolerability of the PCSK9 inhibitor alirocumab in patients with type 2 diabetes mellitus (T2DM), including those with mixed dyslipidaemia. The first report (1) was a pooled analysis of 5 placebo-controlled Phase 3…

read more »