News

RUTHERFORD-2 slide deck now available

What are the gaps in knowledge about the PCSK9 inhibitors

New slide set: PCSK9 for LDL cholesterol reduction: what have we learned?

Dr Evan Stein, University of Cincinnati, Cincinnati, Ohio overviews what we have learned so far from trials with the PCSK9 monoclonal antibody therapies. Rationale for PCSK9 inhibition First in man studies Phase II studies

Statins and muscle symptoms: New EAS Consensus Panel statement

The European Atherosclerosis Society (EAS) Consensus Panel has published new guidance on the diagnosis, assessment and treatment of statin-associated muscle symptoms (SAMS). Unique to this statement is an overview of current understanding of the pathophysiology of statin myopathy. Without doubt, statins are the therapeutic cornerstone…

News from AHA Scientific Sessions 2014 – Heterozygous FH: Do we need a genetic diagnosis?

There was debate regarding the merits of genotype versus phenotype for diagnosis of heterozygous FH among the avenue of lipid posters.  In this report based on data from the RUTHERFORD-1 and -2 studies, the accuracy of clinical and genetic diagnosis was compared in patients with…

News from AHA 2014 ODYSSEY ALTERNATIVE in statin-intolerant patients

Alirocumab shows efficacy in statin intolerant patient with fewer muscle-related adverse events than atorvastatin. There was virtually no myalgia among patients who continued on open-label alirocumab, reinforcing that the fear of allocation to statin has had an enormous effect in the blinded study phase. Statin…

Mind the Gap: How can we address the challenges in FH?

2014 FH Global Summit: 13-14 October, New York, USA Screening for FH needs new impetus. Family history and an elevated LDL-C are the two key screening criteria for suspected FH. The obvious role for screening for suspected FH lies with primary care. Insights from the…

LAPLACE-2 published in JAMA

The LAPLACE-2 (LDL-C Assessment with PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy – 2) previously reported at ACC 2014, is now published in JAMA. Robinson JG, Nedergaard BS, Rogers WJ et al; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate or high-intensity…

PROFICIO: Evolocumab reduces Lp(a) in statin-treated patients

In a pooled analysis of 4 phase 2 trials including more than 1300 patients, treatment with the PCSK9 monoclonal antibody evolocumab led to dose-related reductions in Lp(a) which were sustained during longer-term therapy. The pooled population (n=1,359) had a mean age of 56.4 (11.7) years,…

Update on the status of PCSK9 monoclonal antibody therapies

The discovery of proprotein convertase subtilisin/kexin type 9 (PCSK9) in cholesterol metabolism and the subsequent development of monoclonal antibody therapies is a key example of translational medicine. At least 5 companies now have an agent in clinical trials, with 3 in Phase II development. The…

Unmet clinical needs in cholesterol lowering

Recent decades has seen marked improvement in reducing rates of heart disease and stroke (cardiovascular disease), particularly in developed nations.1 High levels of low-density lipoprotein cholesterol (LDL-C), or ‘bad cholesterol’ are considered a major risk factor for cardiovascular disease. International guidelines state that reduction of…

Understanding the role of PCSK9 in dyslipidaemia

EAS Consensus Panel focuses on homozygous FH

As a follow-up to the 2013 EAS Position Statement on FH,1 this new position paper specifically focuses on homozygous FH. This rare disease is characterised by markedly elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease.  Due to the severity…

ACC 2015: What do the OSLER and ODYSSEY data really show? Expert analysis from Professor Derick Raal

March 15, 2015 At an eagerly anticipated hotline at ACC 2015, a pre-specified, exploratory analysis of the OSLER studies, showed that the PCSK9 monoclonal antibody evolocumab reduced low-density lipoprotein (LDL) cholesterol by 61%, and that this was associated with a 53% reduction in cardiovascular events…

PCSK9 inhibition: lipid-modifying benefits beyond LDL-C lowering

Recent evidence indicates that PCSK9 also modulates the metabolism of triglyceride-rich apolipoprotein B (apoB) lipoproteins, another important coronary heart disease risk factor. This suggests that PCSK9-targeted therapies may also have a role in the management of postprandial hypertriglyceridaemia, highly relevant in obese individuals. To investigate…

ODYSSEY FH and patient unmet needs

Less than 1% of people with familial hypercholesterolaemia (FH), the commonest genetic disorder in the world are diagnosed. As FH patients have significantly elevated levels of low-density lipoprotein cholesterol (LDL-C) their consequent risk of cardiovascular death is greatly increased. Therefore, the results of the ODYSSEY…

ODYSSEY FHI FHII

Fewer than 80% of familial hypercholesterolaemia (FH) patients achieved an LDL-C level of

ODYSSEY trials at ESC Congress Hotline

ESC Congress 2014: Lipids Hotline: ODYSSEY TRIALS Prof Alberto Zambon, University of Padua, Italy discusses the four ODYSSEY trials with the PCSK9 inhibitor alirocumab presented at ESC Congress Hotline Sunday. Addition of a new investigational agent – Alirocumab – to high doses of statins result…

The role of PCSK9 inhibitors in FH

Monoclonal antibodies targeting PCSK9 have been shown to reduce low density lipoprotein cholesterol (LDL-C) by 30-40% in patients with familial hypercholesterolaemia (FH) who still have LDL receptors. Studies also show that the investigational drug, evolocumab was well tolerated, Dr Dirk Blom said.

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…