News

Rationale for TESLA and results

Low density lipoprotein cholesterol (LDL-C) can be significantly reduced in patients with a serious genetic disorder – homozygous familial hypercholesterolaemia (FH) – when a PCSK9 inhibitor evolocumab is added to statins and other lipid-lowering medications. Professor Frederick Raal explains the results of the TESLA study.

PROFICIO pooled analysis: benefit with evolocumab on LDL and other atherogenic lipoproteins

In the largest assessment of a PCSK9 monoclonal antibody therapy to date, pooled analysis from 4 phase II trials (>1000 patients treated with evolocumab) showed beneficial effects on atherogenic lipoproteins beyond LDL cholesterol. This pooled analysis confirms the benefits of evolocumab treatment among a patient…

Does PCSK9 inhibition on top of statin therapy offer the possibility of further reducing plaque burden?

Stephen J Nicholls MBBS PhD South Australian Health and Medical Research Institute, University of Adelaide, Australia Technical advances in arterial wall imaging have enabled the visualization of the full burden of atherosclerotic plaque. When applied in serial imaging studies of anatomically matched arterial segments, it…

ACC 2015 Evolocumab effective in elderly patients; no safety issues

Treatment with the PCSK9 inhibitor evolocumab was effective in elderly patients (³65 years and ³75 years) with a side effect profile similar to placebo, according to the results of pooled analysis of nearly 2,000 patients from Phase 2, 3 and open-label studies.  These findings specifically…

AHA Scientific Sessions 2014: The Editors view of Day 1

PCSK9 Forum Editor Professor Derick Raal, University of the Witwatersrand, South Africa, discusses the take home messages from the Day 1 Latebreaker Trials IMPROVE-IT After much debate, IMPROVE-IT showed a significant benefit – although only just – with 6.4% reduction (p=0.016) in the primary outcome…

Why is it critical to target children with FH?

Familial hypercholesterolaemia (FH) is the most common genetic disorder in the world. People with FH have high levels of low density lipoprotein cholesterol (LDL-C) resulting in a high risk of premature and sudden death. Now early diagnosis and treatment can save lives, says Dr Albert…

Overlap between HoFH and severe FH and implications for evolocumab

The implications of the overlap between homozygous hypercholesterolaemia and severe familial hypercholesterolaemia (FH) – two genetic disorders characterised by very high levels of low density lipoprotein cholesterol (LDL-C) – should be considered when selecting treatment. Professor Frederick Raal discusses the issue.

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…

Canadian perspective on the 2013 ACC-AHA guidelines on the treatment of blood cholesterol

Professor Robert A. Hegele Western University, London, ON Canada N6A 5B7 email: [email protected] Shortly after publication of the 2013 American College of Cardiology and American Heart Association (ACC/AHA) guidelines on the treatment of blood cholesterol (1), the authors of the 2012 Canadian Cardiovascular Society (CCS)…

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)…

Professor Gerald Watts discusses the 10 countries project in FH

The International Atherosclerosis Society has begun a study in Asia and the Pacific Rim to provide the first comprehensive investigation of the worlds commonest genetic disorder, familial hypercholesterolaemia (FH) in the region. FH results in very high levels of low density lipoprotein cholesterol (LDL-C) and…

R46L variant: an important modifier of the FH phenotype?

Carriage of the PCSK9 R46L loss of function mutation in FH patients appears to counteract the effects of FH-causing LDL receptor mutations, leading an improved phenotype and protection against coronary heart disease. 46L is the most common occurring in exon 1 of the PCSK9 gene,…

Implications from TESLA for FH management

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 2015 ODYSSEY CHOICE: Flexibility in alirocumab dosing

Results from the ODYSSEY CHOICE studies indicate flexibility in dosing with alirocumab, with  4-weekly  regimens shown to be effective and well tolerated, according to Dr Michel Farnier, Point Medical, Dijon, France. Many patients at moderate to high cardiovascular (CV) risk and with poorly controlled hypercholesterolaemia…

Unmet needs in children with FH

Identification and treatment to reduce low density lipoprotein cholesterol (LDL-C) of children with familial hypercholesterolaemia (FH) is vital to reduce the risk of cardiovascular death in early adulthood. FH is the most common genetic disorder in the world. Parents and healthcare professionals need to be…

ODYSSEY long term

Low density lipoprotein cholesterol (LDL-C) was reduced by 60% in patients treated an investigational PCSK9 inhibitor, Alirocumab in addition to statin therapy, for about 52 weeks in the ODYSSEY study. The lead investigator, Professor Jennifer Robinson discusses how this was translated into a reduction in…

Improving the management of the FH patient

Professor Raul Santos from Brazil says that the new therapies which inhibit PCSK9 to significantly reduce low density Lipoprotein Cholesterol (LDL-C) when given in addition to other cholesterol lowering drugs offer a very important advance in reducing cardiovascular risk in people with Familial Hypercholesterolemia (FH).

TAUSSIG – Evolocumab in PCSK9 gain of function mutations

EAS Madrid also offered interesting preliminary findings from the ongoing open-label Phase II TAUSSIG study presented at a latebreaking session.1 Data from five patients recruited in Japan were reported.  In these patients, four had both a PCSK9 gain of function mutation and a LDL-R mutation,…

Role of PCSK9 in acute myocardial infarction?

In a rat model of acute myocardial infarction (AMI), PCSK9 was transiently up-regulated from 12 hours, suggesting that it may play a role in myocardial injury. Investigators measured plasma PCSK9 levels at specified time intervals up to 96 hours following AMI in the rat AMI…