News

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)…

ACC 2015 Do the evolocumab 2-weekly and monthly regimens provide equivalent LDL-C lowering?

One of the questions clinicians often raise if whether the two dose regimens for evolocumab produce similar low-density lipoprotein (LDL) cholesterol lowering. This study answers this question showing clinical equivalence for changes in lipid parameters, including low-density lipoprotein (LDL) cholesterol, apolipoprotein B and lipoprotein(a). Data…

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…

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…

ACC 2015: CASCADE FH: Unmet needs in education and care of familial hypercholesterolaemia

Baseline data from the CASCADE-FH Registry, presented at ACC 2015, highlight gaps in the care of patients with inherited high cholesterol – familial hypercholesterolaemia (FH). Only about 50% of patients understood the risks of their condition. Treatment was also suboptimal in nearly one-half of patients…

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…

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…

Do we need to re-consider cholesterol treatment in primary prevention?

High cholesterol is a major risk factor for atherosclerosis and coronary heart disease (CHD). However, many individuals with only mild to moderately elevated high cholesterol do not meet guideline criteria for treatment with statins. This poses a key question: Does prolonged exposure to only mild…

How low should LDL-C be lowered? Thoughts of IMPROVE-IT rekindle debate

Undertreatment of FH still an issue in statin era

Despite widespread statin prescribing, individuals with familial hypercholesterolaemia (FH) are dying earlier from cardiovascular disease than those without FH, according to the results of a Norwegian registry study. Under diagnosis and undertreatment of FH have been highlighted as crucial issues warranting urgent action in the…

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…

Oestrogen contributes to variability in PCSK9 levels

Fasting plasma PCSK9 levels vary considerably between healthy individuals, depending on age and sex. In women, a contributing factor could be changes in oestrogen levels, given that studies have shown that increasing oestrogen levels by pharmacological means reduces PCSK9 levels in animals and humans. Investigators…

Peptide-based anti-PCSK9 vaccines around the corner?

Monoclonal antibody therapy to PCSK9 has been first off the block for PCSK9 therapeutics. Extensive clinical trial evidence has shown that these agents are effective, consistently lowering LDL cholesterol by 50-60%, alone or in combination with statin therapy, with no adverse signal to date. However,…

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…

AHA Scientific Sessions – TAUSSIG analysis: Homozygous FH patients on lipid apheresis

Treatment with PCSK9 monoclonal antibody therapy results in further LDL-C lowering in patients with homozygous familial hypercholesterolaemia (FH ) receiving lipid apheresis, provided that they have at least one LDL receptor-defective mutation, according to data from the Trial Assessing Long-Term Use of PCSK9 Inhibition in…

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…

News from AHA Scientific Sessions Latebreakers IMPROVE-IT: support for the lower is better hypothesis

Results from IMPROVE-IT reaffirm the LDL hypothesis that ‘lower is better’.  As incremental benefit on cardiovascular outcomes was seen with the addition of non-statin therapy, IMPROVE-IT bodes well for the PCSK9-targeted therapies. The IMPROVE-IT trial has been the subject of much speculation over the last…

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…

Is there a need for a unified definition for FH?

2014 FH Global Summit: 13-14 October, New York, USA: FH is clearly underdiagnosed and undertreated in the majority of countries.1 Given this status quo, would the development of a unified global definition of FH offer advantages for detection, management and health policy? In the FH…

Not only lower BUT but SOONER is better

2014 FH Global Summit: 13-14 October, New York, USA FH is highly treatable: lowering LDL-C helps in managing the disease process. Clearly, the focus for FH care needs to move from the acute setting to prevention. Identifying FH sooner rather than later is optimal for…