News
Alirocumab shows benefit in SAMS with myotonic dystrophy
There are currently few options for patients with statin intolerance and myotonic dystrophy. In this case report, a 74-year-old male with hypercholesterolaemia (serum LDL cholesterol 210 mg/dL), hypogonadism, insulin-controlled type 2 diabetes mellitus, and minimally elevated serum creatine kinase levels (184 U/L, ref. range 38-174),…
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PCSK9 inhibitors: effects on glycaemia and HbA1c
Treatment with a PCSK9 inhibitor for a mean of 1.5 years led to a small albeit significant increase in plasma glucose and HbA1c, according to the results of this meta-analysis of more than 68,000 patients treated in phase 2/3 trials. With this short duration of…
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ODYSSEY-KT: Alirocumab shows benefit in trial in S. Korea and Taiwan
This trial showed the benefit of PCSK9 inhibition in high risk patients from these countries, evidence for which had been lacking to date. The study enrolled 199 individuals from South Korea and Taiwan (mean age 61 years, 82% male) with hypercholesterolaemia and coronary heart disease…
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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…
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More poster news: Patient-reported barriers to use of PCSK9 inhibitors
Results from this web-based US survey show that cost was the main reason given by patients for low initial and ongoing use of PCSK9 inhibitors. This survey was completed by 769 patients who signed up for a pharmaceutical company-sponsored patient support program after prescription for…
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More poster news: Adherence to PCSK9 inhibitor therapy
In the ODYSSEY Open-Label Extension Study, adherence to continuation of alirocumab treatment was not an issue. The ODYSSEY Open-Label Extension Study included patients with heterozygous familial hypercholesterolemia (FH, inherited high cholesterol) after completion of 4 Phase 3 placebo-controlled studies (FH I, FH II, LONG TERM,…
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More real-world experience with PCSK9 inhibitors
In this report from Charité Berlin, PCSK9 inhibitor therapy was effective in 499 patients with high and very high cardiovascular risk and substantial LDL cholesterol burden. Patients were either unable to attain guideline defined LDL cholesterol goal with maximally tolerated lipid lowering therapy or were…
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GLAGOV diabetes analysis: atheroma regression with evolocumab similar to nondiabetics
Treatment with evolocumab resulted in comparable regression of coronary atherosclerosis in statin-treated patients with and without diabetes, reinforcing the need for intensive lipid lowering in diabetes patients. GLAGOV (GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound) compared the effects…
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SPIRE FH Analysis: PCSK9 inhibition reduces cardiovascular events in FH patients
Statin-treated patients with familial hypercholesterolaemia (FH, inherited high cholesterol) derive a similar reduction in cardiovascular events with the PCSK9 inhibitor bococizumab as patients without FH, according to this analysis of data from six SPIRE studies. Outcomes trials in FH patients in the modern era of…
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AHA Scientific Sessions 2017: More insights from FOURIER into very high-risk patients: PAD and high-risk MI
New analyses from FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) reinforce the very high risk of cardiovascular events in patients with peripheral arterial disease (PAD), recurrent myocardial infarction (MI) and multivessel disease. In patients with PAD, evolocumab on top…
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Ten Countries Study: Familial hypercholesterolaemia care lags behind in the Asia-Pacific region
Familial hypercholesterolaemia (FH, inherited high cholesterol) is the most common and serious form of inherited hyperlipidaemia (1). Yet, despite its clinical importance, there is still a major shortfall in FH care. Much of the information relates to Europe and North America; the Ten Countries aimed…
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More real-world data with PCSK9 inhibitors
In the light of cardiovascular outcomes data from FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) (1), the Joint Task Force of the European Society of Cardiology and European Atherosclerosis Society recently updated practical guidance for the use of PCSK9…
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Cholesterol variability is a predictor of adverse outcome in the general population
Data from a large Korean cohort highlights visit-to-visit variability in cholesterol levels as an important cardiovascular risk factor in the general population. This adds to previous evidence that variability in cholesterol levels is an independent predictor of major adverse cardiovascular events in patients with coronary…
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New meta-analysis reaffirms benefit of more intensive LDL lowering on cardiovascular outcome
Irrespective of the type of therapy, more intensive lowering of LDL cholesterol was associated with 19% reduction in major vascular endpoints compared with less intensive treatment. This meta-analysis identified 19 trials (15 with statins, 3 with PCSK9 inhibitors, and one with ezetimibe) in 152,507 patients…
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Why the 2017 ESC/EAS practical guidance on PCSK9 inhibition is needed
In the largest US analysis to date, higher LDL cholesterol levels were not associated with higher payer approval rates for PCSK9 inhibitor therapy. These data reaffirm the need for practical guidance, such as that published by a Joint Task Force from the European Society of…
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Alirocumab effective against the spectrum of mutations causative for familial hypercholesterolaemia
Alirocumab treatment was effective in patients heterozygous for mutations in LDLR, APOB, and PCSK9 genes. This analysis investigated the efficacy of alirocumab in 1191 patients with familial hypercholesterolaemia (FH, inherited high cholesterol) included in 6 trials; 758 were treated with alirocumab. One or more specific…
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New network meta-analysis of PCSK9 inhibitor efficacy
This analysis reaffirms the efficacy of PCSK9 monoclonal antibody therapy added to medium- to high-intensity statin therapy in lowering LDL cholesterol. The authors reviewed 69 trials of lipid-lowering therapies that enrolled patients requiring further LDL cholesterol reduction while on maximally tolerated medium- or high-intensity statin…
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Familial hypercholesterolaemia-causing mutations prevalent in ACS
According to this Spanish study, one in 10 patients aged < 65 years with an acute coronary syndrome and elevated LDL cholesterol levels has a mutation causative for familial hypercholesterolaemia (FH, inherited high cholesterol). The study assessed the prevalence of mutations in 7 genes (LDLR,…
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Another CETP hits the dust: anacetrapib terminated
Merck (known as MSD outside the U.S. and Canada) has decided not to submit applications for regulatory approval for the cholesteryl ester transfer protein (CETP) anacetrapib, after a thorough review of the clinical profile of this drug. This follows on from the publication of the…
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More from FOURIER: Evolocumab effective in diabetics, no impact on glucose control
The latest report from the FOURIER (Further cardiovascular Outcomes Research with PCSK9 Inhibition in subjects with Elevated Risk) trial (1) shows that treatment with the PCSK9 inhibitor evolocumab was similarly effective in patients with and without diabetes. Importantly, evolocumab did not increase the risk of…
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