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The new European lipid guidelines take an aggressive approach



New lipid guidelines from the European Society of Cardiology (ESC) / European Society for Atherosclerosis (EAS) have adopted an aggressive approach with new lower targets for reducing low-density lipoprotein (LDL) than previously observed in most risk categories. [19659002] The new guidelines were published on August 31 at the ESC 2019 Congress and simultaneously published online in the European Heart Journal.

"The key strategy in these guidelines is lower is better and yet it is usually recommended for some time, we say that it still comes down to very low levels of LDL," commented the co-chair of the guidance team Colin Baigent, FRCP, University of Oxford, United Kingdom, theheart.org | Medscape Cardiology.

"We wanted a simpler approach than before, and in patients at highest risk we recommend lowering LDL as much as possible. as much as possible without a lower limit. "

The guidelines give an LDL target of less than 1

.4 mmol / L (<55 mg / dL) for patients with many high risk and even lower target of less than 1.0 mmol / L (<40 mg / dL) for the highest risk patients with multiple recent events.

Baigent added: "For very high patients risk (> 10% risk of death in 10 years) we recommend both a target LDL of 1.4 mmol / L and of at least a 50% reduction. This is much more aggressive than previous guidelines that aim at 1.8 mmol / L or 50% reduction. "

" The difference between "and" and "or" may seem a minor change, but it can make a big difference in some patients. For example, if a very high-risk patient has an untreated LDL of 1.5 mmol / L , which is slightly above target 1.4, then the new recommendation for the need for a 50% reduction in addition to lowering 1.4 would require LDL to be lowered much more – to 0.75 mmol / L. "

" We did this, because you know that risk reduction is directly proportional to the magnitude of LDL reduction. If we want a good risk reduction, we need to increase maximum LDL reduction. "

New LDL targets within CV risk categories

       

  • For patients at very high risk (10-year cardiovascular risk [CV] death> 10%), it is recommended that LDL cholesterol (LDL-C) with at least 50% of baseline and an LDL-C target below 1.4 mmol / L (<55 mg / dL).

  • For very high risk patients who experience a second vascular event within 2 years (not necessarily the same type as the first event) while receiving a maximum tolerated statin therapy, LDL-C target of less than 1, 0 mmol / L (<40 mg / dL) may be

  • For high-risk patients (10-year CV death risk from 5% to 10%), LDL-C reduction of 50% or more, greater than baseline and an LDL-C target of less than 1.8 mmol / L (<70 mg / dL) may be considered.

  • For moderate-risk individuals (10-year CV death risk from 1% to 5%), target for LDL-C below 2.6 mmol / L (<100 mg / dL should be considered] [19659010] For low-risk als individuals (10-year CV death risk <1%), an LDL-C target below 3.0 mmol / L (<116 mg / dL) may be considered.

  •          

"We also recommend that patients should be treated aggressively with high-dose statins and with the ability to add ezetimibe and PCSK9 [p roprotein convertase subtilisin typeillin / subtilisin typeillin inhibitors to achieve these goals. This is another major change from previous guidelines, "said Co-President, François Mach, University Hospital in Geneva, Switzerland.

"We wanted to go beyond what the US did – we thought the evidence supported a more aggressive approach, although more evidence was obtained after the latest US guidelines were issued," Mach commented.

fire and forgetting "not good enough," he added. " We need to continue to review the patient and continue to measure LDL levels to get them as low as possible. Without this approach, patients tend to stop taking their statins. "

" The new target of 1.4 mmol / L for very high-risk patients is easy to justify using data from recent meta-analyzes and trials with high-dose statins and PCSK9 inhibitors, "notes Baigent." Most patients can reach this level with high-dose statin plus ezetimibe. It's a cheap and safe combination. PCSK9 inhibitors will only need to be used in a very small proportion of patients. "

No difference between primary and secondary prevention

Another major change in the new guidelines is the removal of the distinction between primary and secondary prevention.

" What we have done is to make sure that the recommendations are similar to similar level of risk, whether or not the patient had a previous event, "explained Bigen." We did not distinguish between primary and secondary prevention; rather, the risk is calculated in the same way in both settings.

"While patients with secondary prevention is usually with higher risk, the patient with primary prevention may still be at high risk if there are multiple risk factors, and the data show that the benefits of statins themselves do not differ between primary and secondary prophylaxis. risk is important, "he said.

The only exception to this is in the elderly. "While we have strengthened the recommendation for statins in the elderly as a whole, we have made a slightly weaker recommendation for patients with primary prevention over the age of 75," he noted.

Emphasis on Statin Safety

The document has a new section focusing on the safety of aggressive lowering of LDL and statins. "There are no known adverse effects of very low concentrations of LDL," it states.

For statins, "While statins rarely cause serious muscle damage (myopathy or rhabdomyolysis in the most severe cases), there is a great danger to society that statins can usually cause less severe muscle symptoms. Such static intolerance." is often encountered by practitioners and can be difficult to manage. However, placebo-controlled randomized studies show very clearly that true statin intolerance is rare and it is usually possible to initiate some form of statin therapy (eg by changing the statin or reducing the dose) in the vast majority of patients. "

" We want to send a strong message to patients and doctors about this, to try to keep statin patients in the vast majority of cases, "said Mach.

Calcium results, Lp (a), ApoB for stratification The Guidelines

also recommend for the first time the use of new tests to help identify patients at higher risk, including both imaging of coronary artery calcium (CAC) and biomarker tests.

assessment of CAC with CT may be helpful in deciding for treatment in people at moderate risk of atherosclerotic cardiovascular disease, "the document noted." Obtaining such a result may help in discussions about treatment strategies in patients who do not aim for LDL-C. only through lifestyle intervention, and there is the question of whether treatment should be initiated to lower LDL-C. "

Mach commented:" If patients have a very low calcium score, then we can confidently say that they have a very low risk of cardiovascular disease. This is a new recommendation for Europe and aligns the guidelines with the US. "

The guidelines also suggest this assessment of arterial (carotid or femoral) plaque load on ultrasonography may also be informative in these circumstances.

In biomarkers the guidance state: "ApoB may be a better measure of individual exposure to atherosclerotic lipoproteins, and therefore use may be particularly useful for assessing risk in people whose LDL-C measurement underestimates this burden, such as those with you oxidizing triglycerides, diabetes, obesity or very low LDL-C. "

Furthermore recommended single measurement of lipoprotein (a) [Lp(a)] in all subjects. "A single measurement of Lp (a) can help identify people with very high hereditary levels of Lp (a) who may have a significant lifelong risk of cardiovascular disease," the document noted. "It may also be useful in further stratifying the risk of high-risk patients, in patients with a family history of premature cardiovascular disease, and in identifying treatment strategies for people whose prognosis is at the risk category . "

The guidelines also include a recommendation based on the recent REDUCE-IT study of high dose eicosapentaenoic acid (EPA) for patients with elevated triglycerides (TG).

"We recommend the measurement of triglycerides and on the basis of the REDUCE-IT trial it is reasonable to use high-dose EPA (icosapent ethyl) in high-risk patients with TG levels between 1.5 and 5.6 mmol / L (135-499 mg / dL) despite statin treatment, "Baigent said.

Well received by US experts

The new European guidelines have been well received by two US experts contacted by theheart.org | Cardiology of Medscape.

Steve Nissen, a doctor at the Cleveland Clinic in Ohio, says, "These are very thoughtful directions. Europeans are more outspoken than Americans with these guidelines. "

He stated:" I am very pleased with the 'better is better' message and the recommended LDL targets. Recent US guidelines are more focused on recommended treatment thresholds, but the "lower is better" philosophy is very much in line with what I think is right. "[19659018]" Although specific targets for LDL were not allowed in the tests, each trial shows that lower LDL translates into better risk reduction and European guidelines consider the totality of the data and I think it is

Deepak Bhat, MD, Brigham and Women's Hospital, Boston, MA, commented, "There is so much good content in this guide. The Writing Committee should be commended for coming up with so many new actions is a recommendation. "

Bhat stated that he agreed with a huge one most of the recommendations, "in particular, the greater reading of images and biomarkers for low / moderate-risk patients and the greater emphasis on lowering LDL with multiple high-risk therapies."

On imaging recommendations he pointed out that this is an area that is controversial.

"These guidelines really validate these approaches for patient stratification and personalization of therapies, so this is a major conceptual change," Bhat said. "I'm sure there will be objections as there are no randomized supporting data, but in in fact, patients want these tests and in many cases receive them, so the horse is already out of the barn. try and understand how we can incorporate them into our treatment algorithms in ways that are supported. I really think that will be accepted, "he added.

Bhat also agreed that measuring Lp (a) would help identify a new cohort of very high-risk patients who are currently frequently "This will have a huge global impact."

Bhat said the emphasis on statin safety is also welcome. "They send a good message that statin intolerance is too blurred. We can usually get most of it of statin patients if we tend to play with the agent and the dose.

The disclosure forms for all participating experts in the development of these guidelines are available on the ESS website

Eur Heart J Published online 31 August 2019 Full text

Congress of the European Society of Cardiology (ESC) 2019. Submitted on August 31, 2019.

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