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• W3217609535 abstract "The recently released 2021 European Society of Cardiology (ESC) guidelines on cardiovascular disease (CVD) prevention in clinical practice [[1]Visseren F.L.J. Mach F. Smulders Y.M. et al.ESC Guidelines on cardiovascular disease prevention in clinical practice.Eur. Heart J. 2021; 42 (2021): 3227-3337Crossref PubMed Scopus (235) Google Scholar] were developed to provide healthcare professionals with indications on how to optimize their efforts to reduce the burden of atherosclerosis cardiovascular disease (ASCVD). Compared with the latest version (2016), a number of new recommendations have been introduced, based on the availability of new treatments and the new goals indicated by the most recent ESC guidelines for the management of dyslipidaemias [[2]Mach F. Baigent C. Catapano A.L. et al.ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.Eur. Heart J. 2019; 41 (2020): 111-188Crossref Scopus (2229) Google Scholar], hypertension [[3]Williams B. Mancia G. Spiering W. et al.ESC/ESH Guidelines for the management of arterial hypertension.Eur. Heart J. 2018; 39 (2018): 3021-3104Crossref PubMed Scopus (3800) Google Scholar], and diabetes [[4]Cosentino F. Grant P.J. Aboyans V. et al.ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD.Eur. Heart J. 2019; 41 (2020): 255-323Crossref Scopus (1405) Google Scholar]. The most relevant novelty in these guidelines is that the estimation of CVD risk is based on the application of new algorithms, i.e SCORE2 and SCORE-2-OP. SCORE2 has replaced the previous SCORE algorithm and has been developed to estimate 10-year fatal and non-fatal CVD risk in individuals in Europe without previous CVD or diabetes aged 40–69 years [[5]group Sw collaboration ESCCr SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe.Eur. Heart J. 2021; 42: 2439-2454Crossref PubMed Scopus (47) Google Scholar]. It provides estimates for the combined outcome of fatal and non-fatal CVD events, and it has been recalibrated using the most recent CVD rates available. As most of the 10-year CVD risk prediction models generally have a poor performance in older individuals, which can result in the overestimation of the risk and a consequent excess use of medication, an older person-specific risk score has been created to overcome these limitations. The SCORE2-OP, unlike the original SCORE-OP (which estimated the risk of fatal CVD), takes into account non-fatal CVD events (such as non-fatal stroke) that are clinically relevant in older persons [[6]group SOw collaboration ESCCr SCORE2-OP risk prediction algorithms: estimating incident cardiovascular event risk in older persons in four geographical risk regions.Eur. Heart J. 2021; 42: 2455-2467Crossref PubMed Scopus (25) Google Scholar]. Based on these algorithms, individuals having SCORE2 >7.5% for age under 50, SCORE2 >10% for age 50–69, and SCORE2-OP >15% for age >70 years are considered at very high CVD risk. The application of these two updated algorithms tailored on specific age groups may increase the identification of individuals at high risk of developing CVD, albeit an age-independent approach is definitely needed. We must also underline that in the 2021 ESC guidelines on cardiovascular disease prevention older adults are defined as having 70 years of age or more, whereas in the 2019 ESC/European Atherosclerosis Society (EAS) guidelines for the management of dyslipidaemias older people were defined as those aged >65. This apparently small difference may, however, lead to different recommendations. In fact, 2019 ESC/EAS guidelines recommend treatment with statins for primary prevention, according to the level of risk, in older people aged ≤75 years, whereas initiation of statin treatment for primary prevention in older people aged >75 years may be considered, if at high-risk or above. On the other hand, 2021 ESC prevention guidelines suggest to consider initiation of statin treatment for primary prevention in older people aged >70, if at high-risk or above. Evidence supporting the benefit of statin therapy for primary and secondary prevention of fatal and non-fatal ASCVD events in adults aged 75 years and older are limited. Statins are generally well tolerated drugs, but their use in the elderly, especially in fragile patients or those with multi-pathology taking many other drugs, requires a careful evaluation of the risk-benefit ratio. Of note, secondary analysis of FOURIER and ODYSSEY OUTCOMES trials have shown that mAbs to PCSK9 provide clinical benefits in individuals >69 or ≥65 years old, respectively, comparable to those reported in younger people [[7]Sever P. Gouni-Berthold I. Keech A. et al.LDL-cholesterol lowering with evolocumab, and outcomes according to age and sex in patients in the FOURIER Trial.Eur J Prev Cardiol. 2020; (2047487320902750)Crossref Scopus (20) Google Scholar,[8]Sinnaeve P.R. Schwartz G.G. Wojdyla D.M. et al.Effect of alirocumab on cardiovascular outcomes after acute coronary syndromes according to age: an ODYSSEY OUTCOMES trial analysis.Eur. Heart J. 2020; 41: 2248-2258Crossref PubMed Scopus (23) Google Scholar]. Alongside the main goal of reducing low density lipoprotein cholesterol (LDL-C) levels, 2019 ESC/EAS guidelines also suggest secondary objectives of therapy that include non-high density lipoprotein cholesterol (non-HDL-C) and apoliprotein B (apoB). These two markers play a relevant role in defining the CV risk in specific subgroups of subjects who may present within the range or pharmacologically well controlled LDL-C levels, such as those with metabolic syndrome or diabetes and having an increased CV risk. In fact, these individuals commonly exhibit an atherogenic lipid profile characterized by an increase in apoB levels due to the increase in apoB-containing atherogenic lipoproteins. Thus, the diabetic dyslipidaemia may be better targeted upon measurement of non-HDL-C (i.e., the cholesterol carried by all apoB-containing lipoproteins) and apoB (which provides the number of circulating atherogenic lipoproteins) levels, rather than the solely assessment of LDL-C. For this reason, 2019 ESC/EAS guidelines recommend non-HDL-C and apoB analysis for risk assessment in people with elevated TG, diabetes, obesity, metabolic syndrome, or very low levels of LDL-C. Thus, the indication that apoB provides an information similar to that of calculated LDL-C, as reported in the 2021 ESC prevention guidelines, is only partially acceptable, as it cannot be applied to all individuals. Both non-HDL-C and apoB should be assessed together with other lipid parameters to provide a complete lipid profile and allow the identification of patients that could be misclassified if only characterized based on their LDL-C levels. Of note, the 2021 ESC guidelines on cardiovascular disease prevention highlight the importance of non-HDL-C by replacing total cholesterol with non-HDL-C in the risk chart [[1]Visseren F.L.J. Mach F. Smulders Y.M. et al.ESC Guidelines on cardiovascular disease prevention in clinical practice.Eur. Heart J. 2021; 42 (2021): 3227-3337Crossref PubMed Scopus (235) Google Scholar]. The new guidelines also state that non-HDL-C is a reasonable alternative treatment goal for all patients, particularly for those with hypertriglyceridemia or diabetes. Lipoprotein(a) (Lp(a)) has gained a special relevance in the last years as CV risk factor independent of LDL-C; elevated Lp(a) levels are associated with an increased risk of myocardial infarction, stroke, and aortic valve calcification. Furthermore, individuals with familial hypercholesterolemia have generally higher levels of Lp(a), which may further contribute to their CV risk. Since Lp(a) levels are genetically determined and are not influenced by diet or other environmental factors, 2019 ESC/EAS guidelines suggest to assess Lp(a) levels at least once in life, with the objective to identify people with very high inherited Lp(a) levels (≥180 mg/dL, or ≥430 nmol/L) who have a very high lifetime risk of ASCVD, regardless of their LDL-C levels, whereas there is no mention on this risk factor in 2021 ESC prevention guidelines. We must acknowledge that a 175–250 nmol/L reduction in Lp(a) is required to achieve a clinical benefit comparable to that observed with a 1 mmol/l reduction in LDL-C (i.e., 23%); treatment options to lower specifically and substantially Lp(a) levels are currently under development [[9]Tsimikas S. Karwatowska-Prokopczuk E. Gouni-Berthold I. et al.Lipoprotein(a) reduction in persons with cardiovascular disease.N. Engl. J. Med. 2020; 382: 244-255Crossref PubMed Scopus (227) Google Scholar]. While waiting for the results of outcome trials testing the hypothesis that lowering Lp(a) could reduce CV risk, Lp(a) levels should be assessed together with other lipid parameters, allowing a better risk classification. A point of discussion that can be extended also to 2019 ESC/EAS guidelines for the management of dyslipidaemias is the appropriateness of a stepwise treatment approach in high and very-high risk patients. The new lower LDL-C goals for very-high risk patients in particular, by default from maths alone and observational data, suggest that combination therapy will be needed in approximately 80% of patients [[10]Ray K.K. Molemans B. Schoonen W.M. et al.EU-wide cross-sectional observational study of lipid-modifying therapy use in secondary and primary care: the DA VINCI study.Eur J Prev Cardiol. 2020; Crossref Scopus (74) Google Scholar,[11]Allahyari A. Jernberg T. Hagstrom E. et al.Application of the 2019 ESC/EAS dyslipidaemia guidelines to nationwide data of patients with a recent myocardial infarction: a simulation study.Eur. Heart J. 2020; 41: 3900-3909Crossref PubMed Scopus (23) Google Scholar]. Moreover, statins plus ezetimibe will only achieve LDL-C goals on average in about 40–45% of patients, meaning that at least one third of high/very-high risk patients will require use of a third oral therapy or an injectable therapy. Although the prevention guidelines state that stopping at the first step is inappropriate, the stepwise approach invariably delays control of LDL-C and initiation of add-on therapies in asymptomatic individuals. Delaying control of LDL-C through delays in initiating add-on therapy will impact clinical outcomes in those at highest risk, and attenuates the benefits that might be otherwise achieved through an earlier attainment of better cumulative reductions in LDL-C [[12]Domanski M.J. Tian X. Wu C.O. et al.Time course of LDL cholesterol exposure and cardiovascular disease event risk.J. Am. Coll. Cardiol. 2020; 76: 1507-1516Crossref PubMed Scopus (39) Google Scholar]. Is it still ethical to apply a stepwise approach in patients who are at high or very-high risk of cardiovascular events? This issue is even more crucial now, when after 18 months of the COVID-19 pandemic many patients may have not had their routine check-ups and may have an even increased CV risk. Moreover, LDL-C reduction is a function of what is prescribed (intensity of treatment, which is a function of the therapies prescribed) and the adherence of the patient to the treatment regimen. In this regard, a pragmatic approach is the use of two oral medications as combination therapy as a starting point for those at high/very-high risk and in whom an LDL-C goal <1.4 mmol/L is desirable, with add-on therapy aimed for those failing to achieve goals. This approach is both pragmatic and likely to achieve goal attainment earlier [[13]Ray K.K. Reeskamp L.F. Laufs U. et al.Combination Lipid-Lowering Therapy as First-Line Strategy in Very High-Risk Patients. Eur Heart J, 2021Crossref Scopus (4) Google Scholar]. The authors declared they do not have anything to disclose regarding conflict of interest with respect to this manuscript." @default.
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• W3217609535 title "Prevention guidelines and EAS/ESC guidelines for the treatment of dyslipidaemias: A look to the future" @default.
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