Guidelines for the Management of Dyslipidaemias
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1 Guidelines for the Management of Dyslipidaemias Etienne PUYMIRAT Département de Cardiologie Hôpital Européen Georges Pompidou Université Paris Descartes, Paris, France Fees for lectures and/or consulting: Amgen, Astra-Zeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Lilly, MSD, The Medicine Company, Sanofi, Saint Jude Medical, Servier
2 Guidelines for the management of dyslipidemias 2016 ESC/EAS Guidelines for the management of dyslipidaemias. EHJ dyslipidemies-strategies-de-prise-en-charge
3 Pathophysiology: LDL-Cholesterol CAUSES Endothelial Dysfunction and Atherogenesis
4 Management of dyslipidemias
5 ESC/EAS Guidelines 2016 ESC/EAS Guidelines for the management of dyslipidaemias. EHJ 2016
6 Recommandations HAS dyslipidemies-strategies-de-prise-en-charge
7 2016 ESC/EAS Guidelines for the management of dyslipidaemias. EHJ 2016
8
9 Forte doses de statines Introduction des statines entre J1 et J4 Objectif LDL-C < 1.8mM (< 0.70 mg/dl) Réévaluation du bilan lipidique entre 4 à 6 semaines 2016 ESC/EAS Guidelines for the management of dyslipidaemias. EHJ 2016
10 Recommandations HAS dyslipidemies-strategies-de-prise-en-charge
11 Recommandations HAS 2017 AMM du 9 août 2016: Prévention des événements cardiovasculaires : LIPTRUZET est indiqué pour réduire le risque d événements cardiovasculaires chez les patients présentant une maladie coronaire avec un antécédent de syndrome coronarien aigu (SCA), précédemment traités ou non par statine. -dyslipidemies-strategies-de-prise-en-charge
12 Recommandations HAS 2017 AMM du 10 mai 2016 : «en prévention des événements cardiovasculaires : EZETROL est indiqué pour réduire le risque d événements cardiovasculaires chez les patients présentant une maladie coronaire avec un antécédent de SCA, en complément d un traitement en cours par statine ou avec l initiation concomitante d une statine» Cette nouvelle indication repose notamment sur les résultats de l étude IMPROVE-I -dyslipidemies-strategies-de-prise-en-charge
13 Study Design Patients stabilized post ACS 10 days: LDL-C *mg/dL (or **mg/dL if prior lipid-lowering Rx) *3.2mM **2.6mM N=18,144 Standard Medical & Interventional Therapy Simvastatin 40 mg Uptitrated to Simva 80 mg if LDL-C > 79 (adapted per FDA label 2011) Ezetimibe / Simvastatin 10 / 40 mg Follow-up Visit Day 30, every 4 months 90% power to detect ~9% difference Duration: Minimum 2 ½-year follow-up (at least 5250 events) Primary Endpoint: CV death, MI, hospital admission for UA, coronary revascularization ( 30 days after randomization), or stroke Cannon CP AHJ 2008;156:826-32; Califf RM NEJM 2009;361:712-7; Blazing MA AHJ 2014;168:205-12
14 LDL-C and Lipid Changes 1 Yr Mean LDL-C TC TG HDL hscrp Simva EZ/Simva Δ in mg/dl Baisse de 26% Median Time avg 69.5 vs mg/dl Baisse de 43%
15 Primary Endpoint ITT Cardiovascular death, MI, documented unstable angina requiring rehospitalization, coronary revascularization ( 30 days), or stroke HR CI (0.887, 0.988) p=0.016 Simva 34.7% 2742 events NNT= 50 EZ/Simva 32.7% 2572 events 7-year event rates
16 Safety ITT No statistically significant differences in cancer or muscle- or gallbladder-related events Simva n=9077 % EZ/Simva n=9067 % p ALT and/or AST 3x ULN Cholecystectomy Gallbladder-related AEs Rhabdomyolysis* Myopathy* Rhabdo, myopathy, myalgia with CK elevation* Cancer* (7-yr KM %) * Adjudicated by Clinical Events Committee % = n/n for the trial duration
17 # Events Total Primary Endpoint Events 4983 Total Events RR 0.91 P= Additional Events RR 0.88 ( ) st Event HR P= Simvastatin Alone Ezetimibe Simvastatin
18 Recommandations HAS 2017 Bilan lipidique de contrôle: 8-12 S -dyslipidemies-strategies-de-prise-en-charge
19 French data 2010 STEMI NSTEMI AMI LDL, mg/dl 1.23 ± ± ± 0.43 Statines : - Before - < 48 h - At discharge 22% 91% 94% 35% 85% 89% 28% 88.5% 92% Atorvastatine 80mg 63% 43% 55.5% 30% 59.5% 38% Rosuvastatine 20mg 26% 9.5% 24% 7% 25% 8.5% Personnal data
20 French data : medications at discharge NSTEMI STEMI , ASA Clopidogrel Prasugrel Ticagrelor Any P2Y12- i VKA DOA Statin Ezetimibe Betablocker ACE-i or ARB Personnal data
21 ESC/EAS Guidelines Global high-risk markers on coronary CTA : Left main disease Prox LAD disease 3 Vessel disease Focal high-risk markers on coronary CTA : Sténosis severity >50% Lesion composition : mixed or non-calcified 2017 Update of ESC/EAS Task Force on practical clinical guidance for PCSK9 inhibitors. EHJ 2017
22 Clinical practice 3 messages for GPs : 1) If the LDL-C target is not reached with current medications : increase doses of statin (highest tolerable statin dose), consider ezetimibe 2) LDL-C : lower is still better 3) To screen familial hypercholesterolemia 3 messages for patients : 1) The debate about statins does not concern patients in secondary prevention 2) Impact on mortality from stopping statins in large database 3) Press release of the French cardiology society
23 COMMUNIQUE DE PRESSE SFC SUR STATINES 04 DEC 2017 Il n y a pas un seul médicament en médecine préventive qui ait un niveau de preuves d efficacité aussi élevé que les statines. Les statines allongent l espérance de vie des patients à risque, diminuent les événements cardioneuro-vasculaires (infarctus et AVC notamment) et ont un risque d effets indésirables limité largement compensé par l ampleur des bénéfices. Nier le bénéfice des statines et leur impact sur l espérance de vie, c'est à la fois malhonnête (en niant les faits scientifiques) et dangereux (pour les patients qui de bonne foi arrêteront leur traitement). Nier les progrès thérapeutiques, porter la suspicion sur les médecins, c est aussi ignorer l amélioration incontestable du pronostic cardiovasculaire dans notre pays, la France, avec, pour exemple, une chute spectaculaire de 68 % en 15 ans de la mortalité hospitalière après infarctus du myocarde et une baisse de 56% en 28 ans de la mortalité cardiovasculaire.
24 Conclusion Current ESC/EAS and HAS guidelines recommend for management of dyslipidaemias in patients at very high risk a LDL-C goal < 70mg/dL (or 1,8 mmol/l) or a reduction of at least 50% In patients admitted for ACS, it is recommended : To initiate or continue high dose statins early after admission Ezetimibe should be considered in combination with statins if the LDL-C target is not reached with highest tolerable statin dose PCSK-9 inhibitors may be considered if the LDL-C target is not reached with highest tolerable statin dose and/or ezetimibe Lipids should be re-evaluated 4-6 (or 8-12) weeks after ACS. Therapy dose should be adapted accordingly
25
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