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European society of cardiology scientific update

New ESC guideline: Management of acute coronary syndrome (including video highlights)

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New ESC guideline: Management of cardiovascular disease in diabetes patients

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Video: ESC updates from your collegues. What to implement in practice?

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The penelope study: LDL-C lowering strategy in very high-risk patients with coronary artery disease

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New ESC guidelines for the management of acute coronary syndromes..1

New ESC guidelines for the management of acute coronary syndromes were presented at the ESC congress in Amsterdam. The guidelines cover the entire spectrum of ACS (unstable angina, NSTEMI, and STEMI) and provide guidance on the full ACS patient pathway, including initial assessment, early invasive management, early antithrombotic therapy, revascularization, and secondary prevention. 

The guidelines reinforce the importance of initiating effective secondary prevention already in the acute stage to reduce the risk of new events and to ensure that patients are on evidence-based preventive treatment regardless of subsequent outpatient follow-up. Hence, the new guidelines state that it is recommended to intensify lipid-lowering therapy during the index ACS hospitalization for patients who were on lipid-lowering therapy before admission (new recommendation, class IC). Moreover, combination therapy with a high-dose statin plus ezetimibe may be considered during index hospitalization (new recommendation, class IIbB). This is particularly important in patients with high LDL-C levels at admission and not expected to reach target with single agent treatment alone.  

The guidelines also address the gap between the available evidence-based treatments and real-world usage, and recommend that a polypill should be considered as an option to improve adherence and outcomes in secondary prevention after ACS (new recommendation, class IIaB). Polypills are tablets that contain two or more drugs in one tablet, including lipid-lowering drugs.

Summary: The ESC congress in Amsterdam introduced new guidelines for the management of Acute Coronary Syndromes (ACS), emphasizing early secondary prevention during the acute phase. Recommendations include intensifying lipid-lowering therapy for eligible patients, considering combination therapy with statins and ezetimibe before discharge, and exploring the use of polypills to improve adherence and outcomes in secondary prevention after ACS.

New ESC guideline for the management of cardiovascular disease in diabetes patients.2

The new guideline provides recommendations for reducing CV risk in patients with diabetes, treatment strategies and clinical manifestations of cardio-renal disease such as ASCVD (atherosclerotic cardiovascular disease,), heart failure, atrial fibrillation, and chronic kidney disease (CKD).

Key findings: 

  • Patients with diabetes are at high risk of CVD and CKD. Diabetes and cardio-renal comorbidities together impact the prognosis and treatment strategies in patients. 
  • The 2023 ESC Guidelines recommend systematic screening for diabetes in all patients with CVD. In addition, all patients with diabetes need to be evaluated for risk and presence of CVD and CKD. 

Key recommendations: 

  • ASCVD and diabetes: Sodium–glucose co-transporter-2 (SGLT2) inhibitors and/or glucagon-like peptide-1 receptor agonists (GLP-1 RA) (class IA) are recommended to reduce CV risk, independent of HbA1c or concomitant glucose-lowering medication. 
  • HF and diabetes: SGLT2 inhibitors (class IA) are recommended to reduce the risk of HF hospitalization or CV death. 
  • CKD and diabetes: SGLT2 inhibitors, angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin-II receptor blocker (ARB) and/or finerenone (all class IA) are recommended to reduce both CV and kidney failure risk. Statins are recommended (class I) to reduce CV risk. 
  • Lipids and diabetes: A PCSK9-inhibitor (class IA) is recommended in patients at very high CV risk, with persistently high LDL-C levels above target despite treatment with a maximum tolerated statin dose, in combination with ezetimibe, or in patients with statin intolerance. If a statin-based regimen is not tolerated at any dosage (even after re-challenge), a PCSK9 inhibitor (class IIa-B) added to ezetimibe should be considered. 
  • SCORE2-Diabetes risk score is recommended to predict 10-year risk of fatal and non-fatal CV events (class IB) in patients without ASCVD or severe target organ damage. 
  • A person-centered approach should be adopted for better control and improved health outcomes. 

Video: Which new ESC updates do your colleagues advise you to implement in practice?

Watch this video where your colleagues tell us which new scientific updates of ESC they will translate into clinical practice and would advise their colleagues to consider as well.

The penelope study: Long term effects of a stepwise, structured LDL-C lowering strategy in very high-risk patients with coronary artery disease3,4

With a quick, stepwise intensification of LLT in the PENELOPE study the Dutch target LDL-C ≤1.8mmol/L was met in 95% of patients within 3 months, with a mean LDL-C of 1.41mmol/L. As a legacy effect, after one year the target LDL-C was maintained in 67% of the patients with a mean LDL-C of 1.67mmol/L. Read the full version for more details on this study. 

The PENELOPE study was a multi-center, prospective, non-randomized trial with 999 patients conducted in 23 sites in the Netherlands (January 2019- August 2020). It is a stepwise strategy of lipid-lowering therapy (LLT) to achieve target LDL-C levels in very high-risk patients. Consecutive steps were taken every 4-6 weeks and constituted: 1) high intensity statin (HIST); 2) adding ezetimibe; 3) adding PCSK9i. Within 12 weeks, 95% of patients achieved the Dutch LDL-C target of ≤1.8mmol/L with a mean LDL-C of 1.41mmol/L.3  

During the ESC congress 2023 in Amsterdam, the legacy effect of the PENELOPE study with the one-year follow-up results, was presented. After one year, the lipid panel was available in 738 patients. In 449 patients (67%) target LDL-C level was maintained.  Mean LDL-C level after one year was 1.67 mmol/L. Patient-reported adherence rate to LLT was 94,5%.4  

Fig. 1A LDL-C distribution (mmol/L) from patients (N) at baseline and after one year; 1B Cumulative effect (% patients on LDL-C target) of the three consecutive steps + follow-up; 1C Mean LDL-C (mmol/L) at baseline, end of protocol and follow-up.

References

  1. 2023 ESC Guidelines for the management of acute coronary syndromes. Retrived from: https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-Coronary-Syndromes-ACS-Guidelines 
  2. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Retrieved from: https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/CVD-and-Diabetes-Guidelines
  3. Effects of a guideline-based approach on achieving LDL-c goals. 2022. Retrieved from:  https://pace-cme.org/2022/11/14/effects-of-a-guideline-based-approach-on-achieving-ldl-c-goals/ 
  4. Presented during the ESC congress 2023 in Amsterdam at the moderated ePoster session on Monday 28 August of 2023 

Praluent (alirocumab) abbreviated prescribing information

Name of the medicinal product: Praluent 75 mg, 150 mg or 300 mg solution for injection in pre-filled pen. Qualitative and quantitative composition: Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml solution, 150 mg alirocumab in 1 ml solution or 300 mg in 2 ml solution. Therapeutic indications: Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Established atherosclerotic cardiovascular disease  Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Posology and method of administration: Prior to initiating alirocumab secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded. The usual starting dose for alirocumab is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously. The dose of alirocumab can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.  If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule. No dose adjustment is needed for elderly patients, or patients with mild or moderate hepatic or renal impairment, in patients based on weight. The safety and efficacy of Praluent in children and adolescents less than 18 years of age have not been established. No recommendation on a posology can be made. Alirocumab has not been studied in paediatric patients less than 8 years of age. Method of administration Subcutaneous injection into the thigh, abdomen or upper arm. Each pre-filled pen is for single use only. To administer the 300 mg dose, either one 300 mg injection or two 150 mg injections should be given consecutively at two different injection sites. It is recommended to rotate the injection site with each injection. Alirocumab should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections. Alirocumab must not be co-administered with other injectable medicinal products at the same injection site.  The patient may either self-inject alirocumab, or a caregiver may administer alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique. The solution should be allowed to warm to room temperature prior to use. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions for use: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Allergic reactions General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies. Angioedema has been reported in the postmarketing setting. If signs or symptoms of serious allergic reactions occur, treatment with alirocumab must be discontinued and appropriate symptomatic treatment initiated. Renal impairment In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 ml/min/1.73 m2). Alirocumab should be used with caution in patients with severe renal impairment. Hepatic impairment Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Alirocumab should be used with caution in patients with severe hepatic impairment. Undesirable effects: injection site reactions, upper respiratory tract signs and symptoms, pruritus, urticaria, eczema nummular hypersensitivity. Marketing authorisation holder: Sanofi Winthrop Industry, 82, avenue Raspail, 94250 Gentilly, France. Date of revision of the text: December 2022. Medicinal product subject to restricted medical prescription. Detailed information on this medicine is available on European Medicines Agency website http://www.ema.europa.eu

Netherlands
ATC-code: C10AX14. Aflevering en vergoeding: U.R. Praluent wordt volledig vergoed met additionele voorwaarden. Voor prijzen zie de Z-index taxe. Deze informatie is het laatst herzien in juni 2022. Voor meer informatie zie de geregistreerde productinformatie.Lokale vertegenwoordiger:  Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam Tel 020245400

Belgium
Marketing authorization numbers: EU/1/15/1031/002; EU/1/15/1031/003; EU/1/15/1031/008; EU/1/15/1031/009; EU/1/15/1031/020 and 020. Delivery on medical prescription. 

Sweden
Prescription medication. Reimbursement: Reimbursed for patients with diagnosed heterozygous familial hypercholesterolemia who despite maximal tolerable treatment with statin and ezetimibe have residual LDL cholesterol of  2,6 mmol/l or higher and for patients with diagnosed atherosclerotic cardiovascular disease who despite maximum tolerable treatment with statin and ezetimibe have residual LDL cholesterol of 2,0mmol/l or higher. C10AX14.The SmPC is available on www.fass.se. In Sweden Praluent is provided by Sanofi AB, Box 300 52, 104 25 Stockholm, tel +46 8 634 50 00. For questions on our medicinal products, please contact infoavd@sanofi.com.
Norway
Reseptstatus: C Pakninger og priser: Pakninger og priser: 75 mg/ml: 2 stk. (ferdigfylt penn) kr 4638,90. 6 stk. (ferdigfylt penn) kr 13855,50. 150 mg/ml: 2 stk. (ferdigfylt penn) kr 4638,90. 6 stk. (ferdigfylt penn) kr 13855,50. 300 mg/2 ml: 3 stk. (ferdigfylt penn) kr 13855,50.

  Familiӕr hyperkolesterolemi* Hyperkolesterolemi ved etablert aterosklerotisk sykdom** (sekundӕrprevensjon)
LDL-C > 2,6 mmol/l FH-sekundӕrprevensjon Med en av følgende risikofaktorer:
  • Tidligere hjerteinfarkt
  • Med tilbakevendende CV-hendelser
  • Diabetes mellitus 
LDL-C > 3,6 mmol/l FH-primӕrprevensjon Uten tilleggsrisiko

Krav til tidligere behandling: Refusjon ytes når alirokumab brukes som tillegg til statin og/eller ezetimibe hos pasienter som ikke oppnâr LDL-nivåer under grenseverdiene nevnt ovenfor. Se følgende krav***
Spesialistkrav: Forskrivning skal vӕre instituert av spesialist i indremedisin, kardiologi, endokrinologi, geriatri, nevrologi, eller av lege ved tilsvarende sykehusavdeling    

* Gentest må være utført    
** Sekundærprofylakse etter akutt koronarsykdom (hjerteinfarkt, ustabil angina med sykehusinnleggelse), koronar- eller annen arteriell revaskularisering, angina pectoris,ischemisk hjerneslag eller symptomatisk perifer arteriell sykdom     
*** For brukere som tåler statiner: Høyeste tolererbare dose statin i kombinasjon med ezetimib. For brukere som ikke tåler statiner (statinintoleranse): Minst to forskjellige statiner i laveste dose i kombinasjon med ezetimib. Intoleranse må dokumenteres i journal av forskrivende lege. Ved absolutt kontraindikasjon mot statiner: ezetimib i monoterapi.

Refusjonskoder ICD: -26 etablert aterosklerotisk sykdom (sekundӕrprevensjon) og E78 ren hyperkolesterolemi. ICPC: -26 etablerte atersklerotisk sykdom og T93 hyperkolesterolemi.  
Lokal representant: sanofi-aventis Norge AS, Prof. Kohts vei 5-17, 1325 Lysaker. +47 67 107100
Fullstendig preparatomtale finnes på hjemmesiden til statens legemiddelverk https://legemiddelsok.no/

MAT-BE-2300978 V. 2.0