<p data-font="small">* MACE Major adverse cardiovascular events = CHD death, nonfatal myocardial infarction, fatal and nonfatal ischaemic stroke, or unstable angina requiring hospitalisation.<br>
  ** A post hoc assessment using data from the ODYSSEY OUTCOMES trial. With PRALUENT, 94.6% of patients achieved LDL-C, 1.4 mmol/L at~, post-baseline measurement vs. 17.3% with placebo.<sup>3</sup><br>
  † Baseline LDL-C 2,3 mmol/L.<br>
  ‡ PRALUENT is the only PCSK9i with once-monthly single injection in a pre-filled pen.<sup>2</sup></p>
<p data-font="small"><strong>ACS&nbsp;</strong>= acute coronary syndrome;&nbsp;<strong>Cl&nbsp;</strong>= confidence interval;&nbsp;<strong>HR&nbsp;</strong>= hazard ratio;&nbsp;<strong>LDL-C</strong>&nbsp;= low-density lipoprotein cholesterol;&nbsp;<strong>MACE&nbsp;</strong>= major adverse cardiovascular event;&nbsp;<strong>PCSK9i&nbsp;</strong>= proprotein convertase subtilisin/kexin type 9 inhibitor;&nbsp;<strong>RRR&nbsp;</strong>= relative risk reduction;&nbsp;<strong>ARR&nbsp;</strong>= absolute risk reduction.</p>

<h2>The long-term efficacy and safety of PRALUENT has been evaluated in an extensive clinical trial programme:</h2>

<h3>The ODYSSEY OUTCOMES trial was a CVOT with ~19,000 very high-CV-risk ACS patients, over 5 years<sup>1,2,5,6**</sup></h3>
<p><strong>Background:</strong>&nbsp;ODYSSEY OUTCOMES aimed to determine whether PRALUENT would improve cardiovascular outcomes after an acute coronary syndrome in patients receiving high-intensity statin therapy.<sup>1</sup></p>

<p>Multicentre, double-blind, placebo-controlled, phase 3 trial<sup>**</sup>&nbsp;N=18,924<sup>1</sup></p>


<p>PRALUENT SC Q2W + max tolerated statins (n=9,462)<sup>1</sup></p>

<p>PLACEBO SC Q2W + max tolerated statins (n=9,462)<sup>1</sup></p>


<p>Primary endpoint:<br />
MACE<sup>1</sup></p>


<p data-font="small" style="text-align: center;">If needed, dose adjustment occurred at month 2 visit<sup>1</sup></p>

<h3>In ODYSSEY OUTCOMES:<sup>1</sup></h3>
<ul>
 <li>Patients with very-high-risk recurrent CV were enrolled, and 100% of patients had an MI or unstable angina</li>
 <li>Patients received PRALUENT alongside the optimal standard of care - 89% were on high-intensity statins</li>
 <li>2.8 years median follow-up, with over 8,000 patients (44%) eligible to be followed for 3–5 years</li>
</ul>

<h3>ODYSSEY OUTCOMES is the longest randomised, placebo-controlled comparison of PCKS9 inhibition to date.<sup>1</sup></h3>
<p>All primary and secondary end points were adjudicated by physicians who were unaware of the trial-group assignments.<sup>1</sup></p>
<p>To adjust for multiplicity, the results of the main secondary end points were tested in hierarchical fashion if the risk of the composite primary end point was found to be significantly lower in the PRALUENT group than in the placebo group.<sup>1</sup></p>
<h2>PRALUENT demonstrated powerful LDL-C reduction vs placebo<sup>1,2§§</sup></h2>

<h3>The LDL-C reduction achieved by PRALUENT was proven to be:</h3>

<h2>Intensive</h2>
<h3>50-60% LDL-C reduction relative to placebo<sup>1*</sup></h3>
<p><sup>* 62.7% LDL-C reduction compared to placebo at 4 months in ODYSSEY OUTCOMES trial.</sup></p>

<h2>Fast</h2>
<h3>4 weeks to reach maximum effect<sup>2‖‖</sup></h3>

<h2>Sustained</h2>
<h3>4 years of LDL-C reduction<sup>1¶¶</sup></h3>

<h3 style="text-align: center;">LDL-C reduction within ODYSSEY outcomes: on-treatment analysis<sup>1</sup></h3>

<p data-font="small" style="text-align: center;">Adapted from Schwartz et al. 2018.<sup>1</sup></p>
<p>Making PRALUENT an option for your ACS patients who are at immediate risk of another CV event and need LDL-C reduction that is both fast and sustained.<sup>8,9</sup></p>

<h2>Reaching LDL-C goal</h2>
<p>In patients at very-high-risk and with an LDL-C goal of &lt;55 mg/dL and a reduction of ≥50% from baseline:<sup>5</sup></p>

<h2>All-cause mortality</h2>
<h3>The ODYSSEY OUTCOMES trial also assessed all-cause mortality reduction in patients treated with PRALUENT vs placebo:<sup>1,2,10§¶¶</sup></h3>

<h2>PRALUENT has established long-term safety profile and experience<sup>1,2,7,11</sup></h2>

<p>The safety profile in ODYSSEY OUTCOMES was comparable to placebo and consistent with the overall safety profile described in the phase 3 controlled trials<sup>1,2</sup></p>


<p>Up to 5 years long-term safety &ndash; the longest randomised, placebo-controlled comparison of PCSK9 inhibition to date<sup>7‖‖‖</sup></p>


<p>In 2023, approximately 570,000 patients globally have been treated with PRALUENT<sup>11&sect;&sect;&sect;</sup></p>


<p>*P&lt;0.001.<sup>1</sup></p>
<p>†New-onset diabetes was defined according to the presence of 1 or more of the following, with confirmation of the diagnosis by blinded external review by experts in the field of diabetes: an adverse event report, a new prescription for diabetes medication, a glycated haemoglobin level of at least 6.5% on 2 occasions (and a baseline level of &lt;6.5%), or a fasting serum glucose level of at least 126 mg/dL (7.0 mmol/L) on 2 occasions (and a baseline level of &lt;126 mg/dL).<sup>1</sup></p>
<p>The safety profile in ODYSSEY OUTCOMES was consistent with the overall safety profile described in the phase 3 controlled trials. The only adverse reaction in ODYSSEY OUTCOMES occurring with higher incidence compared to placed was injection site reaction (P&lt;0.001).<sup>1,2</sup></p>
<h2>PRALUENT: the only PCSK9i with the option of a once-monthly single injection<sup>2</sup></h2>

<p>The usability and LDL-C reduction of the PRALUENT pen was assessed in the SYDNEY Device trial, and the following information is related to the ease-of-use associated with the PRALUENT pen.<sup>3</sup></p>
<h3>PRALUENT reaffirmed rapid and sustained LDL-C reduction with the once-monthly pen<sup>3</sup></h3>
<h4><strong>SYDNEY Device (once-monthly pen) Study:</strong></h4>
<p>A 16-week multicentre, randomised, open-label study in the US with 69 hypercholesterolaemia patients despite receiving statin with or without other lipid-lowering therapy randomly received supervised, self-administered PRALUENT.<sup>3</sup></p>
<h4><strong>Patients were randomised to receive either:</strong></h4>
<ul>
 <li>Self-administered SYDNEY device 1 x 300 mg injection (n=35) or auto injector 2 x 150 mg (n=34)<sup>3</sup></li>
 <li>The primary endpoint was PTC, which was measured at a rate of 0.5% (n=1) (95% CI, 0.0%–3.2%) during unsupervised injections and was not related to the device<sup>3****</sup></li>
</ul>
<p>For their first dose, patients received supervised, self-administered alirocumab 300 mg via 1 x 300 mg injection with the SYDNEY device (n=35) or 2 x 150 mg injections with the currently approved AI (n=34). All continuing patients subsequently received unsupervised, self-administered alirocumab 300 mg Q4W using the SYDNEY device at Weeks 4, 8, and 12.<sup>3</sup></p>
<h3 style="text-align: center;">Mean LDL-C reduction from baseline at week 4 was 66.2% with the SYDNEY device<sup>3</sup></h3>

<p data-font="small" style="text-align: center;">Adapted from Frias et al. 2020.<sup>3</sup></p>

DYSLIPIDEMIA

CARDIOLOGY

<p>Click here to read more about how to use PRALUENT</p>

<h3>PRALUENT offers you and your patients a user-friendly device<sup>3</sup></h3>

<h2>More information</h2>
<h3>Click a link below to learn more about PRALUENT</h3>

<h3>What is PRALUENT?</h3>
<p><a href="${link:{uuid:{9ce27534-1a2a-4ba1-8282-9b67a9256cdb},repository:{articles},path:{/Netherlands/what-is-praluent}}}">Click here</a>&nbsp;to learn about how PRALUENT works and who it is for</p>

<h3>How to use PRALUENT?</h3>
<p><a href="${link:{uuid:{c39077de-e6a2-4df7-a397-86cd8f1427cf},repository:{articles},path:{/Netherlands/how-to-use-praluent}}}">Click here</a>&nbsp;to learn more about how PRALUENT should be used</p>

<h2>Indication, Dosing, and Footnotes</h2>

PRALUENT indication

Dosing information and Footnotes

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The usual starting dose for PRALUENT is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (&gt;60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.<sup>2</sup>

Why choose PRALUENT®?

<p>PRALUENT is a PCSK9i that reduces the levels of LDL-C in the blood.<sup>2</sup>&nbsp;It is a fully human IgG1 monoclonal antibody that works by inhibiting the binding of PCSK9 to LDL- receptors. As a result, PRALUENT increases the number of LDL-receptors available to clear LDL, thereby lowering LDL-C levels.<sup>2</sup>&nbsp;Elevated LDL-C levels have been significantly associated with cardiovascular disease such as heart attacks and strokes.<sup>1</sup></p>
<h2>Praluent Indication</h2>
<h3>Primary hypercholesterolaemia and mixed dyslipidaemia<sup>1</sup></h3>
<p>PRALUENT<sup>®</sup>&nbsp;is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:</p>
<ul>
 <li>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,</li>
 <li>alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.</li>
</ul>
<h3>Established atherosclerotic cardiovascular disease<sup>1</sup></h3>
<p>PRALUENT<sup>®</sup>&nbsp;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:</p>
<ul>
 <li>in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,</li>
 <li>alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.</li>
</ul>

<h2>Dosing information</h2>
<h3>Adults<sup>2</sup></h3>
<p>Prior to initiating PRALUENT 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 (&gt;60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.</p>
<p>The dose of PRALUENT 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).</p>
<p>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.</p>
<h3>HeFH in paediatric patients 8 years of age and older:<sup>2</sup></h3>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
  <tr>
   <td style="color: #08A6CA;">
    <h4><strong>Body weight of patients</strong></h4></td>
   <td style="color: #08A6CA;">
    <h4><strong>Recommended dose</strong></h4></td>
   <td style="color: #08A6CA;">
    <h4><strong>Recommended dose if additional LDL-C reduction is needed*</strong></h4></td>
  </tr>
  <tr>
   <td>Less than 50 kg</td>
   <td>150 mg once every 4 weeks</td>
   <td>75 mg once evry 2 weeks</td>
  </tr>
  <tr>
   <td>50 kg or more</td>
   <td>300 mg once every 4 weeks</td>
   <td>150 mg once every 2 weeks</td>
  </tr>
 </tbody>
</table>
<p data-font="small">Adapted from PRALUENT<sup>®</sup> Summary of Product Characteristics. 2023.<sup>2</sup><br>
  * Lipid levels can be assessed 8 weeks after treatment intiation or titration and dose adjusted accordingly.<sup>2</sup></p>
<p>If a dose is missed, the dose should be administered as soon as possible and thereafter, dosing should be resumed on the original schedule.</p>

<h2>Mechanism of action</h2>
<h3>PRALUENT increases the number of LDL receptors, which thereby reduces LDL-cholesterol levels. Here’s how:<sup>2</sup></h3>

<p style="margin-bottom:11px"><strong>PRALUENT<sup>®</sup>: a powerful PCSK9i that ticks all the boxes<sup>1–4</sup></strong></p>

What is PRALUENT®?

<h3>Why choose PRALUENT?</h3>
<p><a href="https://d2b918c201921t.cloudfront.net/be/news/cardiology/dyslipidemie/ar/why-choose-praluent">Click here</a>&nbsp;to learn more about the efficacy and safety profile of PRALUENT</p>

PRALUENT<sup>®</sup>: a powerful PCSK9i that ticks all the boxes<sup>1–4</sup>

<h2>PRALUENT is available as a unique,<sup>¥</sup>&nbsp;once-monthly pen for your patients requiring &gt;60% LDL-C reduction<sup>2,3</sup></h2>

<h2>PRALUENT can be administered in 4 simple steps<sup>2</sup></h2>

<ol>
 <li>Press the pre-filled pen onto the skin at a 90° angle</li>
</ol>

<ol>
 <li>Hold this position untel the inspection window is completely yellow</li>
</ol>

<ol>
 <li>Remove the pre-filled pen from the skin</li>
</ol>

<p data-font="small">See full instructions for use</p>

PRALUENT is available as a unique,¥ once-monthly pen

<h2>ACS patients at very high risk – remember 146<sup>*1</sup></h2>
<p>The 2019 ESC/EAS dyslipidaemia guidelines recommend that post-ACS patient achieve an LDL-C value of less than 1.4 mmol/L.</p>
<p>Lipids levels should be reassessed 4-6 weeks after an ACS event, and if the target is not met, lipid-lowering treatments should be adjusted accordingly.</p>
<h4><strong>Did you know there is a very simple way to remember this for patients at very high CV risk?<sup>1†</sup></strong></h4>

<p>To reach the &lt;1.4 mmol/L LDL-C goal the ACVC/EAPC/ESC propose a strike early and strong approach to post-ACS LDL-C lowering:<sup>1,2‡</sup></p>

<ul>
 <li><strong>Initiate combination LLT</strong> with a statin + ezetimibe as soon as possible post-ACS</li>
 <li><strong>Consider the addition of a PCSK9i in the acute phase</strong>, particularly in ACS patients with high-risk features.</li>
</ul>

<p>Following the latest guidelines, for your patients at very high CV risk, remember <strong>146</strong>.<sup>1*</sup></p>

146 for Lipid Management After ACS

<h2>Session overview: New ESC Guidelines [30 Aug 2024]<sup>1</sup></h2>
<p>The 2024 ESC Guidelines for chronic coronary syndrome (CCS) update the previous 2018 ESC/European Association for Cardio-Thoracic Surgery (EACTS) guidelines regarding myocardial revascularization, as well as the 2019 ESC guidelines that are also endorsed by EACTS. These guidelines propose a structured, stepwise approach for managing CCS patients that includes four key steps: an initial clinical assessment, further cardiac evaluations, diagnostic testing, and modifications to lifestyle and risk factors, including medication. Importantly, the new guidelines redefine CCS to encompass a wider range of clinical presentations stemming from both structural and functional abnormalities within the macro- and microvascular systems. This revised definition includes conditions that may cause angina and ischemia even in patients with non-obstructive coronary arteries (ANOCA) and ischemia with non-obstructive coronary arteries (INOCA). The 2024 guidelines encourage the use of a risk factor- weighted clinical likelihood model to determine the pretest likelihood of obstructive coronary artery disease (CAD).</p>
<h2>Key findings</h2>
<p>The newly introduced prediction model is capable of classifying up to 50% of patients as having a very low likelihood of obstructive CAD, potentially leading to a deferral of further diagnostic testing. However, it is essential that this model be adapted based on clinical information, and the ultimate diagnosis must be a clinical decision that integrates all relevant data.</p>
<p>For each patient suspected of having CCS, a lipid profile—including total cholesterol, high-density lipoprotein cholesterol (HDL-C), and triglycerides, which allows for the calculation of LDL-C—should be obtained to diagnose comorbidities and to inform treatment strategies.</p>
<p>Routine assessments should include the lipid profile with LDL-C (IA), a complete blood count (including hemoglobin) (IB), creatinine levels with an estimation of renal function (IB), and an evaluation of glycemic status through HbA1c and/or fasting plasma glucose (IB).<br>
  In patients suspected of having CCS, it is advisable to evaluate thyroid function at least once (IB).</p>
<p>Consideration should also be given to measuring high-sensitivity C-reactive protein and/or fibrinogen plasma levels (IIaB).</p>
<p>For patients with established ASCVD, reducing LDL-C levels is effective in lowering the risk of recurrent major adverse cardiovascular events (MACE).</p>

<h2>Recommendations on lipid-lowering therapy (LLT) for patients with CCS</h2>

<p data-font="small"><em>New recommendations are highlighted in the below grey boxes</em></p>

<ul>
 <li>It is recommended to implement lipid-lowering treatment targeting an LDL-C level of &lt;1.4 mmol/L (55 mg/dL) and achieving a reduction of ≥50% in LDL-C compared to baseline (new recommendation; IA).</li>
</ul>

<ul>
 <li>A high-intensity statin should be administered at the highest tolerated dose to meet LDL-C goals for all patients with CCS (IA).<br>
   &nbsp;</li>
 <li>If a patient's goals are not met with the maximum tolerated dose (MTD) of statin, the incorporation of ezetimibe is suggested (IB).</li>
</ul>

<ul>
 <li>For patients who cannot tolerate statins and do not reach their goals with ezetimibe, the addition of bempedoic acid is recommended (new recommendation; IB).</li>
</ul>

<ul>
 <li>For patients who fail to achieve their target with MTD of statin and ezetimibe, combining treatment with a PCSK9 inhibitor is advised (IA).</li>
</ul>

<ul>
 <li>In cases where patients do not meet their goals with MTD of statin and ezetimibe, the addition of bempedoic acid should be considered (new recommendation; IIaC).</li>
</ul>

<ul>
 <li>For patients experiencing a recurrent atherothrombotic event (which may differ from the original event) while on maximally tolerated statin therapy, targeting an LDL-C level of &lt;1.0 mmol/L (&lt;40 mg/dL) may be an option (IIbB).</li>
</ul>

<h2>SGLT2 inhibitors and/or GLP-1 receptor agonists in patients with CCS</h2>
<ul>
 <li>SGLT2 inhibitors with established cardiovascular benefits are recommended for patients with type 2 diabetes (T2D) and CCS to reduce CV events, regardless of baseline or target HbA1c and independent of other glucose-lowering medications (IA).<br>
   &nbsp;</li>
 <li>Semaglutide should be considered for CCS patients who do not have diabetes but are overweight or obese (BMI &gt;27 kg/m2) to help reduce risk of cardiovascular mortality, myocardial infarction (MI), or stroke (IIaB).</li>
</ul>
<h2>Update on the following Recommendation</h2>

<p data-font="small"><em>Revised recommendation is highlighted in bold below</em></p>

<p>Previously, statins were recommended for all patients with CCS (IA). <strong>A high-intensity statin at the highest tolerated dose to achieve LDL-C goals remains recommended for all CCS patients (IA).</strong></p>
<h2>Key messages</h2>

<p>The guidelines advocate for a multidisciplinary strategy to ensure comprehensive management, focusing on non- invasive diagnostic methods, proactive LDL-C reduction, and revascularization for patients with chronic coronary syndrome (CCS) who are at high risk. The importance of lipid testing is also underscored.</p>
<p>The recommended LDL-C target is consistent with the 2019 ESC/EAS Guidelines for dyslipidaemia management as well as the 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice.</p>
<p>It is advisable to consider the addition of PCSK9 inhibitors for patients who do not reach the guideline- recommended LDL-C targets, even with maximally tolerated doses of statins and ezetimibe.</p>

<p data-font="small">WANT TO KNOW MORE ABOUT ACS CARE?</p>

Felicita Andreotti, Italy; Christiaan J M Vrints, Belgium

2024 ESC Guidelines for the management of chronic coronary syndromes

<h2>Vergoedingsvoorwaarden Praluent<sup>®</sup> (alirocumab)</h2>
<p>Uitsluitend voor een verzekerde met hypercholesterolemie (familiaire en niet-familiaire) en met een voldoende hoog risico, indien de maximaal verdraagbare orale lipidenverlagende therapie van een statine en ezetimib niet de LDL-C streefwaarde bereikt conform de vigerende cardiovasculair risicomanagement (CVRM)-richtlijn, kan alirocumab worden ingezet als volgt:</p>
<ol>
 <li>in combinatie met zowel een statine als ezetimib in een maximaal verdraagbare dosering, of<br>
   &nbsp;</li>
 <li>in combinatie met enkel ezetimib<sup>*</sup> in een maximaal verdraagbare dosering, indien er sprake is van gedocumenteerde statine-intolerantie: statinegeassocieerde spierpijn voor tenminste drie verschillende statines vastgesteld volgens het stroomschema en de criteria beschreven door EAS/ESC consensus (European Heart Journal 2015; 36: 1012-1022).</li>
</ol>

<p>Patiënten met hypercholesterolemie met een voldoende hoog risico zijn gedefinieerd als één van onderstaande groepen:</p>
<ol>
 <li>heterozygote familiaire hypercholesterolemie patiënten, of<br>
   &nbsp;</li>
 <li>patiënten met een zeer hoog cardiovasculair risico vanwege vastgestelde hart-en-vaatziekten zoals gedefinieerd in de vigerende CVRM-richtlijn.</li>
</ol>

<p data-font="small"><sup>*</sup>Er is sprake van een ezetimib intolerantie (maximaal verdraagbare dosering is 0 mg) indien na minstens 4 weken onoverkomelijke bijwerkingen van ezetimib blijven bestaan.</p>

<h2>Artsenverklaring</h2>
<p>De controle op deze voorwaarden is de verantwoordelijkheid van de zorgverzekeraars en gaat via een artsenverklaring. Naast het recept voor Praluent dient ook de artsenverklaring ingevuld te worden.</p>
<p>Op welke manieren kunt de Praluent artsenverklaring het gemakkelijkst invullen?</p>

<h2>Indicatie</h2>
<p>Meer weten over de indicatie, dosering, de wijze van toediening of de bijwerkingen?</p>

Praluent is sinds 1 juni 2016 onder nadere voorwaarden vanuit de basisverzekering vergoed. Deze voorwaarden zijn vastgelegd in Bijlage 2 van de regeling zorgverzekering.

Vergoeding Praluent

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