<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

<p>Heeft u vragen of wilt u meer weten? Wij zorgen dat u zo snel mogelijk geholpen wordt.</p>


Wij staan klaar

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®?

<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

<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>

<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®?

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

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<p>Campus Sanofi is het platform voor beroepsbeoefenaren&nbsp;en biedt één plek om informatie te vinden over onze ziekte- en therapeutische gebieden; productinformatie, relevante artikelen, podcasts, webinars, evenementen en andere bronnen om discussies met patiënten te vergemakkelijken.</p>
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