<h2>Main Takeaway</h2>
<p><strong>The rate of prescription of PCSK9i therapy was below expectations during the first year of availability</strong>&nbsp;in patients from the Tuscany region who had a prior CV event or had a comorbidity that increases CV risk</p>
<p>During first 6 months of follow-up,&nbsp;<strong>adherence and persistence to PCSK9i therapy were very satisfying</strong>, highlighting good tolerance and treatment compliance</p>
<h2>Why This Matters</h2>
<p>Italian Medicines Agency follows strict reimbursement criteria imposing a potential barrier to PCSK9i access, and this could have generated inequalities in the prescribing governance across Italian regions</p>
<h2>Study Design</h2>
<p>This Italian, real-world study included 269 patients from 26 specialized centers in Tusc any region who had:</p>
<ul>
 <li>a prior CV event or had a comorbidity that increases CV risk</li>
 <li>received at least one PCSK9i prescription (evolocumab or alirocumab) from July 2017 to June 2018</li>
</ul>
<p><strong>Lipid-lowering therapy (LLT) prescriptions</strong>&nbsp;in the 6 months before the index date (date of first PCSK9i dispensing) were analyzed based on the outpatient prescription database retrieved from the healthcare administrative databases</p>
<p><strong>Key inclusion criteria:</strong></p>
<ul>
 <li>adherence (proportion of days covered [PDC])</li>
 <li>persistence (absence of a gap longer than 30 days between end of dispensing duration and new dispensing period or end of follow-up)</li>
 <li>switch between different PCSK9is</li>
</ul>
<h2>Key Results</h2>
<h3>Patient population</h3>
<ul>
 <li>Overall, 269 new users of PCSK9i were included in the study: 
  <ul>
   <li>mean age = 59.1 years</li>
   <li>males = 71.0%</li>
   <li>primary prevention (N = 80), secondary prevention (N = 189)</li>
   <li>evolocumab (N = 176), alirocumab (N = 93)</li>
   <li>≥ 1 clinical condition increasing CV risk (N = 184) (most common: familial hypercholesterolemia (N = 144), diabetes mellitus (N = 66)</li>
  </ul></li>
 <li>The rate of PCSK9i prescription was&nbsp;<strong>7.2 per 100,000 inhabitants</strong></li>
 <li>In 6 months prior to first PCSK9i dispensing period,&nbsp;<strong>61.3% of the patients received at least one prescription of LLT included in reimbursement criteria</strong>&nbsp;(ezetimibe with/without high-intensity statin), whereas 16.4% of the patients received other LLTs and 22.3% of the patients had no LLT recorded</li>
</ul>
<h3>Outcomes</h3>
<ul>
 <li>Adherence:&nbsp;<strong>More than 80% of patients were adherent to therapy</strong>&nbsp;(PDC ≥75%) 
  <ul>
   <li>Similar trend for adherence to therapy was observed for evolocumab (80.6%) and alirocumab (79.1%)</li>
  </ul></li>
 <li>Persistence: During follow-up,&nbsp;<strong>73.3% of PCSK9i users</strong>&nbsp;(72.6% for evolocumab and 74.7% for alirocumab)&nbsp;<strong>were persistent to therapy for 6 months</strong>
  <ul>
   <li>Following a PCSK9i discontinuation, 19.2% of patients restarted therapy (primary vs secondary prevention: 20.6% vs 16.5%)</li>
  </ul></li>
 <li>Switch:&nbsp;<strong>Only one patient switched from evolocumab to alirocumab</strong></li>
</ul>
<h2>Limitations</h2>
<ul>
 <li>Lack of clinical information like LDL-C levels or statin intolerance did not permit to confirm the precise fulfilment of reimbursement criteria</li>
 <li>Enrollment of some subjects in the study post participation in a clinical trial could have resulted in misclassification of these participants as “new PCSK9i users”</li>
 <li>Adherence and persistence to PCSK9i therapy was evaluated for a short period</li>
</ul>
<ul>
</ul>

Italian real-world analysis on management and pattern of PCSK9 inhibitor use in the first six months of treatment

Italian real-world analysis for PCSK9 inhibitors new users

DYSLIPIDEMIA

CARDIOLOGY

THROMBOSIS

No Rebound Effect Post Clopidogrel Withdrawal

<p>Watch the video of subgroup analysis of the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events (CHANCE) trial showed no rebound increase in the risk of ischemic stroke, stroke, transient ischemic attack (TIA), and composite events during the 90 days after discontinuation of clopidogrel therapy in patients with TIA or minor stroke.</p>

Effectiveness and safety of Clopidogrel vs Aspirin

<p>Watch the video and get to know more on how Clopidogrel is a safe and effective alternative to Aspirin as an Antiplatelet agent for secondary prevention of stroke in patients aged over 80 years.</p>

<h2>2019 ESC/EAS Guidelines for the management of Dyslipidaemias: lipid modification to reduce cardiovascular risk</h2>

<table border="1" cellpadding="10" cellspacing="1">
 <tbody>
  <tr>
   <td style="width: 76%; background-color: rgb(244, 242, 247);">Recommendations</td>
   <td style="width: 12%; background-color: rgb(244, 242, 247);">Class a</td>
   <td style="width: 12%; background-color: rgb(244, 242, 247);">Level b</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>CVD risk estimation</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">Total risk estimation using a risk estimation system such as SCORE is recommended for asymptomatic adults aged &gt;40 years without evidence of CVD, DMCKD, FH, or LDL &gt;4.9 mmol/L (&gt;190 mg/dL).</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">High- and very-high-risk individuals may be identified on the basis of documented CVD, DM, moderate-to-severe renal disease, very high levels of individual risk factors, FH, or a high SCORE risk, and are a priority for advice and management of all risk factors.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">Risk scores developed for the general population are not recommended for CV risk assessment in patients with DM or FH.</td>
   <td style="width: 12%;">III</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Lipid analyses for CVD risk estimation</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">TC is to be used for the estimation of total CV risk by means of the SCORE system.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">HDL-C analysis is recommended to further refine risk estimation using the online SCORE system.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">LDL-C analysis is recommended as the primary lipid analysis method for screening, diagnosis, and management.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">TG analysis is recommended as a part of the routine lipid analysis approach.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">Non-HDL-C evaluation is recommended for risk assessment, particularly in people with high TG levels, DM, obesity, or very low LDL-C levels.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">ApoB analysis is recommended for risk assessment, particularly in people with high TG levels, DM, obesity, or MetS, or very low LDL-C levels. It can be used as an alternative to LDL-C, if available, as the primary measurement for screening, diagnosis, and management, and may be preferred over non-HDL-C in people with high TG levels, DM, obesity, or very low LDL-C levels.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Treatment goals for LDL-C</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">In secondary prevention for patients at very-high risk,anLDL-Creduction of&gt;_50% from baseline and an LDL-C goal of &lt;1.4 mmol/L(&lt;55 mg/dL) are recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">In primary prevention for individuals at very-high risk, an LDL-C reduction of&gt;_50% from baseline and an LDL-C goal of &lt;1.4 mmol/L(&lt;55 mg/dL) are recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">In patients at high risk, an LDL-C reduction of &gt;_50% from baseline and an LDL-C goal of &lt;1.8 mmol/L (&lt;70 mg/dL) are recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Pharmacological LDL-C lowering</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that a high-intensity statin is prescribed up to the highest tolerated dose to reach the goals set for the specific level of risk.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">If the goals are not achieved with the maximum tolerated dose of a statin, combination with ezetimibe is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">B</td>
  </tr>
  <tr>
   <td style="width: 76%;">For secondary prevention in patients at very-high risk not achieving their goal on a maximum tolerated dose of a statin and ezetimibe, a combination with a PCSK9 inhibitor is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">For very-high-risk FH patients (that is, with ASCVD or with another major risk factor) who do not achieve their goal on a maximum tolerated dose of a statin and ezetimibe, a combination with a PCSK9 inhibitor is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Drug treatment of patients with HTG</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">Statin treatment is recommended as the first drug of choice for reducing CVD risk in high-risk individuals with HTG [TGs &gt;2.3 mmol/L(&gt;200mg/dL)].</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">B</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Management of patients with HeFH</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that a diagnosis of FH is considered in patients with CHD aged&lt;55 years for men and &lt;60 years for women, in people with relatives with premature fatal or non-fatal CVD, in people with relatives having tendon xanthomas, in people with severely elevated LDL-C levels [in adults &gt;5 mmol/L (&gt;190 mg/dL), in children &gt;4 mmol/L (&gt;150 mg/dL)], and in first-degree relatives of FH patients.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that FH is diagnosed using clinical criteria and confirmed, when possible, with DNA analysis.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">Once the index case is diagnosed, family cascade screening is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that FH patients with ASCVD or who have another major risk factor are treated as very-high-risk, and those with no prior ASCVD or other risk factors as high-risk.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">For FH patients with ASCVD who are at very-high risk, treatment to achieve a ≥ 50% reduction from baseline and an LDL-C &lt;1.4mmol/L (&lt;55mg/dL)is recommended. If goals cannot be achieved, a drug combination is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">Treatment with a PCSK9inhibitor is recommended in very-high risk FH patients if the treatment goal is not achieved on a maximal tolerated statin plus ezetimibe.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">In children, testing for FH is recommended from the age of 5 years, or earlier if HoFH is suspected.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Treatment of Dyslipidaemias in older people</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">Treatment with statins is recommended for older people with ASCVD in the same way as for younger patients.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">Treatment with statins is recommended for primary prevention, according to the level of risk, in older people aged ≤ 75 years.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that the statin is started at a low dose if there is significant renal impairment and/or the potential for drug interactions, and then titrated upwards to achieve LDL-C treatment goals.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Treatment of Dyslipidaemias in DM</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">In patients with T2DM at very-high risk, an LDL-C reduction of ≥ 50% from baseline and an LDL-C goal of &lt;1.4 mmol/L (&lt;55 mg/dL) is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">In patients with T2DM at high risk, an LDL-C reduction of ≥ 50% from baseline and an LDL-C goal of &lt;1.8 mmol/L (&lt;70 mg/dL) is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">Statins are recommended in patients with T1DM who are at high or very-high risk.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">Statin therapy is not recommended in pre-menopausal patients with or without DM who are considering pregnancy, or not using adequate contraception.</td>
   <td style="width: 12%;">III</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Management of patients with ACS</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">In all ACS patients without any contraindication or definite history of intolerance, it is recommended that high-dose statin therapy is initiated or continued as early as possible, regardless of initial LDL-C values.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">If the LDL-C goal is not achieved after 4-6 weeks with the maximally tolerated statin dose, combination with ezetimibe is recommended.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">B</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Lipid-lowering therapy for prevention of ASCVD events in patients with prior ischaemic stroke</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">Patients with a history of ischaemic stroke or TIA are at very-high risk of ASCVD, particularly recurrent ischaemic stroke, so it is recommended that they receive intensive LDL-C-lowering therapy.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Treatment of dyslipidaemias in chronic HF or valvular heart diseases</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">Initiation of lipid-lowering therapy is not recommended in patients with HF in the absence of other indications for their use.</td>
   <td style="width: 12%;">III</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">Initiation of lipid-lowering treatment is not recommended in patients with aortic valvular stenosis without CAD to slow progression of aortic valve stenosis in the absence of other indications for their use.</td>
   <td style="width: 12%;">III</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Lipid management in patients with moderate-to-severe (Kidney disease outcomes quality initiative stages 3-5) CKD</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that patients with stage 3-5 CKD are considered to be at high or very-high risk of ASCVD.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">The use of statins or statin/ezetimibe-combination is recommended in patients with non-dialysis-dependent stage 3-5 CKD.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">In patients with dialysis-dependent CKD who are free of ASCVD, commencement of statin therapy is not recommended</td>
   <td style="width: 12%;">III</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Lipid-lowering drugs in patients with PAD(including carotid artery disease)</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">In patients with PAD, lipid-lowering therapy—including a maximum tolerated dose of a statin, plus ezetimibe, or a combination with a PCSK9 inhibitor if needed—is recommended to reduce the risk of ASCVD events.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">A</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Lipid-lowering drugs in patients with CIID</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">The use of lipid-lowering drugs only on the basis of the presence of CIID is not recommended.</td>
   <td style="width: 12%;">III</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">
    <h3><strong>Lipid-lowering drugs in patients with SMI</strong></h3></td>
   <td style="width: 12%;">&nbsp;</td>
   <td style="width: 12%;">&nbsp;</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that SMIs are used as modifiers for estimating total ASCVD risk.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that the same guidelines for the management of total ASCVD risk are used in patients with SMI as are used in patients without such disease.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
  <tr>
   <td style="width: 76%;">It is recommended that in patients with SMI, intensified attention is paid to adherence to lifestyle changes and to compliance with drug treatment.</td>
   <td style="width: 12%;">I</td>
   <td style="width: 12%;">C</td>
  </tr>
 </tbody>
</table>

<p data-font="legal">ᵃClass of recommendation.<br>
  ᵇLevel of evidence.</p>

Abbreviations

References

ESC/EAS 2019 Guidelines for the management of dyslipidaemias

DAPT in Elderly with CAD Meta Analysis

<p>Watch the video and get to know more on the crucial insights from this systematic review and meta-analysis of DAPT in elderly patients with acute coronary syndrome (ACS). Dual oral antiplatelet therapy (DAPT) with prasugrel or ticagrelor is associated with a higher risk of bleeding events in elderly patients with ACS compared to clopidogrel, with no difference in primary efficacy endpoint rates between the treatment groups.</p>

Understanding de-escalation in Antiplatelet therapy

<p>Watch the video of Prof. Thomas Cuisset M.D, Ph.D, Interventional Cardiology Unit and Head of the Cathlab in University Hospital, La Timone, Marseille, France where he explains The de-escalation strategy and which patients are good candidates for proactive de-escalation.</p>

<h2>Effect of alirocumab on major adverse cardiovascular events according to renal function in patients with a recent acute coronary syndrome: prespecified analysis from the Odyssey Outcomes randomized clinical trial.</h2>
<p>José Tuñón, Philippe Gabriel Steg, Deepak L Bhatt, Vera A Bittner, Rafael Díaz, Shaun G Goodman, J Wouter Jukema, Yong-Un Kim, Qian H Li, Christian Mueller, Alexander Parkhomenko, Robert Pordy, Piyamitr Sritara, Michael Szarek, Harvey D White, Andreas M Zeiher, Gregory G Schwartz, for the Odyssey outcomes investigators</p>
<h2>Objective</h2>
<p>This prespecified analysis of the Odyssey Outcomes trial examined whether the reduction of major adverse cardiovascular events (MACE) with alirocumab, added to intensive or maximum-tolerated statin therapy after Acute Coronary Syndrome (ACS), depends upon the level of estimated glomerular filtration rate (eGFR).</p>
<h2>Methods</h2>
<p>The trial was a randomized, double-blind, placebo-controlled comparison of alirocumab or placebo in 18,918 patients with an ACS (myocardial infarction or unstable angina) 1–12months before randomization. Qualifying patients had persistent dyslipidemia [LDL-C≥ 70mg/dL (1.81mmol/L), nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100mg/dL (2.59mmol/L), or apolipoprotein B≥ 80mg/dL (0.0016mmol/L)] despite treatment with atorvastatin 40–80 mg daily, rosuvastatin 20–40mg daily, or the maximum-tolerated dose of one of these statins (including no statin in case of documented intolerance).</p>
<p>Participants were randomly assigned (1:1) to receive alirocumab 75mg or matching placebo subcutaneously every 2weeks. A treat-totarget design aimed to achieve an LDL-C level of 25–50mg/dL among alirocumab treated patients. Alirocumab 75mg was blindly up-titrated to 150mg if the LDL-C level was &gt;50mg/dL. If LDL-C was &lt;15mg/dL on two consecutive measurements on the 75mg dose of alirocumab, placebo was blindly substituted for the rest of the trial.</p>
<h2>Endpoints</h2>
<p>The primary outcome was a composite of MACE, including death due to coronary heart disease, non-fatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. Death from any cause was a secondary outcome. All outcomes were blindly adjudicated.</p>
<p>This prespecified analysis also investigated whether the effect of alirocumab on MACE and death varied across the range of baseline renal function, analyzed the incidence of adverse effects as a function of eGFR, and looked for potential effects of alirocumab on eGFR.</p>
<h2>Results</h2>
<p>A total of 18 924 patients underwent randomization; Of these, 9462 were assigned to alirocumab and 9462 to placebo.</p>
<p>Alirocumab decreased LDL-C by 62.2% and 48.5% vs. placebo at 4 and 36 months, respectively. Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization) with fewer deaths. There was no interaction between continuous eGFR and treatment on the primary outcome or death (P = 0.14 and 0.59, respectively). Alirocumab reduced primary outcomes in patients with eGFR ≥90mL/min/1.73 m2 (n = 7470; hazard ratio 0.784, 95% confidence interval 0.670–0.919; P = 0.003) and 60 to &lt;90 (n = 9326; 0.833, 0.731–0.949; P= 0.006), but not in those with eGFR&lt; 60 (n = 2122; 0.974, 0.805–1.178; P = 0.784). Adverse events other than local injection-site reactions were similar in both groups across all categories of eGFR.</p>
<h2>Conclusion</h2>
<p>In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR &gt; 60 mL/min/1.73 m2.</p>

Reference

Effect of Alirocumab on MACE in patients with CKD

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