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Real-world assessment of iPCSK9 treatment adherence, effectiveness, and tolerability: a preliminary analysis
Session:
Posters (Sessão 3 - Écran 5) - Risco Cardiovascular 1 - Lípidos e Hipertensão Arterial
Speaker:
Rita Amador
Congress:
CPC 2022
Topic:
J. Preventive Cardiology
Theme:
28. Risk Factors and Prevention
Subtheme:
28.4 Lipids
Session Type:
Pósters Electrónicos
FP Number:
---
Authors:
Rita r. Amador; Sérgio Maltês; Catarina Oliveira; Ana Rita Bello; Ana Micro; Fátima Falcão; Bruno ml Rocha; Jorge Ferreira; Miguel Mendes
Abstract
<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong>Background:</strong></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">High levels of low-density lipoprotein cholesterol (LDL-c) represent a major cardiovascular (CV) risk factor. Evolocumab, a recently approved PCSK9 inhibitor, is an important therapy in patients with high or very high CV risk who do not reach target LDL-c levels despite optimal therapy or who are intolerant to statins. Our goal was to assess real-word early data regarding evolocumab prescription, adherence, tolerability, and effectiveness. </span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong>Methods:</strong></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">Single-centre study enrolling consecutive patients prescribed evolocumab. An effectiveness analysis was conducted in patients with cholesterol levels obtained before and one year after PCSK9 inhibitor initiation. Patients undergoing LDL-c apheresis (n=2) were excluded from the effectiveness analysis. Safety data was obtained through active pharmacovigilance in patients under evolocumab for =3 months. Adherence to treatment (AT) was assessed using the Medication Possession Ratio (MPR). Those with an MPR =0.80 were considered adherent to therapy.</span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong>Results:</strong></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">A total of 34 patients were referred for evolocumab (mean age 64±9 years; 62% male; 85% with very high and 15% with high CV risk according to the ESC guidelines, 68% with confirmed familial forms of dyslipidaemia). The main prescription reason was inability to achieve an LDL-c <55mg/dL in very-high risk or <70mg/dL in high-risk patients despite optimal therapy (19 patients, 56%) followed by statin intolerance (15 patients, 44%). Patients who were not intolerant had been prescribed a high-intensity statin and ezetimibe. Four patients had yet to start treatment at the present time. After 12-months of evolocumab, median LDL-c was significantly lower (140 [125-149] vs. 48 [27-63]mg/dL, Wilcoxon signed-rank test p=0.005) as were total cholesterol levels (229 [202-240] vs. 125 [86-129]mg/dL, Wilcoxon signed-rank test p=0.008). During follow-up, 90% of patients had an LDL-c reduction equal to or higher than 50% (mean LDL-c reduction 65 ± 15%) at 12-months and 60% were able to meet the LDL-c target level. Ten patients (44%) had a suspected adverse drug reaction (ADR)-nine with mild ADRs and one with a severe ADR (anaphylaxis). The most frequent ADRs were arthralgia (n=4), lumbar pain (n=3) and myalgia (n=3). AT was evaluated in 21 patients - mean MPR was 0.95±0.11; 19 patients (91%) with an MPR =0.80. Two patients discontinued evolocumab due to ADRs.</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong>Conclusion:</strong></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif">In our real-word early experience regarding evolocumab, drug effectiveness was high and led to significant LDL and total cholesterol reductions. Evolocumab was associated with a high therapy adherence and severe ADR and drug discontinuation were rare. </span></span></p>
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