Efficacy and safety of proprotein convertase subtilisin/kexintype nine inhibitors in real life experience

Navarro-Hoyas, Clara; Moragrega, Raquel Miralles; Delegido-Gomez, Laura; López-Muñoz, Beatriz; Moreno-Pérez, Óscar; Pico-Alfonso, Antonio; González-Sánchez, Víctor

doi:10.1530/endoabs.56.p304

Cited by 1 publication

(3 citation statements)

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“…Randomized controlled clinical trials frequently enlarge the magnitude of LDL-C lowering rate due to rigorous patient monitoring and intensive lifestyle modifications [8][9][10][11][12][13][14] . Our study indicates a mean LDL-C reduction rate comparable with that of FOURIER and ODYSSEΥ clinical trials (approximately 60%) and similar with that achieved in real-life studies (50-63%) [20][21][22][23][24][25][26] . It also confirms that PSCK9i-related LDL-C reduction was sustained after 1 and 2 years on treatment with both evolocumab and alirocumab having comparable efficacy.…”

Section: Discussionsupporting

confidence: 86%

“…The present study is one of the few investigating the efficacy and safety of PCSK9i administration in a clinical real life setting [20][21][22][23][24][25][26] . Randomized controlled clinical trials frequently enlarge the magnitude of LDL-C lowering rate due to rigorous patient monitoring and intensive lifestyle modifications [8][9][10][11][12][13][14] .…”

Section: Discussionmentioning

confidence: 99%

“…Of note, 90% of our patients were treated with highintensity statins. Two previously published real-life cohorts reported treatment rates with high-intensity statin regiments in 49% and 66% of participants, respectively 23,26 . This discrepancy could be attributed to different PSCK9i approval criteria applicable in each country.…”

Section: Discussionmentioning

confidence: 99%

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PCSK9 inhibitors: The breakthrough lipid-lowering treatment at real-life setting – A 2-year regional lipid clinic experience

Anastasiou¹,

Liamis²,

Milionis³

et al. 2020

JAPT

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Aim: Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been demonstrated to be safe and effective in low-density lipoprotein cholesterol (LDL-C) lowering and cardiovascular risk reduction. Data on clinical implementation of PCSK9 inhibitors in real life setting in Greece is limited. Thus, we report 2-year experience with PCSK9 inhibitors in clinical practice at a University Hospital Lipid Clinic. Patients and methods: This is a retrospective study of patients who were first prescribed a PCSK9 inhibitor during 2016-2018. Patients had either established cardiovascular disease (CVD) and/or familial hypercholesterolemia (FH) and LDL-C level >100 mg/dL despite maximum tolerated high-intensity statin plus ezetimibe. Patient demographics, medical history, concomitant medications and laboratory results were documented during visits. Results: We included 37 patients (mean age 52 years, 56.8% males). Of patients, 28 (76%) had established CVD and 27 patients (74%) had FH. Concerning treatment, 33 patients (89%) were receiving high-intensity statin, while 35 patients (95%) were also on ezetimibe 10 mg. Addition of PCSK9 inhibitors (51% on evolocumab 140 mg per 2 weeks (Q2W), 22% on alirocumab 75 mg Q2W and 27% on alirocumab 150 mg Q2W) resulted in a reduction of total cholesterol by 42% and LDL-C by 59% after 2 months (p<0.05). These reductions remained unchanged after 1 and 2 years on treatment. Thirty patients (81%) achieved LDL-C treatment goal following PCSK9i treatment. Four patients (11%) developed minor adverse effects. No treatment discontinuation was reported. Conclusion: In real-life setting addition of PCSK9 inhibitors to maximally tolerated lipid-lowering therapy resulted in reductions of LDL-C levels of the magnitude seen in clinical studies. These reductions were sustainable during a 2-year follow-up.

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