The management of heterozygous familial hypercholesterolaemia with high lipoprotein (a) and statin intolerance. The guidelines a mirage?

Pino, Beatrice Dal; Bigazzi, Federico; Sbrana, Francesco; Sampietro, Tiziana

doi:10.1177/2047487320905727

Cited by 1 publication

(1 citation statement)

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“…Furthermore, the high frequency of flu-like syndrome (21% of AEs) can be managed by administering paracetamol, shifting PCSK9i drugs or starting inclisiran therapy. 23 This study, despite some limitations such as the high prevalence of patients from the same enrolment site and no analysis regarding other pharmacological therapies modification (as antiplatelet therapy) that could have influenced the MACE events, had the strength of relative longterm follow-up and the clinical end point analysis. Nowadays we know that preventing one patient from MACE needed to treat 36 patients with PCSK9i for 1.56 years 24 and our own data cover one of the first multicentre, realword, long-term reported experiences with PCSK9i therapy in which MACE events were analysed.…”

Section: Discussionmentioning

confidence: 99%

Major cardiovascular events increase in long-term proprotein convertase subtilisin/kexin type 9 inhibitors therapy: the Tuscany cost-effective study

Sbrana,

Dal Pino,

Bigazzi

et al. 2023

Journal of Cardiovascular Medicine

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Background Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) represent a breakthrough in the treatment of hypercholesterolemia. The aim of this study was to perform a multicentre prospective analysis on the effects of PCSK9i since their distribution in Italy. Methods During the study period (July 2017 to February 2022) 246 patients (mean age 61 ± 11 years, male 73%) who were evolocumab (142/246) or alirocumab (104/246) new users were enrolled in the CERTI (Costo Efficacia Regione Toscana Inibitori PCSK9) study. Lipid value, adverse events (AEs), major cardiovascular events (MACEs) and intima-media thickness were analysed. Results PCSK9i therapy allowed a significant improvement in patients’ lipid profile [total cholesterol −35%, P < 0.001; triglycerides −9%, P < 0.05; low-density lipoprotein (LDL) cholesterol −51%, P < 0.001; Lp(a) levels −4%, P < 0.05], maintained during the follow-up. No significant variations in intima-media thickness were observed. In the subgroup of patients with more than 1 year of PCSK9i therapy (165/246 patients) we highlighted: a 66% reduction in MACEs compared with the year before recruitment; a progressive increase in MACEs during the follow-up (MACEs event/rate at first year 0.08 vs. MACEs event/rate at year 5: 0.47); a patients cluster with late MACEs older, with higher prevalence of hypertension, smoking habit and peripheral vascular disease. During the follow-up, we recorded AEs in 31% of patients, which mainly resulted in reduction/discontinuation of lipid-lowering therapy for 50 patients or in discontinuation/shift of PCSK9i (respectively 8 and 6 cases). Conclusion Our data agree with the large evidence on the effectiveness/tolerability of PCSK9i therapy; however, although PCSK9i represents a good cholesterol-lowering therapeutic option, our study shows a progressive increase in MACEs during the late follow-up that deserve further research.

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Section: Discussionmentioning

confidence: 99%