Improved lipid-lowering treatment and reduction in cardiovascular disease burden in homozygous familial hypercholesterolemia: The SAFEHEART follow-up study

Atherosclerosis. 2024 Jun:393:117516. doi: 10.1016/j.atherosclerosis.2024.117516. Epub 2024 Mar 16.

Abstract

Aim: We aimed to describe clinical and genetic characteristics, lipid-lowering treatment and atherosclerotic cardiovascular disease (ASCVD) outcomes over a long-term follow-up in homozygous familial hypercholesterolemia (HoFH).

Methods: SAFEHEART (Spanish Familial Hypercholesterolaemia Cohort Study) is a long-term study in molecularly diagnosed FH. Data analyzed in HoFH were prospectively obtained from 2004 until 2022. ASCVD events, lipid profile and lipid-lowering treatment were determined.

Results: Thirty-nine HoFH patients were analyzed. The mean age was 42 ± 20 years and nineteen (49%) were women. Median follow-up was 11 years (IQR 6,18). Median age at genetic diagnosis was 24 years (IQR 8,42). At enrolment, 33% had ASCVD and 18% had aortic valve disease. Patients with new ASCVD events and aortic valve disease at follow-up were six (15%), and one (3%), respectively. Median untreated LDL-C levels were 555 mg/dL (IQ 413,800), and median LDL-C levels at last follow-up was 122 mg/dL (IQR 91,172). Most patients (92%) were on high intensity statins and ezetimibe, 28% with PCSK9i, 26% with lomitapide, and 23% with lipoprotein-apheresis. Fourteen patients (36%) attained an LDL-C level below 100 mg/dL, and 10% attained an LDL-C below 70 mg/dL in secondary prevention. Patients with null/null variants were youngers, had higher untreated LDL-C and had the first ASCVD event earlier. Free-event survival is longer in patients with defective variant compared with those patients with at least one null variant (p=0.02).

Conclusions: HoFH is a severe life threating disease with a high genetic and phenotypic variability. The improvement in lipid-lowering treatment and LDL-C levels have contributed to reduce ASCVD events.

Trial registration: ClinicalTrials.gov NCT02693548.

Keywords: Aortic valve disease; Cardiovascular disease; Ezetimibe; Homozygous familial hypercholesterolemia; Lipoprotein-apheresis; Lomitapide; PCSK9 inhibitors; Statins.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anticholesteremic Agents* / therapeutic use
  • Biomarkers / blood
  • Cholesterol, LDL* / blood
  • Ezetimibe / therapeutic use
  • Female
  • Follow-Up Studies
  • Homozygote*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Hyperlipoproteinemia Type II* / blood
  • Hyperlipoproteinemia Type II* / complications
  • Hyperlipoproteinemia Type II* / drug therapy
  • Hyperlipoproteinemia Type II* / genetics
  • Male
  • Middle Aged
  • Phenotype
  • Proprotein Convertase 9 / genetics
  • Proprotein Convertase 9 / metabolism
  • Prospective Studies
  • Spain / epidemiology
  • Time Factors
  • Treatment Outcome
  • Young Adult

Substances

  • Cholesterol, LDL
  • Anticholesteremic Agents
  • PCSK9 protein, human
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Biomarkers
  • Proprotein Convertase 9
  • Ezetimibe

Associated data

  • ClinicalTrials.gov/NCT02693548