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A 3-year study of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia.

Author information

Affiliations

  • 1. Department of Endocrinology, Morbid Obesity and Preventive Medicine, Lipid Clinic, Oslo University Hospital, Oslo, Norway.
      Authors
    • Langslet G 1
    (1 author)
  • 2. Pfizer Inc, New York, NY, USA.
      Authors
    • Breazna A 2
    (1 author)
  • 3. Metabolic Unit, Choremio Goudi Research Institute, 1st Department of Pediatrics, Medical School University of Athens, Aghia Sofia Children's Hospital, Athens, Greece.
      Authors
    • Drogari E 3
    (1 author)

Journal of Clinical Lipidology, 07 Jun 2016, 10(5):1153-1162.e3
https://doi.org/10.1016/j.jacl.2016.05.010 PMID: 27678432 

Abstract 

Background

The efficacy and safety of atorvastatin in children/adolescents aged 10-17 years with heterozygous familial hypercholesterolemia (HeFH) have been demonstrated in trials of up to 1 year in duration. However, the efficacy/safety of >1 year use of atorvastatin in children/adolescents with HeFH, including children from 6 years of age, has not been assessed.

Objective

To characterize the efficacy and safety of atorvastatin over 3 years and to assess the impact on growth and development in children aged 6-15 years with HeFH.

Methods

A total of 272 subjects aged 6-15 years with HeFH and low-density lipoprotein cholesterol (LDL-C) ≥4.0 mmol/L (154 mg/dL) were enrolled in a 3-year study (NCT00827606). Subjects were initiated on atorvastatin (5 mg or 10 mg) with doses increased to up to 80 mg based on LDL-C levels.

Results

Mean percentage reductions from baseline in LDL-C at 36 months/early termination were 43.8% for subjects at Tanner stage (TS) 1 and 39.9% for TS ≥2. There was no evidence of variations in the lipid-lowering efficacy of atorvastatin between the TS groups analyzed (1 vs ≥2) or in subjects aged <10 vs ≥10 years, and the treatment had no adverse effect on growth or maturation. Atorvastatin had a favorable safety and tolerability profile, and only 6 (2.2%) subjects discontinued because of adverse events.

Conclusions

Atorvastatin over 3 years was efficacious, had no impact on growth/maturation, and was well tolerated in children and adolescents with HeFH aged 6-15 years.

Full text links 

Read article at publisher's site: https://doi.org/10.1016/j.jacl.2016.05.010

Read article for free, from open access legal sources, via Unpaywall: http://www.lipidjournal.com/article/S1933287416302197/pdfUnpaywall

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