title: Long-term experience (6 years) with simvastatin in patients with heterozygous familial hypercholesterolaemia.
abstract: OBJECTIVE
  To study the long-term efficacy and safety of the cholesterol synthesis inhibitor, simvastatin, in the treatment of familial hypercholesterolaemia.
  
  
  METHODS
  This is an open long-term follow-up of patients treated for 5 years or more in the Nijmegen University lipid clinic. Forty-four patients with heterozygous familial hypercholesterolaemia (mean baseline serum cholesterol level 11.5 mmol/l) were treated with simvastatin alone (monotherapy group) in doses ranging from 20 to 80 mg/day, or in combination with other lipid-lowering agents (combination-therapy group).
  
  
  RESULTS
  Over the intervention period of 6 years the mean overall reduction of the serum cholesterol level was 37.8% for the total group, 37.7% for the monotherapy group and 42.6% for the combination-therapy group. The reduction of the low-density lipoprotein (LDL)-cholesterol in the three groups was 45.0, 44.6 and 50.3%, respectively. The serum triglyceride concentration was reduced by 14.0, 20.5 and 12.5%, respectively. The increase in the high-density lipoprotein (HDL)-cholesterol level was 14.4, 16.2 and 14.0%, respectively. One patient died from a myocardial infarction and 2 patients had a non-fatal cardiac event. Two patients stopped taking medication due to side-effects (dizziness and insomnia). Biochemical adverse effects were confined to elevations of the alanine aminotransferase level and the creatine phosphokinase level and did not lead to discontinuation of therapy.
  
  
  CONCLUSIONS
  Simvastatin proves to be a safe and effective lipid-lowering drug during long-term treatment.
authors.affiliation: Department of Medicine, St. Radboud University Hospital, Nijmegen, Netherlands.
authors.forename: R E
authors.initials: RE
authors.lastname: Knops
authors.forename: A A
authors.initials: AA
authors.lastname: Kroon
authors.forename: M J
authors.initials: MJ
authors.lastname: Mol
authors.forename: P M
authors.initials: PM
authors.lastname: Stuyt
authors.forename: A F
authors.initials: AF
authors.lastname: Stalenhoef
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006579:Heterozygote; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy* / Q000235:genetics; D008148:Lovastatin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019821:Simvastatin
chemical_list: D000924:Anticholesteremic Agents; D008148:Lovastatin; D019821:Simvastatin