LONG-TERM EXPERIENCE (6 YEARS) WITH SIMVASTATIN IN PATIENTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA

Objective: To study the long-term efficacy and safety of the cholester ol synthesis inhibitor, simvastatin, in the treatment of familial hype rcholesterolaemia. Methods: This is and open long-term follow-up of pa tients treated for 5 years of more in the Nijmegen University lipid cl inic. Forty-four patients with heterozygous familial hypercholesterola emia (mean baseline serum cholesterol level 11.5 mmol/1) were treated with simvastatin alone (monotherapy group) in doses ranging from 20 to 80 mg/day, or in combination with other lipid-lowering agents (combin ation therapy group). Results: Over the intervention period of 6 years the mean overall reduction of the serum cholesterol level was 37.8% f or the total group, 37.7% for the monotherapy group and 42.6% for the combination therapy group. The reduction of the low density lipoprotei n (LDL)-cholesterol in the three groups was 45.0, 44.6 and 50.3, respe ctively. 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 p atient died from a myocardial infarction and 2 patients had a non-fata l cardiac event. Two patients stopped taking medication due to side-ef fects (dizziness and insomnia). Biochemical adverse effects were confi ned to elevations of the alanine aminotransferase level and the creati ne phosphokinase level and did not lead to discontinuation of therapy. Conclusions: Simvastatin proves to be a safe and effective lipid lowe ring drug during long-term treatment.