NR AGPR

AU Knops,R.E.; Kroon,A.A.; Mol,M.J.; Stuyt,P.M.; Stalenhoef,A.F.

TI Long-term experience (6 years) with simvastatin in patients with heterozygous familial hypercholesterolaemia

QU Netherlands Journal of Medicine 1995 Apr; 46(4): 171-8

PT clinical trial; controlled clinical trial; journal article

AB 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.

MH Adult; Anticholesteremic Agents/*therapeutic use; Female; Follow-Up Studies; Heterozygote; Human; Hypercholesterolemia, Familial/blood/*drug therapy/genetics; Lovastatin/*analogs & derivatives/therapeutic use; Male; Middle Age; Retrospective Studies; Simvastatin

AD Department of Medicine, St. Radboud University Hospital, Nijmegen, Netherlands.

SP englisch

PO Niederlande

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