[Effects of simvastatin on plasma levels of lipids, lipoproteins and apolipoproteins in primary hypercholesterolemia]. / Effetti del simvastatin sui livelli plasmatici dei lipidi, delle lipoproteine e delle apolipoproteine nell'ipercolesterolemia primitiva.

To evaluate the effectiveness, tolerance and safety of simvastatin (MK 733), a new HMG-CoA reductase inhibitor, a 28-week, single blind study with placebo was carried out on 10 patients suffering from primary hypercholesterolaemia. All patients followed the AHA Phase 1 or Phase 2 diet and underwent active treatment for 24 weeks with increasing doses of simvastatin from 10 to 40 mg in a single evening administration. A reduction in plasma levels of total cholesterol (-29%, p less than 0.001 and -41%, p less than 0.001), LDL cholesterol (-35%, p less than 0.001 and -49%, p less than 0.001), VLDL cholesterol (-9%, ns and -38%, ns), Apo-B (-27%, p less than 0.005 and -37%, p less than 0.001), Apo-A2 (-3%, ns and -3%, ns), and triglycerides (+2%, ns and -10%, ns), was obtained in the VIth and XXIVth week. There was also an increase in HDL cholesterol (+4%, ns and +17%, p less than 0.05), HDL2 subfractions (+9%, p less than 0.05 and +36%, p less than 0.05), HDL3 (+3%, ns and +11%, ns) and Apo-A1 (+7%, ns and +4%, ns). In all patients, simvastatin was generally tolerated and there were no clinical, laboratory or ophthalmological side-effects related to the drug. If long-term studies confirm its safety, simvastatin will offer excellent prospects for the prevention of ischaemic cardiopathy.