Efficacy and Safety of a New HMG-CoA Reductase Inhibitor, Atorvastatin, in Patients With Hypertriglyceridemia

摘要: Objective. —To assess the lipid-lowering effect of atorvastatin (a new 3-hydroxy-3-methylglutaryl coenzyme A [HMG-CoA] reductase inhibitor) on levels serum triglycerides and other lipoprotein fractions in patients with primary hypertriglyceridemia, determine if causes a redistribution various fractions, its safety by reporting adverse events clinical laboratory measurements. Design. —Randomized double-blind, placebo-controlled, parallel-group, multicenter trial. Setting. —Community- university-based research centers. Patients. —A total 56 (aged 26 to 74 years) mean baseline triglyceride level 6.80 mmol/L (603.3 mg/dL) low-density cholesterol (LDL-C) 3.07 (118.7 mg/dL). Interventions. —Cholesterol-lowering diet (National Institutes Health National Cholesterol Education Program Step I Diet) either 5 mg, 20 or 80 mg atorvastatin, placebo. Main Outcome Measures. —Percent change from for three dose compared Results. —Mean reductions between placebo after 4 weeks treatment were —26.5%, —32.4%, —45.8%, —8.9%, respectively. Mean LDL-C —16.7%, —33.2%, —41.4%, —1.4%, respectively, very (VLDL-C) —34.3%, —45.9%, —57.7%, —5.5%, Similar changes apolipoprotein B (apo B) (—16.9%, —32.8%, —41.7%, + 1.0%), apo LDL (—14.8%, —29.8%, —42.0%,and —3.1%),and VLDL (—23.8%, —35.8%, —34.4%, +11.7%) observed. In addition, comparable (—22.5%, —30.7%, —39.9%, +3.9%) (—28.1%, —34.0%, —47.3%, —10.8%) seen. Conclusions. —In groups, decreased dose-dependent manner; 20-mg 80-mg groups statistically significant (P (JAMA. 1996;275:128-133)