J Cardiovasc Pharrnacol Therapeut I(2): I 17-122, I996 Atorvastatin, a New HMG-CoA Reductase Inhibitor as Monotherapy and Combined With Colestipol

Background: Atorvastatin, a new HhlG-CoA reductase inhibitor in clinical development has demonstrated an acceptable safety profile and marked cholesterol and triglyceride reduction at doses ranging from 10-80 mgday. Since bile acid sequestering resins are often used in combination with HMGRIs to enhance cholesterol reduction, this trial was conducted to explore the use of atorvastatin alone and combined with colestipol in patients with primary hyperlipidemia. Metlids and Results: One hundred six patients with low-density lipoprotein (LDL) choles-terol> 4.1 mM/L (160 mddL) and plasma triglycerides < 3.9 mh4L (350 mg/dL) were ran-domized to treatment consisting of 20 glday colestipol, 10 mg/day atorvastatin, or 10 mg/day atorvastatin plus 20 dday colestipol for 12 weeks. Percent change from baseline in lipid vxi-ables was measured. The atorvastatin group showed a significant reduction in LDL choles-terol of 35 % after 12 weeks. Combination therapy provided an additional 10 % reduction in LDL cholesterol over that observed for atorvastatin alone. Twenty-one percent of all patients in the atorvastatin monotherapy group experienced associated adverse events compared with 60 % in the combination therapy group. Ninety percent of atorvastatin monotherapy patient