Comparison of the efficacy and safety of atorvastatin initiated at different starting doses in patients with dyslipidemia

Abstract

Background: The NASDAC study was designed to evaluate the safety and efficacy of atorvastatin at starting doses of 10, 20, 40, and 80 mg.

Methods: After an 8-week placebo washout period, 919 patients who were candidates for lipid-lowering therapy according to the National Cholesterol Education Program's Adult Treatment Panel III guidelines were randomized to 1 of 4 atorvastatin treatment groups: 10 mg (n = 229), 20 mg (n = 228), 40 mg (n = 231), and 80 mg (n = 231).

Results: Atorvastatin reduced low-density lipoprotein cholesterol (LDL-C) levels dose dependently across the 10- to 80-mg-dose range (35.7%-52.2%). Each of the 20-, 40-, and 80-mg doses provided significantly greater decreases in LDL-C than all lower doses (P < .01). All doses also reduced total cholesterol, the LDL-C/high-density lipoprotein cholesterol ratio, apolipoprotein B, and triglycerides from baseline. An increase in high-density lipoprotein cholesterol was observed in all dose groups. Most participants, regardless of their level of coronary heart disease risk, attained their National Cholesterol Education Program's Adult Treatment Panel III LDL-C goal by the end of the study. Patients in all risk groups were more likely to achieve the NCEP LDL-C goal at higher starting doses. Atorvastatin was well tolerated at all dose levels.

Conclusions: Atorvastatin initiated at doses of 10, 20, 40, and 80 mg is effective and safe for the treatment of patients with dyslipidemia. Depending on the percentage reduction needed to achieve an LDL-C goal, patients with or at risk of coronary heart disease may benefit from starting therapy at a higher dose of atorvastatin.