Effects of simvastatin (40 and 80 mg/day) in patients with mixed hyperlipidemia

Mixed hyperlipidemia is characterized by both elevated total cholesterol an d triglycerides. It is estimated to account for 10% to 20% of patients with dyslipidemia, This study assessed the lipid-altering efficacy and tolerabi lity of simvastatin 40 and 80 mg/day as monotherapy. One hundred thirty pat ients (62 women [48%], 24 [16%] with type 2 diabetes mellitus, mean age 53 years) with mixed hyperlipidemia (baseline low-density lipoprotein [LDL] ch olesterol 156 mg/dl [mean], and triglycerides 391 mg/dl [median) were rando mized in a multicenter, double-masked, placebo-controlled, 3-period, 22-wee k, balanced crossover study, and received placebo, and simvastatin 40 and 8 0 mg/day each for 6 weeks. Compared with placebo, simvastatin produced sign ificant (p <0.01) and dose-dependent changes in all lipid and lipoprotein p arameters (LDL cholesterol 2.1%, -28.9%, and -35.5%; triglycerides -3.5%, - 27.8%, and -33.0%; high-density lipoprotein cholesterol 3.3%, 13.1%, and 15 .7%; apolipoprotein B 3.8%, -23.1%, and -30.6%; and apolipoprotein A-I 4.0% , 8.2%, and 10.5% with placebo, and simvastatin 40 and 80 mg/day, respectiv ely). The changes were consistent in patients with diabetes mellitus. One p atient taking simvastatin 80 mg/day had an asymptomatic and reversible incr ease in hepatic transaminases 3 times above the upper limit of normal. Simv astatin 40 and 80 mg/day is effective in patients with mixed hyperlipidemia across the entire lipid and lipoprotein profile. The reductions in LDL cho lesterol and triglycerides are large, significant, and dose dependent. The increase in high-density lipoprotein cholesterol was greater than that obse rved in patients with hypercholesterolemia, and appears dose dependent. (C) 2000 by Excerpta Medica, Inc.