Efficacy of simvastatin therapy in attainment of LDL-C and TG goal levels in patients with type 2 diabetic dyslipidemia

BACKGROUND: Low-density lipoprotein cholesterol (LDL-C) has been identified as the primary target of cholesterol-lowering therapy, with the LDL-C goal set at <= 100 mg/dL for patients at high risk, such as those with diabetes. OBJECTIVE: To evaluate the efficacy of simvastatin (S) in achieving LDL-C levels <70 mg/dL in patients with type 2 diabetes mellitus (DM). METHODS: This was a post-hoc analysis of a multicenter, randomized, double-blind, three-way crossover, placebo (PL)-controlled study that evaluated S80 mg or S40 mg versus PL for increasing high-density lipoprotein cholesterol (HDL-C). Patients with type 2 DM (n = 151), LDL-C >100 mg/dL, HDL-C <40 mg/dL, and triglycerides (TG) > 150 and <700 mg/dL were randomized to daily S80 mg, S40 mg, or PL for three 6-week periods. The percentage of patients reaching LDL-C <70 mg/dL and the percentage reaching TG <150 mg/dL after 6 weeks was assessed. RESULTS: After 6 weeks, 59% (82 of 140) of patients in the S80 mg group achieved LDL-C <70 mg/dL versus 43% (60 of 139) receiving S40 m, and 0% (0 fo 140) in the PL group (P < 0.001 for S80 mg and S40 mg vs PL, and S80 mg vs S40 mg). In patients with coronary heart disease (CHD) (n = 32), 63% (20 of 32) receiving S80 mg reached LDL-C <70 mg/dL, versus 50% (15 of 30) in the S40 mg and 0% (0 of 32) in the PL group (P <0.001 for S80 mg and S40 mg vs PL, and P = 0.063 for S80 mg vs S40 mg For TG levels, 27% (35 of 132) of the S80 mg patients and 23% (30 of 130) of the S40 mg patients reached a goal of TG < 150 mg/dL. The dual goal of LDL-C level <70 mg/dL and TG level < 150 mg/dL was attained by 14.7% of patients in the S80 mg, 7.8% in the S40 mg, and 0% in the PL group. CONCLUSION: S40 mg or S80 mg daily allowed 43%,to 59% of patients with type 2 DM at risk of CHD to reach the goal of lowering LDL-C levels to the National Cholesterol Education Program Adult Treatment Panel III optional target level of <70 mg/dL. Reaching TG goals may require additional therapeutic considerations. (C) 2008 National Lipid Association. All rights reserved.