Increased Rosuvastatin Dose versus Concomitant Fenofibrate and Rosuvastatin Therapy to Achieve Lipid Goal in Patients with Diabetes or Atherosclerosis with Metabolic Syndrome.

PUPOSE We aimed to ascertain whether increased rosuvastatin dose is non-inferior to concomitant fenofibrate and rosuvastatin therapy in patients with diabetes or atherosclerosis with metabolic syndrome. METHODS After treatment with rosuvastatin 5 mg/day for 12 weeks, 112 patients were randomly assigned to receive either 10 mg/day rosuvastatin (group A) or 80 mg/day supra-film coated fenofibrate plus 5 mg/day rosuvastatin (group B). The therapy effects were evaluated by measuring the serum lipid profile, liver and muscle enzymes, and renal function after the treatment period. RESULTS After the treatment, the total cholesterol, high-density-lipoprotein cholesterol (HDL-C), non HDL-C, low-density-lipoprotein cholesterol (LDL-C), and triglyceride were comparable between the 2 groups. The change in the non-HDL-C were -7.39 ± 26.58 (-6.62%) and -0.68 ± 24.49 (-1.19%) mg/dl (p = 0.28); and the change in the triglyceride were -36.61 ± 62.51 (-14.00%) and -44.77 ± 77.35 (-23.17%) mg/dl (p = 0.64), respectively. While 41.37% of group A and 38.69% of group B achieved their LDL-C goal (< 100 mg/dl) (p = 0.79), 37.26% of group A and 42.31% of group B achieved their triglyceride goal (< 150 mg/dl) (p = 0.53), respectively. The changes in the serum transaminase and creatinine phosphokinase were similar between the 2 groups. CONCLUSIONS After 5 mg/day of rosuvastatin, the lipid profile in patients with diabetes or atherosclerotic vascular diseases with metabolic syndrome could be improved by increasing rosuvastatin dose, and the resultant decrease of non-HDL and triglyceride were similar to those obtained with combination therapy. Both therapies were safe and feasible. KEY WORDS Combination therapy; Diabetes; Fenofibrate; Metabolic syndrome; Monotherapy; Statin.