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


BACKGROUND
Combination therapy; Diabetes; Fenofibrate; Metabolic syndrome; Monotherapy; Statin.
Division of Cardiology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan;
Yeh-Peng
YP
Chen
Division of Cardiology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan;
Kuan-Cheng
KC
Chang
Division of Cardiology, Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan;
Wei-Kung
WK
Tseng
Division of Cardiology, Department of Internal Medicine, Cheng-Hsin General Hospital, Taipei, Taiwan;
Wei-Hsian
WH
Yin
Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan;
Jaw-Wen
JW
Chen
Division of Cardiology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan; ; Division of Cardiology, Department of Internal Medicine and Department of Primary Care Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
Yuan-Teh
YT
Lee
Division of Cardiology, Department of Internal Medicine and Department of Primary Care Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
Chau-Chung
CC
Wu