Comparative efficacy and safety of fenofibrate/pravastatin plus ezetimibe triple therapy and simvastatin/ezetimibe dual therapy in type 2 diabetic patients with mixed hyperlipidaemia and cardiovascular disease.
BACKGROUND
This study was designed to compare the efficacy and safety of a fenofibrate/pravastatin 160/40 mg fixed-dose combination plus ezetimibe 10 mg triple therapy and simvastatin 20 mg plus ezetimibe 10 mg dual therapy in patients with type 2 diabetes, mixed hyperlipidaemia and cardiovascular disease.


METHODS
After a 6-week run-in period on simvastatin 20 mg, 273 patients with non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dl or low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dl were randomised to receive 12-week treatment with triple therapy or dual therapy, followed by a 12-week safety period during which all patients received the triple therapy.


RESULTS
At week 12, similar significant decreases in non-HDL-C were observed with both treatments. The triple therapy has induced a greater decrease in triglycerides (between-treatment difference: -14.6%, p = 0.007) and the dual therapy a greater decrease in LDL-C (between-treatment difference: +5.3%, p = 0.05). Both treatments were generally well tolerated.


CONCLUSIONS
The fenofibrate/pravastatin plus ezetimibe therapy improves the global atherogenic lipid profile in type 2 diabetic patients with mixed hyperlipidaemia.
Point Medical, Dijon, France. michelfarnier@nerim.net
Michel
M
Farnier
Kjetil
K
Retterstøl
Armin
A
Steinmetz
Albert
A
Császár
D000368:Aged; D001384:Azetidines / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000150:complications*; D008076:Cholesterol, HDL / Q000187:drug effects; D008078:Cholesterol, LDL / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000150:complications / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000627:therapeutic use*; D019821:Simvastatin / Q000627:therapeutic use*; D016896:Treatment Outcome
D001384:Azetidines; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004338:Drug Combinations; D000960:Hypolipidemic Agents; D019821:Simvastatin; D000069438:Ezetimibe; D017035:Pravastatin; D011345:Fenofibrate