Atorvastatin 10 mg plus ezetimibe 10mg compared with atorvastatin 20 mg: impact on the lipid profile in Japanese patients with abnormal glucose tolerance and coronary artery disease

• Published in: Journal of cardiology Vol. 59; no. 1; pp. 50 - 56
• Main Authors: Uemura, Yusuke, Watarai, Masato, Ishii, Hideki, Koyasu, Masayoshi, Takemoto, Kenji, Yoshikawa, Daiji, Shibata, Rei, Matsubara, Tatsuaki, Murohara, Toyoaki
• Format: Journal Article
• Language: English
• Published: Netherlands 01.01.2012
• Subjects: Aged; Anticholesteremic Agents - administration & dosage; Apolipoprotein A-I - blood; Apolipoproteins B - blood; Atorvastatin Calcium; Azetidines - administration & dosage; Cholesterol - blood; Cholesterol, LDL - blood; Coronary Disease - blood; Coronary Disease - drug therapy; Coronary Disease - prevention & control; Cross-Over Studies; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Drug Therapy, Combination; Ezetimibe; Female; Glucose Intolerance - blood; Glucose Intolerance - complications; Glucose Intolerance - drug therapy; Heptanoic Acids - administration & dosage; Humans; Lipoproteins, LDL - blood; Male; Malondialdehyde - analogs & derivatives; Malondialdehyde - blood; Oxidation-Reduction; Prospective Studies; Pyrroles - administration & dosage
• ISSN: 1876-4738
• DOI: 10.1016/j.jjcc.2011.09.001

Oxidized low-density lipoprotein (LDL) cholesterol is a sensitive lipid marker for predicting atherosclerosis. Ezetimibe and statins are reported to decrease both LDL cholesterol and oxidized LDL cholesterol. This prospective randomized open-label crossover study compared combination therapy with atorvastatin plus ezetimibe versus high-dose atorvastatin monotherapy. Changes in serum lipids, including malondialdehyde-modified LDL (MDA-LDL) as a representative form of oxidized LDL cholesterol, and glucose metabolism were assessed. The subjects were 39 Japanese patients with coronary artery disease and type 2 diabetes or impaired glucose tolerance who were taking 10 mg/day of atorvastatin (30 men and 9 women with a mean age of 67.8 years). They were randomized to a group that first received add-on ezetimibe (10 mg/day) or a group that first received atorvastatin monotherapy at a higher dose of 20 mg/day. Both treatments were given for 12 weeks each in a crossover fashion. Add-on ezetimibe significantly decreased MDA-LDL (109.0 ± 31.9 mg/dl to 87.7 ± 29.4 mg/dl, p=0.0009), while up-titration of atorvastatin did not. The decrease with add-on ezetimibe was significantly greater than with up-titration of atorvastatin (p=0.0006). Total cholesterol and LDL cholesterol were significantly decreased by both treatments, but the percent reduction with add-on ezetimibe was significantly greater (p<0.05). High-density lipoprotein cholesterol was significantly increased by both treatments and there was no significant difference between them. The apolipoprotein B/apolipoprotein A-I ratio and remnant-like particle cholesterol were only significantly decreased by add-on ezetimibe. Both treatments caused similar elevation of hemoglobin A(1c). In Japanese patients with type 2 diabetes or impaired glucose tolerance and coronary artery disease, adding ezetimibe (10 mg/day) to atorvastatin (10 mg/day) significantly improved the lipid profile compared with atorvastatin monotherapy at 20 mg/day.