Efficacy of a combination of cholesterol absorption and synthesis inhibitors in the correction of hyperlipidemia and dietary fat intolerance in patients with coronary heart disease (ESTHETICS trial)

Abstract

Objective: to study the lipid-modifying effects of the selective intestinal cholesterol absorption inhibitor ezetimibe as monotherapy and in combination with simvastatin, an inhibitor of hydroxy methyl glutaryl coenzyme A (HMG-CoA) reductase, a key enzyme in cholesterol synthesis, which is given on an empty stomach and after single dietary fat intake (FI) that modulates postprandial hyperlipidemia (HL) in coronary heart disease (CHD) patients with baseline HL. Subjects and method. The trial covered 30 patients aged 43–75 years with CHD and baseline HL of Types IIa and IIb (Fredrickson classification) who were, after 4-week therapy, randomized to 2 groups: 1) 15 patients took ezetimibe 10 mg/day and 2) 15 received simvastatin 20 mg/day (the total duration of monotherapy was 12 weeks), then its half dose (from 20 to 10 mg/day) added by ezetimibe 10 mg/day (the duration of the combination therapy was 12 weeks). All the patients underwent standard FI test before and after a 12-week monotherapy period and 24 weeks (i.e. after 12-weel combination therapy). A standard FI test was carried out by the modified procedure described by J. Patsch (1983); the cutoffs for blood sampling for analysis were on an empty stomach (before FI) and 3 and 6 hours after FI. Results. The patients with CHD treated with ezetimibe 10 mg showed a significant reduction in the fasting levels of total cholesterol (TC) by 20% (p