12855
document
Effects of ezetimibe , a new cholesterol absorption inhibitor , on plasma lipids in patients with primary hypercholesterolemia . AIMS This randomized , double-blind , placebo-controlled , parallel-group study evaluated the safety and efficacy of ezetimibe 10 mg/day in patients with primary hypercholesterolemia . METHODS AND RESULTS Following dietary stabilization , a 2-12-week washout period , and a 4-week , single-blind , placebo lead-in period , 827 patients with baseline low-density lipoprotein cholesterol ( LDL-C ) > or =3.36 mmol/l ( 130 mg/dl ) to < or =6.47 mmol/l ( 250 mg/dl ) and triglycerides < or =3.95 mmol/l ( 350 mg/dl ) were randomized 3:1 to receive ezetimibe 10 mg or placebo orally once daily in the morning for 12 weeks . The primary efficacy endpoint was percentage reduction in direct plasma LDL-C. Ezetimibe reduced direct LDL-C by a mean of 17.7 % from baseline to endpoint , compared with an increase of 0.8 % with placebo ( P < 0.01 ) . Response to ezetimibe was generally consistent across all subgroups analyzed . Ezetimibe also significantly improved levels of plasma total cholesterol , apolipoprotein B , high-density lipoprotein ( 2 ) -cholesterol and lipoprotein ( a ) , and elicited a trend toward lower triglyceride levels . Ezetimibe did not alter the serum concentrations of lipid-soluble vitamins or significantly affect baseline or stimulated cortisol production . Ezetimibe was well tolerated , with a safety profile similar to that of placebo . CONCLUSIONS Ezetimibe , which significantly reduces LDL-C and favorably affects other lipid variables , may provide a well tolerated and effective new option for lipid management in the future .
12856
Intervention_Pharmacological
ezetimibe
12857
Intervention_Control
placebo-controlled
12858
Intervention_Pharmacological
ezetimibe
12859
Intervention_Control
placebo
12860
Intervention_Pharmacological
ezetimibe 10 mg or placebo
12861
Intervention_Pharmacological
ezetimibe
12862
Intervention_Pharmacological
Ezetimibe
12863
Intervention_Pharmacological
Ezetimibe
12864
Intervention_Pharmacological
Ezetimibe
12865
Intervention_Pharmacological
Ezetimibe
12866
Outcome_Physical
plasma lipids
12867
Outcome_Physical
percentage reduction in direct plasma LDL-C.
12868
Outcome_Physical
direct LDL-C
12869
Outcome_Physical
levels of plasma total cholesterol
12870
Outcome_Physical
apolipoprotein B
12871
Outcome_Physical
high-density lipoprotein ( 2 ) -cholesterol and lipoprotein ( a )
12872
Outcome_Physical
elicited a trend toward lower triglyceride levels
12873
Outcome_Physical
the serum concentrations of lipid-soluble vitamins or significantly affect baseline or stimulated cortisol production
12874
Outcome_Other
well tolerated
12875
Outcome_Other
safety profile
12876
Outcome_Physical
LDL-C
12877
Outcome_Physical
lipid variables
12878
Outcome_Mental
well tolerated
12879
Participant_Condition
patients with primary hypercholesterolemia .
12880
Participant_Condition
patients with primary hypercholesterolemia .