Conclusions Ezetimibe monotherapy ( 10 mg/day ) showed a small ( 7.06 % ) but statistically significant reduction in the plasma levels of Lp(a ) in patients with primary hypercholesterolemia .
According to current literature , this magnitude of reduction seems to have no clinical relevance .
Background and Aims Ezetimibe reduces plasma low-density lipoprotein cholesterol ( LDL-C ) levels by up to 20 % .
However , its effect on plasma lipoprotein(a ) [ Lp(a ) ] concentrations in patients with primary hypercholesterolemia has not been defined .
Objective Therefore , we performed a systematic review and meta- analysis to assess this effect based on the available r and omized controlled trials ( RCTs ) .
Effectiveness and tolerability of ezetimibe in patients with primary hypercholesterolemia: pooled analysis of two phase II studies.
BACKGROUND Ezetimibe ( SCH 58235 ) is a novel cholesterol absorption inhibitor that selectively and potently blocks intestinal absorption of dietary and biliary cholesterol . OBJECTIVE Data from 2 multicenter , placebo-controlled , double-blind , r and omized , parallel-group , 12-week studies of ezetimibe were pooled to evaluate the drug 's effect on lipid parameters in patients with primary hypercholesterolemia . METHODS After dietary stabilization ( National Cholesterol Education Program Step I diet or a stricter diet ) , washout of lipid-altering drugs , and a 6-week placebo lead-in period , patients with baseline plasma low-density lipoprotein cholesterol ( LDL-C ) levels > or = 130 and < or = 250 mg/dL and plasma triglyceride ( TG ) levels < or = 300 mg/dL were r and omized to receive either ezetimibe 0.25 , 1 , 5 , or 10 mg , or placebo administered once daily before the morning meal in study A ( dose-response study ) or ezetimibe 5 or 10 mg or placebo administered once daily before the morning meal or at bedtime in study B ( dose-regimen study ) . RESULTS A total of 432 patients were included in this pooled analysis , 243 in study A and 189 in study B. The 5- and 10-mg doses of ezetimibe significantly reduced LDL-C levels by 15.7 % and 18.5 % , respectively ( P < 0.01 vs placebo ) and significantly increased high-density lipoprotein cholesterol ( hDL-C ) levels by 2.9 % and 3.5 % , respectively ( P < 0.05 vs placebo ) . A reduction in plasma TG levels was observed ( P = NS ) . With the 10-mg dose of ezetimibe , 67.8 % of patients achieved > or = 15 % reduction in plasma LDL-C levels , and 22.0 % achieved > or = 25 % reduction . With the 5-mg dose , 54.0 % of patients achieved > or = 15 % reduction in plasma LDL-C levels , and 15.3 % achieved > or = 25 % reduction . The decrease in plasma LDL-C levels was significantly greater with ezetimibe 10 mg compared with ezetimibe 5 mg ( P < 0.05 ) . Ezetimibe was well tolerated , with an adverse event profile similar to that of placebo . CONCLUSIONS In these two 12-week studies , ezetimibe significantly decreased plasma LDL-C levels and increased plasma HDL-C levels , with a tolerability profile similar to that of placebo
Conclusions Ezetimibe monotherapy ( 10 mg/day ) showed a small ( 7.06 % ) but statistically significant reduction in the plasma levels of Lp(a ) in patients with primary hypercholesterolemia .
According to current literature , this magnitude of reduction seems to have no clinical relevance .
Background and Aims Ezetimibe reduces plasma low-density lipoprotein cholesterol ( LDL-C ) levels by up to 20 % .
However , its effect on plasma lipoprotein(a ) [ Lp(a ) ] concentrations in patients with primary hypercholesterolemia has not been defined .
Objective Therefore , we performed a systematic review and meta- analysis to assess this effect based on the available r and omized controlled trials ( RCTs ) .