Monotherapy with either fibrates or statins suggested a significantly greater effect of fibrates in lowering plasma Fib concentrations .
According to these findings , mechanisms associated with fibrinogen metabolism might be responsible for the distinct effects of statins and fibrates in reducing cardiovascular endpoints
BACKGROUND Several studies suggest differences between fibrates and statins in lowering plasma fibrinogen ( Fib ) concentrations , but the evidence is not definitive .
Therefore , the aim of this meta- analysis of head-to-head r and omized trials was to compare the efficacy of statins and fibrates on plasma Fib concentrations .
Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study.
BACKGROUND Coadministration of statin and fenofibrate monotherapies is frequently used to treat patients with dyslipidemia ; however , a fixed-dose combination ( FDC ) tablet is not currently marketed . OBJECTIVE This study evaluates a new FDC tablet of atorvastatin 40 mg and fenofibrate 100 mg . METHODS This was a 12-week , multicenter , double-blind , r and omized , parallel-group Phase IIb study . Adults with dyslipidemia ( non-HDL-C > 130 mg/dL and triglycerides [ TG ] > or = 150 but < or = 500 mg/dL ) were r and omly assigned in a 1:1:1 ratio to receive the FDC , atorvastatin 40 mg , or fenofibrate 145 mg for 12 weeks . Study medication was taken once daily in the evening , without regard to meals . Patients attended follow-up visits after 4 , 8 , and 12 weeks of the double-blind treatment . The primary efficacy end points were the mean percentage changes from baseline to the final visit ( week 12 ) in non-HDL-C , HDL-C , and TG . Secondary variables were LDL-C , VLDL-C particle concentration , total cholesterol , apolipoprotein B , lipoprotein ( a ) , high-sensitivity C-reactive protein , fibrinogen , homocysteine , creatinine , myeloperoxidase , and lipoprotein-associated phospholipase A2 . Tolerability was assessed by adverse events , laboratory parameters , vital signs , physical examinations , and ECGs . RESULTS Patients ( n = 220 ) were aged 26 to 87 years ; 115 ( 52.3 % ) were men and 105 ( 47.7 % ) were women ; 189 ( 85.9 % ) were white , 17 ( 7.7 % ) were black , and 15 ( 6.8 % ) were Hispanic or Latino ; and mean ( SD ) weight was 200.5 ( 40.85 ) lb ( range , 103.5 - 367.4 lb ) . Previous treatments were statins ( 25.9 % [ 57/220 ] ) , fibrates ( 1.8 % [ 4/220 ] ) , and dietary supplements ( 25.5 % [ 56/220 ] ) ; 57.7 % ( 127/220 ) of patients were treatment naive . Use of the FDC was associated with an improvement in non-HDL-C ( -44.8 % ) that was significantly greater than with fenofibrate monotherapy ( -16.1 % ; P < 0.001 ) but was not significantly different from that with atorvastatin monotherapy ( -40.2 % ; P = NS ) . HDL-C increased significantly more in the FDC group ( 19.7 % ) than with atorvastatin ( 6.5 % ; P < 0.001 ) but was not significantly different from fenofibrate ( 18.2 % ; P = NS ) . TG lowering in the FDC group ( -49.1 % ) was significantly greater than with both atorvastatin ( -28.9 % ; P < 0.001 ) and fenofibrate ( -27.8 % ; P = 0.001 ) . LDL-C lowering in the FDC group ( -42.3 % ) was significantly greater than with fenofibrate ( -13.9 % ; P < 0.001 ) but not significantly different from atorvastatin ( -43.1 % ; P = NS ) . The FDC had either comparable or significantly greater improvements in other lipid variables and multiple secondary variables . The FDC was generally well tolerated ; the tolerability profile was consistent with those of atorvastatin and fenofibrate monotherapies . Treatment-emergent adverse events ( ie , those occurring after the first dose of study medication ) were recorded in 43 of 73 patients ( 58.9 % ) for the FDC , 49 of 74 ( 66.2 % ) for atorvastatin , and 48 of 73 ( 65.8 % ) for fenofibrate . CONCLUSIONS In this 12-week study , patients with dyslipidemia treated with the 40/100-mg atorvastatin/ fenofibrate FDC had a significantly greater reduction in TG than those treated with atorvastatin 40 mg or higher-dose fenofibrate 145 mg . Treatment with the FDC was also associated with a significantly greater reduction in non-HDL-C compared with fenofibrate alone and a greater increase in HDL-C compared with atorvastatin alone . All treatments were generally well tolerated
Monotherapy with either fibrates or statins suggested a significantly greater effect of fibrates in lowering plasma Fib concentrations .
According to these findings , mechanisms associated with fibrinogen metabolism might be responsible for the distinct effects of statins and fibrates in reducing cardiovascular endpoints
BACKGROUND Several studies suggest differences between fibrates and statins in lowering plasma fibrinogen ( Fib ) concentrations , but the evidence is not definitive .
Therefore , the aim of this meta- analysis of head-to-head r and omized trials was to compare the efficacy of statins and fibrates on plasma Fib concentrations .