Subgroup analyses showed the benefit of fibrates on the primary composite outcome to be consistent irrespective of age , gender , and diabetes mellitus .
Moderate evidence showed that the fibrate class can be effective in the secondary prevention of composite outcome of non-fatal stroke , non-fatal MI , and vascular death .
However , this beneficial effect relies on the inclusion of clofibrate data , a drug that was discontinued in 2002 due to its unacceptably large adverse effects .
BACKGROUND Fibrates are a class of drugs characterised by mainly lowering high triglyceride , raising high-density lipoprotein ( HDL ) cholesterol , and lowering the small dense fraction of low-density lipoprotein ( LDL ) cholesterol .
Their efficacy for secondary prevention of serious vascular events is unclear , and to date no systematic review focusing on secondary prevention has been undertaken .
OBJECTIVES To assess the efficacy and safety of fibrates for the prevention of serious vascular events in people with previous cardiovascular disease ( CVD ) , including coronary heart disease and stroke .
Comparison of fluvastatin + fenofibrate combination therapy and fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus, and coronary heart disease: a 12-month, randomized, double-blind, controlled trial.
BACKGROUND Diabetes risk is often complicated by a mixed hyperlipoproteinemia not sufficiently controlled by a single antihyperlipidemic drug ; however , there are some concerns about the safety of combined statin and fibrate treatments . OBJECTIVE The aim of this study was to compare the efficacy and safety profile of fluvastatin + fenofibrate combination therapy and those of fluvastatin monotherapy in the treatment of combined hyperlipidemia , type 2 diabetes mellitus ( DM ) , and coronary heart disease ( CHD ) ( ie , high risk for cardiovascular disease [ CVD ] ) . METHODS This 12-month , r and omized , double-blind , controlled trial was conducted at the University of Pavia , Pavia , Italy . Patients aged 18 to 80 years with combined hyperlipidemia , type 2 DM , and CHD were r and omly assigned to receive combination therapy with extended-release fluvastatin 80 mg + micronized fenofibrate 200 mg or monotherapy with extended-release fluvastatin 80 mg . All treatments were given in tablet form , once daily with the evening meal , for 12 months . Lipid variables ( low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , total cholesterol [ TC ] , and triglycerides [ TG ] ) at 6 and 12 months were the primary efficacy variables , and glycemic status ( glycosylated hemoglobin [ HbA(1c ) ] , fasting plasma glucose , and postpr and ial plasma glucose levels ) at 6 and 12 months was the secondary efficacy variable . Tolerability was assessed using physical examination , including vital-sign assessment , body-weight measurement , electrocardiography , adverse events , and laboratory tests . A pharmacoeconomic analysis of both treatment regimens was also carried out using the incremental cost-effectiveness ratio ( ICER ) . RESULTS A total of 48 patients ( 24 men , 24 women ; mean [ SD ] age , 60 [ 5 ] years ) were enrolled . After 6 months , all primary efficacy variables , except for TG level , showed significant improvements from baseline only in the combination-therapy group ( changes : LDL-C , -25 % ; HDL-C , + 12 % ; and TC , -19 % ; all , P < 0.05 vs baseline ) . After 12 months , lipid variables showed significant improvements over baseline in both groups ( all , P < 0.05 ) , except for TG in the monotherapy group . Significant changes in LDL-C , HDL-C , and TG were found in the combination-therapy group ( -35 % , + 34 % , -32 % , respectively ) versus the monotherapy group ( -25 % , + 14 % , -17 % , respectively ; all , P < 0.05 between groups ) . The change from baseline in HbA(1c ) level was significant with combination therapy ( -12 % vs -7 % ; P < 0.05 ) . Both treatments were well tolerated , with no significant differences in the incidences of adverse events between the 2 groups . The ICER showed that each 1 % decrease in LDL-C level achieved with the fenofibrate + fluvastatin combination added a cost of 14.97 Euros/y ( US 12.25 US dollars/y ) , and each 1 % increase in HDL-C level added a cost of 7.48 Euros/y ( 6.12/y US dollars ) , over the cost of monotherapy . CONCLUSIONS In this selected sample of patients with combined hyperlipidemia , type 2 DM , and CHD , the combination of extended-release fluvastatin + micronized fenofibrate was associated with a more improved lipid profile  than fluvastatin monotherapy , and was a well-tolerated and cost-effective therapeutic choice to treat these patients at high risk for CVD
Subgroup analyses showed the benefit of fibrates on the primary composite outcome to be consistent irrespective of age , gender , and diabetes mellitus .
Moderate evidence showed that the fibrate class can be effective in the secondary prevention of composite outcome of non-fatal stroke , non-fatal MI , and vascular death .
However , this beneficial effect relies on the inclusion of clofibrate data , a drug that was discontinued in 2002 due to its unacceptably large adverse effects .
BACKGROUND Fibrates are a class of drugs characterised by mainly lowering high triglyceride , raising high-density lipoprotein ( HDL ) cholesterol , and lowering the small dense fraction of low-density lipoprotein ( LDL ) cholesterol .
Their efficacy for secondary prevention of serious vascular events is unclear , and to date no systematic review focusing on secondary prevention has been undertaken .
OBJECTIVES To assess the efficacy and safety of fibrates for the prevention of serious vascular events in people with previous cardiovascular disease ( CVD ) , including coronary heart disease and stroke .