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 .
Rationale and design of a secondary prevention trial of increasing serum high-density lipoprotein cholesterol and reducing triglycerides in patients with clinically manifest atherosclerotic heart disease (the Bezafibrate Infarction Prevention Trial).
Controlled clinical trials have demonstrated the efficacy of reducing the blood levels of low-density lipoprotein cholesterol in reducing the incidence of coronary artery disease in hypercholesterolemic middle-aged men . However , a similar reversibility of the risk of coronary artery disease has not been demonstrated for high-density lipoprotein cholesterol elevation and triglyceride reduction . Therefore , the effect of administering 400 mg of bezafibrate retard daily versus placebo ( double blind ) to patients with myocardial infa rct ion preceding r and omization by 6 months to 5 years , or a clinical ly manifest anginal syndrome documented by objective evidence of dynamic myocardial ischemia , or both , is being investigated . Three thous and subjects ( aged 45 to 74 years ) are being enrolled from 19 cardiac departments in Israel , with total serum cholesterol between 180 and 250 mg/dl , high-density lipoprotein cholesterol < or = 45 mg/dl and triglycerides < or = 300 mg/dl . In addition , low-density lipoprotein cholesterol concentrations are required to be < or = 180 mg/dl ( < or = 160 mg/dl for patients aged < 50 years ) . Patients needing lipid-modifying therapy , exhibiting > or = 1 prespecified exclusion criterion or not giving informed consent , or a combination , are not r and omized . The primary end points for evaluating efficacy are the incidence of fatal and nonfatal myocardial infa rct ion , and sudden death . The hypothesized effect of bezafibrate administration under the aforementioned protocol is to reduce an estimated cumulative end point event incidence of > or = 15 % by 20 to 25 % over an average follow-up period of 6.25 years , through early 1998 , when the last patient recruited will have completed 5 years . ( ABSTRACT TRUNCATED AT 250 WORDS
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 .