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Use of fenofibrate on cardiovascular outcomes in statin users with metabolic syndrome: propensity matched cohort study. To investigate whether fenofibrate as add-on to statin treatment reduce persistent cardiovascular risk in adults with metabolic syndrome in a real world setting.Propensity matched cohort study.Population based cohort in Korea.29 771 adults with metabolic syndrome (≥40 years) receiving statin treatment. 2156 participants receiving combined treatment (statin plus fenofibrate (...) to be associated with the low risk of composite cardiovascular events with combined treatment.In this propensity weighted cohort study of adults with metabolic syndrome, the risk of major cardiovascular events was significantly lower with fenofibrate as add-on to statin treatment than with statin treatment alone.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Associations of Fenofibrate Therapy WithÂ Incidence and Progression of CKD inÂ Patients With Type 2 Diabetes. Abnormalities in lipid metabolism may contribute to the development and progression of chronic kidney disease (CKD) in patients with type 2 diabetes. Fenofibrate induces early and reversible reduction in estimated glomerular filtration rate (eGFR), but it may have protective effects on microvascular complications of diabetes. We hypothesized that randomization to fenofibrate versus (...) placebo would be associated with beneficial long-term effects on kidney outcomes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial participants.We conducted a post hoc analysis in the ACCORD Lipid Trial to examine the association of randomization to fenofibrate versus placebo with change in eGFR and with time-to-development of microalbuminuria, macroalbuminuria, CKD, and kidney failure.We analyzed 2636 participants in the fenofibrate arm and 2632 in the placebo arm. During
Fenofibrate Top results for fenofibrate - Trip Database or use your Google+ account Find evidence fast ALL of these words: Title only Anywhere in the document ANY of these words: Title only Anywhere in the document This EXACT phrase: Title only Anywhere in the document EXCLUDING words: Title only Anywhere in the document Timeframe: to: Combine searches by placing the search numbers in the top search box and pressing the search button. An example search might look like (#1 or #2) and (#3 or #4 (...) ) Loading history... Population: Intervention: Comparison: Outcome: Population: Intervention: Latest & greatest articles for fenofibrate The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence. If you
Predicting the Effect of Fenofibrate on Cardiovascular Risk for Individual Patients With Type 2 Diabetes Mellitus In clinical trials, treatment with fenofibrate did not reduce the incidence of major cardiovascular events (MCVE) in patients with type 2 diabetes mellitus (T2DM). However, treatment effects reported by trials comprise patients who respond poorly and patients who respond well to fenofibrate. Our aim was to use statistical modeling to estimate the expected treatment effect (...) of fenofibrate for individual patients with T2DM.To estimate individual risk, the FIELD risk model, with 5-year MCVE as primary outcome, was externally validated in T2DM patients from ACCORD and the SMART observational cohort. Fenofibrate treatment effect was estimated in 17,142 T2DM patients from FIELD, ACCORD, and SMART. Individual treatment effect, expressed as absolute risk reduction (ARR), is the difference between treated and untreated MCVE risk. Results were stratified for patients with and without
Association of Fenofibrate Therapy With Long-term Cardiovascular Risk in Statin-Treated Patients With Type 2 Diabetes. Patients with type 2 diabetes are at high risk of cardiovascular disease (CVD) in part owing to hypertriglyceridemia and low high-density lipoprotein cholesterol. It is unknown whether adding triglyceride-lowering treatment to statin reduces this risk.To determine whether fenofibrate reduces CVD risk in statin-treated patients with type 2 diabetes.Posttrial follow-up (...) mg/dL for women and African American individuals).Passive follow-up of study participants previously treated with fenofibrate or masked placebo.Occurrence of cardiovascular outcomes including primary composite outcome of fatal and nonfatal myocardial infarction and stroke in all participants and in prespecified subgroups.The 4644 follow-on study participants were broadly representative of the original ACCORD study population and included significant numbers of women (n = 1445; 31%), nonwhite
FIELD Substudy: Fenofibrate in Patients with Diabetes, by Gender RxFiles Trial Summary A Crawley, L Regier - Feb 2015 FIELD Substudy: Fenofibrate in Patients with Diabetes, by Gender 1 Fenofibrate Intervention and Event Lowering in Diabetes BOTTOM LINE At face value the article suggests that fenofibrate LIPIDIL should be prescribed for females with diabetes, high TGs, and low HDL. However, there are a number of factors that would warrant not adopting this as routine practice. 1) Note (...) mortality in those at high CV risk, including those with diabetes. Statins have consistently demonstrated more benefit than harm. On a somewhat related note, the ACCORD-Lipid trial found that fenofibrate failed to show additional benefit in someone with T2DM already on statin therapy. If one wants to lower CV risk in a female with diabetes, a statin would still have evidence supporting a first line role. Fenofibrate would be reasonable in a female with T2DM who was unable to take a statin, or in whom
Lipanthyl (fenofibrate) - hypertriglyceridaemia or hyperlipidaemia HAS - Medical, Economic and Public Health Assessment Division 1/11 The legally binding text is the original French version T TR RA AN NS SP PA AR RE EN NC CY Y C CO OM MM MI IT TT TE EE E Opinion 22 January 2014 LIPANTHYL 67 mg micronised, capsule B/60 (CIP 335 271-6) B/90 (CIP 335 272-2) LIPANTHYL 145 mg, film-coated tablet B/30 (CIP 369 641-0) B/90 (CIP 369 642-7) LIPANTHYL 160 mg, film-coated tablet B/30 (CIP 355 373-9) B/90 (...) (CIP 371 780-4) LIPANTHYL 200 mg micronised, capsule B/30 (CIP 332 635-7) B/90 (CIP 371 785-6) FENOFIBRATE FOURNIER 100 mg, capsule B/30 (CIP 362 756-7) FENOFIBRATE FOURNIER 300 mg, capsule B/30 (CIP 361 735-6) SECALIP 100 mg, capsule B/48 (CIP 323 764-2) SECALIP 300 mg, capsule B/30 (CIP 330 030-0) Applicant: ABBOTT PRODUCTS SAS INN fenofibrate ATC Code (2010): C10AB05 (Lipid modifying agents, plain - fibrates) Reason for the review Renewal of inclusion Extension of indication List concerned
Cholib - fenofibrate / simvastatin 27 June 2013 EMA/CHMP/308856/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Cholib International non-proprietary name: fenofibrate / simvastatine Procedure No. EMEA/H/C/002559/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile (...) BE Bioequivalence BLQ Below Limit of Quantification BMI Body Mass Index CHD Coronary Heart Disease CHF Congestive Heart Failure CI Confidence interval Cmax Maximal concentration CRP C-Reactive Protein CV Cardiovascular CVD Cardiovascular Disease CYP Cytochrome P DEHP di(2-ethylhexyl) phthalate eGFR Estimated Glomerular Filtration Rate FA Fenofibric acid FDC Fixed Dose Combination FIELD (study) Fenofibrate Intervention and Event Lowering in Diabetes FXR Farnesoid X Receptor GI Gastro intestinal HDL-C High
Benefits and safety of long-term fenofibrate therapy in people with type 2 diabetes and renal impairment: the FIELD Study Diabetic patients with moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2)) are at particular cardiovascular risk. Fenofibrate's safety in these patients is an issue because it may elevate plasma creatinine. Furthermore, guidelines regarding fenofibrate dosing in renal impairment vary internationally. We investigated fenofibrate's (...) effects on cardiovascular and end-stage renal disease (ESRD) events, according to eGFR, in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study.Type 2 diabetic patients (aged 50-75 years) with eGFR ≥30 mL/min/1.73 m(2) were randomly allocated to a fixed dose of fenofibrate (200 mg daily) (n = 4,895) or placebo (n = 4,900) for 5 years. Baseline renal function (Modification of Diet in Renal Disease equation) was grouped by eGFR (30-59, 60-89, and ≥90 mL/min/1.73 m(2
Efficacy of fenofibric Acid plus statins on multiple lipid parameters and its safety in women with mixed dyslipidemia The combination of fibrate and statin therapies may be a treatment option for women with multiple lipid abnormalities. We, therefore, initiated the present safety and efficacy analysis to address the paucity of such data in women with mixed dyslipidemia. A total of 1,393 women with mixed dyslipidemia (low-density lipoprotein [LDL] cholesterol ≥ 130 mg/dl, triglycerides [TG (...) ] ≥ 150 mg/dl, high-density lipoprotein [HDL] cholesterol <50 mg/dl), who had enrolled in any 1 of 3 randomized clinical trials, were evaluated. The eligible women were randomized to receive fenofibric acid plus a low- or moderate-dose statin (combination treatment); or low-, moderate-, or high-dose statin monotherapy; or fenofibric acid monotherapy. With low-dose combination treatment, the baseline HDL cholesterol level increased 20% and TG decreased 46% compared to an 8% HDL cholesterol increase
Pravafenix - fenofibrate / pravastatin 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 8613 E-mail firstname.lastname@example.org Website www.ema.europa.eu An agency of the European Union Assessment report for PRAVAFENIX International nonproprietary name: fenofibrate / pravastatin Procedure No. EMEA/H/C/001243 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted Pravafenix CHMP (...) ). The achievement of lipid control in mixed dyslipidaemia usually requires progressive treatment: diet and exercise, followed by pharmacological intervention with an HMG CoA reductase (statins) in monotherapy, subsequently with statins in combination with niacin or fibrates. Pravafenix 40/160 mg is a fixed dose combination (FDC) of pravastatin and fenofibrate formulated as hard capsules. Only one fixed dose combination containing 160 mg fenofibrate and 40 mg pravastatin is claimed. Fenofibrate is a fibric acid
Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy Patients with mixed hyperlipidemia and at high risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) and non-high-density lipoprotein (non-HDL) cholesterol goals on statin monotherapy. This study was designed to evaluate the efficacy and safety of a fenofibrate 160 mg/pravastatin 40 mg fixed-dose combination therapy (...) in high-risk patients not at their LDL cholesterol goal on pravastatin 40 mg. In this 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group study, after a run-in on pravastatin 40 mg, 248 patients were randomly assigned to fenofibrate/pravastatin combination therapy or to pravastatin monotherapy. Combination therapy produced significantly greater complementary decreases in non-HDL cholesterol (primary end point) than pravastatin monotherapy (-14.1% vs -6.1%, p = 0.002
Incidence and predictors of silent myocardial infarction in type 2 diabetes and the effect of fenofibrate: an analysis from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study To determine the incidence and predictors of, and effects of fenofibrate on silent myocardial infarction (MI) in a large contemporary cohort of patients with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.Routine electrocardiograms taken throughout (...) the study were assessed by Minnesota-code criteria for the presence of new Q-waves without clinical presentation and analysed with blinding to treatment allocation and clinical outcome. Of all MIs, 36.8% were silent. Being male, older age, longer diabetes duration, prior cardiovascular disease (CVD), neuropathy, higher HbA(1c), albuminuria, high serum creatinine, and insulin use all significantly predicted risk of clinical or silent MI. Fenofibrate reduced MI (clinical or silent) by 19% [hazard ratio
Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia In patients with mixed dyslipidemia characterized by increased triglycerides (TG), decreased high-density lipoprotein (HDL) cholesterol, and increased low-density lipoprotein (LDL) cholesterol, monotherapy with lipid-altering drugs often fails to achieve all lipid targets. This multicenter, double-blind, active-controlled study evaluated ABT-335 (fenofibric acid) in combination
Effect of fenofibrate on amputation events in people with type 2 diabetes mellitus (FIELD study): a prespecified analysis of a randomised controlled trial. Amputations in people with type 2 diabetes mellitus substantially impair their quality of life and impose high costs on health-care systems. Our aim was to assess the effect of fenofibrate on amputation events in a large cohort of patients with type 2 diabetes.In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, 9795 (...) patients aged 50-75 years with type 2 diabetes were randomly assigned by computer-generated randomisation sequence to receive fenofibrate 200 mg per day (n=4895) or matching placebo (n=4900) for 5 years' duration. Information about non-traumatic amputation-a prespecified tertiary endpoint of the study-was routinely gathered. Clinicians who were masked to treatment allocation adjudicated amputations as minor or major (below or above the ankle, respectively). Amputations were also classified on the basis
2009LancetControlled trial quality: predicted high
Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Laser treatment for diabetic retinopathy is often associated with visual field reduction and other ocular side-effects. Our aim was to assess whether long-term lipid-lowering therapy with fenofibrate could reduce the progression of retinopathy and the need for laser treatment in patients with type 2 diabetes mellitus.The Fenofibrate Intervention and Event Lowering (...) in Diabetes (FIELD) study was a multinational randomised trial of 9795 patients aged 50-75 years with type 2 diabetes mellitus. Eligible patients were randomly assigned to receive fenofibrate 200 mg/day (n=4895) or matching placebo (n=4900). At each clinic visit, information concerning laser treatment for diabetic retinopathy-a prespecified tertiary endpoint of the main study-was gathered. Adjudication by ophthalmologists masked to treatment allocation defined instances of laser treatment for macular
2007LancetControlled trial quality: predicted high
Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Patients with type 2 diabetes mellitus are at increased risk of cardiovascular disease, partly owing to dyslipidaemia, which can be amenable to fibrate therapy. We designed the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study to assess the effect of fenofibrate on cardiovascular disease events in these patients.We did (...) a multinational, randomised controlled trial with 9795 participants aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry. After a placebo and a fenofibrate run-in phase, we randomly assigned patients (2131 with previous cardiovascular disease and 7664 without) with a total-cholesterol concentration of 3.0-6.5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4.0 or more or plasma triglyceride of 1.0-5.0 mmol/L to micronised fenofibrate 200 mg daily (n=4895
2005LancetControlled trial quality: predicted high
Pharmacoeconomic evaluation of anti-hyperlipidemic agent fenofibrate Pharmacoeconomic evaluation of anti-hyperlipidemic agent fenofibrate Pharmacoeconomic evaluation of anti-hyperlipidemic agent fenofibrate Hayakawa T, Shimoyama K, Sekiya S, Sekiguchi M, Inotsume N Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical (...) assessment on the reliability of the study and the conclusions drawn. Health technology Fenofibrate was given to patients with type IIb or type IV hyperlipidemia who had previously been taking either bezafibrate or a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (HMG-CoA RI). Fenofibrate doses varied from 100-200mg/day. Bezafibrate doses varied from 200-400mg/day. The pravastatin dose was 10mg/day, the simvastatin dose was 5mg/day and the fluvastatin dose was 20mg/day. The study compared
Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the Diabetes Atherosclerosis Intervention Study, a randomised study. Atherosclerosis is the most common complication of diabetes. Correction of hyperglycaemia helps to prevent microvascular complications but has little effect on macrovascular disease. Post-hoc analyses of diabetic subpopulations in lipid intervention trials suggest that correction of lipoprotein abnormalities will lead to a decrease in coronary (...) -artery disease. The Diabetes Atherosclerosis Intervention Study (DAIS) was specifically designed to assess the effects of correcting lipoprotein abnormalities on coronary atherosclerosis in type 2 diabetes.731 men and women with type 2 diabetes were screened by metabolic and angiographic criteria. 418 were randomly assigned micronised fenofibrate (200 mg/day) or placebo for at least 3 years. They were in good glycaemic control (mean haemoglobin A1c 7.5%), had mild lipoprotein abnormalities, typical
2001LancetControlled trial quality: predicted high