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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
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
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
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
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
Effect of fenofibrate on uric acid level in patients with gout Gout is a chronic disease associated with deposition of monosodium urate crystals and accompanied by diabetes, hypertension, and dyslipidemia. Hypertriglyceridemia is common among patients with gout, and fenofibrate is usually used to reduce triglyceride levels. The aim of this study is to determine the effect of uric acid reduction by fenofibrate in patients with gout administered uric acid lowering agents (viz., the xanthine (...) oxidase inhibitors allopurinol and febuxostat). Data from 863 patients with gout were collected from electronic medical records comprising information on underlying diseases, laboratory findings, and drug histories. Among all the patients, 70 (8.11%) took fenofibrate with allopurinol or febuxostat. Male and young patients took fenofibrate more frequently, and hypertension was less frequent in patients administered xanthine oxidase inhibitors and fenofibrate than in those administered only xanthine
New Fixed-Dose Combinations of Fenofibrate/Simvastatin Therapy Significantly Improve the Lipid Profile of High-Risk Patients with Mixed Dyslipidemia Versus Monotherapies. Guidelines propose additional therapy to statin to treat elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDLC) in dyslipidemic patients. We evaluated the effects of new fixed-dose combinations (FDC) of fenofibrate/simvastatin on plasma lipids versus simvastatin or fenofibrate monotherapies.Subjects (...) with mixed dyslipidemia at high or very high cardiovascular risk on stable statin therapy for at least 3 months were included in a randomized, double-blind, active-control, parallel-group study. Patients were treated with FDC fenofibrate/simvastatin 145/20 mg or 145/40 mg, simvastatin 20 mg or 40 mg, or fenofibrate 145 mg for 12 weeks. Plasma lipids, C-reactive protein, and cystatin C were measured before and after treatments. Differences in % changes were compared between FDC fenofibrate/simvastatin
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
Comparison of fenofibrate and pioglitazone effects on patients with nonalcoholic fatty liver disease. Nonalcoholic fatty liver disease (NAFLD) is known to be a health-related problem; there is no proven treatment for NAFLD. However, a wide range of possible therapies have been proposed and studied. In the current study, we aimed to compare the therapeutic effects of fenofibrate and pioglitazone on NAFLD.In this randomized clinical trial study (ethic number: ZUMS.REC.1393.133), patients (...) with NAFLD and alanine aminotransferase in range of 1-1.5 folds of normal and BMI (25-35) were studied. Blood lipids and liver enzymes were measured. The patients were divided randomly into three groups (recipient of fenofibrate, pioglitazone, and exercise). After the patients completed the course of treatment, liver enzymes were measured.According to the results of this study, 90 patients with NAFLD were divided into three groups of 30 patients. All variables at the beginning of the study showed
Effect of fenofibrate on uric acid and gout in type 2 diabetes: a post-hoc analysis of the randomised, controlled FIELD study. Gout is a painful disorder and is common in type 2 diabetes. Fenofibrate lowers uric acid and reduces gout attacks in small, short-term studies. Whether fenofibrate produces sustained reductions in uric acid and gout attacks is unknown.In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial, participants aged 50-75 years with type 2 diabetes were (...) randomly assigned to receive either co-micronised fenofibrate 200 mg once per day or matching placebo for a median of 5 years follow-up. We did a post-hoc analysis of recorded on-study gout attacks and plasma uric acid concentrations according to treatment allocation. The outcomes of this analysis were change in uric acid concentrations and risk of on-study gout attacks. The FIELD study is registered with ISRCTN, number ISRCTN64783481.Between Feb 23, 1998, and Nov 3, 2000, 9795 patients were randomly
Effects of combination treatment using anti-hyperuricaemic agents with fenofibrate and/or losartan on uric acid metabolism. To assess the effect of a combination treatment using anti-hyperuricaemic agents with fenofibrate and/or losartan on uric acid metabolism in hypertriglyceridaemic and/or hypertensive patients with gout.Twenty seven patients with gout were included in a fenofibrate plus anti-hyperuricaemic agents combination study, and 25 in a losartan plus anti-hyperuricaemic agents (...) combination study. Serum uric acid concentration, uric acid clearance, and 24 hour urinary uric acid excretion were measured before and two months after the addition of fenofibrate (300 mg once daily) or losartan (50 mg once daily) to anti-hyperuricaemic agents.Combination therapy of fenofibrate or losartan with anti-hyperuricaemic agents, which included benzbromarone (50 mg once daily) or allopurinol (200 mg twice a day), significantly reduced serum uric acid concentrations in accordance with increased
Rationale for an adjunctive therapy with fenofibrate in pharmacoresistant nocturnal frontal lobe epilepsy. Nocturnal frontal lobe epilepsy (NFLE) is an idiopathic partial epilepsy with a family history in about 25% of cases, with autosomal dominant inheritance (autosomal dominant NFLE [ADNFLE]). Traditional antiepileptic drugs are effective in about 55% of patients, whereas the rest remains refractory. One of the key pathogenetic mechanisms is a gain of function of neuronal nicotinic (...) acetylcholine receptors (nAChRs) containing the mutated α4 or β2 subunits. Fenofibrate, a common lipid-regulating drug, is an agonist at peroxisome proliferator-activated receptor alpha (PPARα) that is a ligand-activated transcription factor, which negatively modulates the function of β2-containing nAChR. To test clinical efficacy of adjunctive therapy with fenofibrate in pharmacoresistant ADNFLE\NFLE patients, we first demonstrated the effectiveness of fenofibrate in a mutated mouse model displaying both
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
Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. In the FIELD study, comparison of the effect of fenofibrate on cardiovascular disease (CVD) between those with prior CVD and without was a prespecified subgroup analysis.The effects of fenofibrate on total CVD events and its components in patients who did (n = 2,131) and did not (n = 7,664) have (...) , and higher rates of use of insulin and CVD medications. Discontinuation of fenofibrate was similar between the subgroups, but more patients with prior CVD than without, and also more placebo than fenofibrate-assigned patients, commenced statin therapy. The borderline difference in the effects of fenofibrate between those who did (hazard ratio [HR] 1.02, 95% CI 0.86-1.20) and did not have prior CVD (HR 0.81, 95% CI 0.70-0.94; heterogeneity P = .045) became nonsignificant after adjustment for baseline
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
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
Fenofibrate for diabetic retinopathy [Cochrane protocol] Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g. "Dr Smith
Efficacy of Fenofibrate for diabetic retinopathy(DRP): a systematic review protocol Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email
Efficacy and Safety of Alternate Day Therapy With Atorvastatin and Fenofibrate Combination in Mixed Dyslipidemia: A Randomized Controlled Trial. The long half-life of atorvastatin and fenofibrate makes them suitable for alternate day therapy. Hence, we aimed to study the efficacy, safety, and cost-effectiveness of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia.Eligible patients with mixed dyslipidemia were randomly allotted into 2 equal parallel groups (...) -alternate day therapy group (group 1) and daily therapy group (group 2). Patients in groups 1 and 2 received fixed dose combination of atorvastatin 10 mg and fenofibrate 160 mg on alternate days and daily, respectively, for 12 weeks. Mean percentage change from baseline in triglycerides (TGLs), non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and TC-HDL ratio, incidence of adverse effects, and cost-effectiveness were
Safety, tolerability, and efficacy of simvastatin and fenofibrate--a multicenter study. Simvastatin-Fenofibrate Study Group. Five centers participated in a double-blind, randomized, active-drug controlled study. The selected patients had a diagnosis of primary hypercholesterolemia (phenotype IIa or IIb, total cholesterol [TC] greater than 300 mg/dl, low-density lipoprotein [LDL] cholesterol greater than 195 mg/dl, triglycerides [TG] less than 350 mg/dl). Throughout the study the patients (...) observed a lipid-lowering diet (American Heart Association). After a baseline placebo period (4 weeks), the patients were randomly assigned to simvastatin 20 mg q.p.m. or fenofibrate 200 mg b.i.d. If after 6 weeks of treatment the LDL cholesterol level remained over 140 mg/dl the dose of simvastatin was doubled. The total duration of treatment was 10 weeks. One hundred eighty-four patients completed the study; age ranged from 17 to 72 years (mean 46; 129 men, 55 women). Seventy-nine patients had