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Fenofibrate monotherapy-induced rhabdomyolysis in a patient with hypothyroidism: A rare case report and literature review.
Wang, D, Wang, Y
Medicine. 2018;(14):e0318
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Abstract
RATIONALE Fenofibrate is a fibric acid derivative indicated for use in hypertriglyceridemia and mixed dyslipidemia treatment among adults. Rhabdomyolysis is a syndrome characterized by muscle necrosis and the release of intracellular muscle contents into the systemic circulation, which is the most serious and fatal side effect of fenofibrate. The objective of this paper is to discuss fatal side effect of fenofibrate and keep safe medication. PATIENT CONCERNS A patient with hypothyroidism who presented with rhabdomyolysis during fenofibrate monotherapy for hypertriglyceridemia was reported. DIAGNOSES Fenofibrate Monotherapy Induced Rhabdomyolysis. INTERVENTIONS Fenofibrate was stopped. Adequate fluid resuscitation, mannitol diuresis, myocardium protection, hepatoprotection and urine alkalinization with sodium bicarbonate were performed. OUTCOMES Blood tests were normal and the patient was good and discharged 2 weeks later. LESSONS 13 cases associated with fenofibrate monotherapy-induced rhabdomyolysis were reviewed, which had been published in the English literature. The severity of fenofibrate muscle toxicity may be the result of the combination of two rhabdomyolysis enhancers, such as hypothyroidism and female gender. To avoid it, strict clinical and laboratory monitoring should be maintained, particularly hypothyroidism. Patients should be informed of possible potentially irreversible effects after taking fibrates.
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Fenofibrate for Diabetic Retinopathy.
Stewart, S, Lois, N
Asia-Pacific journal of ophthalmology (Philadelphia, Pa.). 2018;(6):422-426
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Fenofibrate is a safe and inexpensive orally administered fibric acid derivative conventionally used to treat dyslipidemia. Two large randomized clinical trials, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and the Action to Control Cardiovascular Risk in Diabetes (ACCORD) studies, demonstrated the benefit of oral fenofibrate in the treatment of patients with type 2 diabetes and diabetic retinopathy (DR), including reduced disease progression and need for laser treatment for diabetic macular edema and proliferative diabetic retinopathy. These findings are supported by results of experimental studies, which have demonstrated beneficial effects of fenofibrate ameliorating retinal vascular leakage and leukostasis, downregulating vascular endothelial growth factor, and reducing endothelial cell and pericyte loss, among others; all of these are characteristic features of DR. In spite of this evidence, fenofibrate is not prescribed routinely for treating patients with diabetes and DR. In FIELD and ACCORD studies, retinopathy was not the primary outcome and this may explain, at least partly, its lack of use for this indication. New trials are now underway to specifically address the effects of fenofibrate in DR; these trials will provide additional and robust data that may support current evidence favoring the use of fenofibrate in this common microvascular complication of diabetes.
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Fenofibrate and Diabetic Retinopathy.
Knickelbein, JE, Abbott, AB, Chew, EY
Current diabetes reports. 2016;(10):90
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Diabetic retinopathy, a common and sight-threatening microvascular complication of diabetes mellitus, is a leading cause of blindness among working-aged adults. Medical therapies including intensive control of hyperglycemia and hypertension have been shown to reduce the incidence and progression of diabetic retinopathy. The association of dyslipidemia and treatment with statins with diabetic retinopathy is inconsistent in epidemiologic studies. However, two recent randomized clinical trials have demonstrated beneficial effects of systemic fenofibrate therapy in reducing the progression of diabetic retinopathy independently of serum lipid levels. These findings suggest that fenofibrate may be an effective strategy for reducing the progression of diabetic retinopathy, thus reducing the large and growing public health burden of treating the sight-threatening complications of diabetic retinopathy.
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Effect of micronized fenofibrate on microvascular complications of type 2 diabetes: a systematic review.
Czupryniak, L, Joshi, SR, Gogtay, JA, Lopez, M
Expert opinion on pharmacotherapy. 2016;(11):1463-73
Abstract
OBJECTIVE Micronized fenofibrate prevents the progression of microvascular complications in type 2 diabetes, but no systematic review has summarized these effects. Therefore, we performed a systematic review to investigate the effects of micronized fenofibrate on type 2 diabetes-related microvascular complications. RESEARCH DESIGN AND METHODS The PubMed database was systematically searched for trials in English language published between January 1990 and November 2015 that examined the effects of fenofibrate on microvascular complications in patients with type 2 diabetes. RESULTS Thirteen trials of the 290 clinical studies reviewed met the inclusion criteria. Fenofibrate significantly slowed the progression of early diabetic retinopathy by 30 to 40% within 4 to 5 years in patients with type 2 diabetes mellitus and pre-existing retinopathy at baseline. Fenofibrate also consistently reduced the progression of urinary albumin excretion in the trials studied. One large study demonstrated a significant effect (47% reduction) of the drug on diabetes-related minor amputations. CONCLUSIONS The available evidence supports the adjunctive early use of fenofibrate in type 2 diabetes mellitus for the prevention of microvascular complications, particularly in individuals presenting with the first signs of the complication and during the initial stages of the disease.
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[What is the contribution of the review of the evidence on reducing macrovascular risk in patients with atherogenic dyslipidemia? Report on consensus of experts in the importance of the combined therapy by fenofibrate with statin].
Rosolová, H
Vnitrni lekarstvi. 2015;(11):971-5
Abstract
A meeting of European experts in cardiovascular (CV) disease and lipids was convened in Paris, November 2014, where an important problem of preventive cardiology--residual vascular risk done by atherogenic dyslipidemia (AD)--was discussed. On the basis of discussion have the experts summarised a consensus concerning AD, its CV risk and up to date evidence of combined therapy with statin and fenofibrate on CV risk. Atherogenic dyslipidemia should be the secondary aim of dyslipidemia treatment, because it is a reason of residual vascular risk. Non-HDL-cholesterol should be the secondary target of AD treatment, which is a most unexpensive and easiest marker of residual vascular risk. Combined therapy with statin and fenofibrate is safe, well tolerated and reduces plasma atherogenity and CV events in patients with AD and high CV risk, type 2 diabetes or metabolic syndrome.
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Is fenofibrate a reasonable treatment for diabetic microvascular disease?
Simó, R, Simó-Servat, O, Hernández, C
Current diabetes reports. 2015;(5):24
Abstract
Type 2 diabetes is a pandemic disease, and its prevalence is increasing mainly due to an increase in obesity and life expectancy. Diabetic complications and their comorbidities constitute the most important economic cost of the disease and represent a significant economic burden for the healthcare systems of developed countries. Despite improving standards of care, people with diabetes remain at risk of the development and progression of microvascular diabetic complications. Therefore, the identification of novel therapeutic approaches is necessary. The aim of this article is to provide an overview of the clinical benefits of fenofibrate on microvascular diabetic complications, with special emphasis on diabetic retinopathy. In addition, the potential mechanisms of action will be briefly discussed.
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Plasma uric acid concentrations are reduced by fenofibrate: A systematic review and meta-analysis of randomized placebo-controlled trials.
Derosa, G, Maffioli, P, Sahebkar, A
Pharmacological research. 2015;:63-70
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BACKGROUND Hyperuricaemia increases the risk of gout, but it is also a risk factor for cardiovascular diseases. PURPOSE To conduct a systematic review and meta-analysis of relevant randomized clinical trials to ascertain the effect size of fibrates in modulating plasma uric acid concentrations. DATA SOURCES Medline (http://www.ncbi.nlm.nih.gov/pubmed), SCOPUS, Web of Science and Google Scholar databases were searched. STUDY SELECTION Studies were included if they met the following inclusion criteria: (i) being a randomized placebo-controlled trial with either parallel or cross-over design, (ii) investigating the impact of fibrate therapy on plasma uric acid concentrations, (iii) presentation of sufficient information on uric acid values at baseline and at the end of follow-up in each group or providing the net change values. DATA EXTRACTION The following data were extracted: (1) first author's name; (2) year of publication; (3) study location; (4) study design; (5) number of participants in the fibrate and placebo groups; (6) type and dose of fibrate; (7) duration of treatment; (8) age, gender and body mass index (BMI) of study participants; (9) baseline levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, high-sensitivity C-reactive protein (hs-CRP) and glucose; (10) systolic and diastolic blood pressure; and (11) data regarding baseline and follow-up uric acid. DATA SYNTHESIS There was a significant reduction in plasma uric acid concentrations following fenofibrate therapy. LIMITATIONS Few eligible studies, and most had small population sizes. CONCLUSIONS Fenofibrate, but not bezafibrate is effective in reducing serum acid uric levels.
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Should we start all patients with diabetic retinopathy on fenofibrates?
Koshy, J, Koshy, JM, Thomas, S, Kaur, G, Mathew, T
Middle East African journal of ophthalmology. 2013;(4):309-14
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There remains a need for strategies that are effective in preventing diabetic retinopathy (DR) or slowing down its progression, which is safe, well-tolerated, and more effective, have a lower risk profile, easy to perform, have more predictable results with less morbidity than the current regimens. Physicians caring for diabetic patients not only need to maximize glycemic control, but also closely monitor and treat other systemic conditions. The consistency of clinical data from the fenofibrate studies showed consistent beneficial effects with fenofibrate in slowing the progression of DR. They demonstrated significant benefit on micro-vascular (i.e., retinopathy and nephropathy) outcome, possibly independent of lipid levels. Can we combine the effectiveness of the current standard procedures with the prevention and slowing down of progression of DR that fenofibrates can offer? Knowledge of the primary mode of action of fenofibrate will be useful for both physicians and patients in determining how best to use this drug as an adjunct in the management of DR and ultimately facilitating the translation of clinical trial data to clinical practice.
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Fenofibrate - a potential systemic treatment for diabetic retinopathy?
Wong, TY, Simó, R, Mitchell, P
American journal of ophthalmology. 2012;(1):6-12
Abstract
PURPOSE To review clinical and experimental data for fenofibrate as a possible systemic treatment for diabetic retinopathy. DESIGN Perspective. METHODS Review of clinical studies focused on 2 major randomized controlled trials: the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) and ACCORD (Action to Control Cardiovascular Risk in Diabetes)-Eye studies. Progression was defined in FIELD as laser treatment for proliferative retinopathy or macular edema or increase by ≥ 2 steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, and in ACCORD-Eye as ≥ 3 steps (ETDRS scale) or proliferative disease requiring laser or vitrectomy treatment. Experimental studies investigating the mode of action of fenofibrate were reviewed. RESULTS The 2 trials included 11 388 patients with type 2 diabetes mellitus, of whom 5701 were treated with fenofibrate (± statin) for up to 5 years. Fenofibrate reduced first laser treatment by 31% (P = .0002), and progression of diabetic retinopathy with absolute reductions of 5.0% over 5 years (P = .022, FIELD) and 3.7% over 4 years (P = .006, ACCORD-Eye). There was greater benefit in patients with than without preexisting retinopathy. The putative mechanisms implicated in the mode of action of fenofibrate involve lipid and nonlipid pathways, including beneficial effects on apoptosis, oxidative stress, inflammation, blood-retinal barrier breakdown, and neuroprotection. CONCLUSIONS There are now robust and consistent clinical data to recommend fenofibrate as an adjunctive treatment for early diabetic retinopathy in patients with type 2 diabetes mellitus, taking into account the risks vs benefits of therapy. Further elucidating its mode of action will help to refine how best to use fenofibrate in the management of diabetic retinopathy.
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Prevention and treatment of diabetic retinopathy: evidence from large, randomized trials. The emerging role of fenofibrate.
Simó, R, Hernández, C
Reviews on recent clinical trials. 2012;(1):71-80
Abstract
Diabetic retinopathy (DR) remains a leading cause of preventable vision loss, despite advances in diabetes care. The burden of DR is likely to increase as the evolving pandemic of type 2 diabetes progresses. Tight control of blood glucose levels and blood pressure are essential for preventing or arresting the development of diabetic retinopathy, but are often difficult to achieve, and DR thus develops in a high proportion of patients. Current treatments for DR such as laser photocoagulation, intravitreous injections of corticosteroids or anti-vascular endothelial growth factor (VEGF) agents are indicated for advanced DR and have significant adverse effects. Therefore, new pharmacological treatments for the early stages of DR are needed. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial included a lipid management arm, in which patients satisfying additional inclusion criteria for the atherogenic dyslipidemia phenotype were randomly assigned to fenofibrate or placebo, each with a statin. In the ACCORD-EYE substudy, randomization to fenofibrate was associated with a significant reduction in the risk of progression of DR. These data confirm and extend the results of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, in which type 2 diabetes patients randomized to fenofibrate benefitted from a significantly lower incidence of laser treatment for retinopathy, progression of retinopathy or a composite measure of retinopathy outcomes. The results of ACCORD-EYE, together with those of FIELD, identify a place for fenofibrate for the prevention of retinopathy alongside intensive management of traditional risk factors, such as hyperglycemia and high blood pressure.