A Review of Time Courses and Predictors of Lipid Changes with Fenofibric Acid-Statin Combination

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Abstract

Fibrates activate peroxisome proliferator activated receptor α and exert beneficial effects on triglycerides, high-density lipoprotein cholesterol, and low density lipoprotein subspecies. Fenofibric acid (FA) has been studied in a large number of patients with mixed dyslipidemia, combined with a low- or moderate-dose statin. The combination of FA with simvastatin, atorvastatin and rosuvastatin resulted in greater improvement of the overall lipid profile compared with the corresponding statin dose. The long-term efficacy of FA combined with low- or moderate- dose statin has been demonstrated in a wide range of patients, including patients with type 2 diabetes mellitus, metabolic syndrome, or elderly subjects. The FA and statin combination seems to be a reasonable option to further reduce cardiovascular risk in high-risk populations, although trials examining cardiovascular disease events are missing.

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Most cited references 77

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Statin-associated myopathy.

Paul Thompson, Priscilla M. Clarkson, Richard H. Karas (2003)

Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are associated with skeletal muscle complaints, including clinically important myositis and rhabdomyolysis, mild serum creatine kinase (CK) elevations, myalgia with and without elevated CK levels, muscle weakness, muscle cramps, and persistent myalgia and CK elevations after statin withdrawal. We performed a literature review to provide a clinical summary of statin-associated myopathy and discuss possible mediating mechanisms. We also update the US Food and Drug Administration (FDA) reports on statin-associated rhabdomyolysis. Articles on statin myopathy were identified via a PubMed search through November 2002 and articles on statin clinical trials, case series, and review articles were identified via a PubMed search through January 2003. Adverse event reports of statin-associated rhabdomyolysis were also collected from the FDA MEDWATCH database. The literature review found that reports of muscle problems during statin clinical trials are extremely rare. The FDA MEDWATCH Reporting System lists 3339 cases of statin-associated rhabdomyolysis reported between January 1, 1990, and March 31, 2002. Cerivastatin was the most commonly implicated statin. Few data are available regarding the frequency of less-serious events such as muscle pain and weakness, which may affect 1% to 5% of patients. The risk of rhabdomyolysis and other adverse effects with statin use can be exacerbated by several factors, including compromised hepatic and renal function, hypothyroidism, diabetes, and concomitant medications. Medications such as the fibrate gemfibrozil alter statin metabolism and increase statin plasma concentration. How statins injure skeletal muscle is not clear, although recent evidence suggests that statins reduce the production of small regulatory proteins that are important for myocyte maintenance.

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Safety considerations with fibrate therapy.

Mary Jacobson, Annemarie Armani, Richard McKenney … (2007)

Fibrates are an important class of drugs for the management of dyslipidemia. This class of drugs is generally well tolerated but is infrequently associated with several safety issues. Fibrates, most likely by an effect mediated by peroxisome proliferator-activated receptor-alpha, may reversibly increase creatinine and homocysteine but are not associated with an increased risk for renal failure in clinical trials. Fibrates are associated with a slightly increased risk (<1.0%) for myopathy, cholelithiasis, and venous thrombosis. In clinical trials, patients without elevated triglycerides and/or low high-density lipoprotein cholesterol (HDL) levels, fibrates are associated with an increase in noncardiovascular mortality. In combination with statins, gemfibrozil generally should be avoided. The preferred option is fenofibrate, which is not associated with an inhibition of statin metabolism. Clinicians are advised to measure serum creatinine before fibrate use and adjust the dose accordingly for renal impairment. Routine monitoring of creatinine is not required, but if a patient has a clinically important increase in creatinine, and other potential causes of creatinine increase have been excluded, consideration should be given to discontinuing fibrate therapy or reducing the dose.

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The Residual Risk Reduction Initiative: A Call to Action to Reduce Residual Vascular Risk in Patients with Dyslipidemia

Jean-Charles Fruchart, Frank Sacks, Michel Hermans … (2008)

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Author and article information

Contributors

: +30-2651002397 , filtheo@gmail.com

Journal

Journal ID (nlm-ta): Cardiovasc Drugs Ther

Journal ID (iso-abbrev): Cardiovasc Drugs Ther

Title: Cardiovascular Drugs and Therapy

Publisher: Springer US (Boston )

ISSN (Print): 0920-3206

ISSN (Electronic): 1573-7241

Publication date (Electronic): 17 May 2012

Publication date PMC-release: 17 May 2012

Publication date (Print): June 2012

Volume: 26

Issue: 3

Pages: 245-255

Affiliations

Department of Internal Medicine, School of Medicine, University of Ioannina, 45110 Ioannina, Greece

Article

Publisher ID: 6394

DOI: 10.1007/s10557-012-6394-0

PMC ID: 3368211

PubMed ID: 22592524

SO-VID: 6c3cbda2-8e6a-4ff5-b043-e49f80f72662

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ScienceOpen disciplines: Cardiovascular Medicine

Keywords: high-density lipoprotein cholesterol,statin,fenofibric acid,atorvastatin,rosuvastatin,fibrate,simvastatin,triglycerides

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ScienceOpen disciplines: Cardiovascular Medicine

Keywords: high-density lipoprotein cholesterol, statin, fenofibric acid, atorvastatin, rosuvastatin, fibrate, simvastatin, triglycerides

A Review of Time Courses and Predictors of Lipid Changes with Fenofibric Acid-Statin Combination

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Abstract

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Cardiovascular Innovations and Applications

Most cited references 77

Statin-associated myopathy.

Safety considerations with fibrate therapy.

The Residual Risk Reduction Initiative: A Call to Action to Reduce Residual Vascular Risk in Patients with Dyslipidemia

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