Year Two Assessment of Fenofibric Acid and Moderate-Dose Statin Combination

Kipnes, Mark; Roth, Eli M.; Rhyne, James M.; Setze, Carolyn M.; Lele, Aditya; Kelly, Maureen; Sleep, Darryl J.; Stolzenbach, James C.

doi:10.2165/11319800-000000000-00000

Cited by 19 publications

(23 citation statements)

References 20 publications

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“…Several 12-week controlled studies of a combination of fenofibric acid with atorvastatin, rosuvastatin, or simvastatin therapy have demonstrated significant improvements in LDL-C, HDL-C, triglycerides, and non-HDL-C levels compared with prespecified monotherapies [51-55]. These benefits were maintained for up to 2 years in an open-label extension study of the combination therapies [56]. Improvements also were evident with combination therapy in a post hoc analysis of patients with type 2 diabetes mellitus [57] who comprised subsets of the populations in two 12-week controlled studies mentioned previously [52, 55].…”

Section: Resultsmentioning

confidence: 99%

A Review of Currently Available Fenofibrate and Fenofibric Acid Formulations

Ling

2013

Cardiol Res

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Fenofibrate is a third-generation fibric acid derivative indicated as a monotherapy to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B; to increase high-density lipoprotein cholesterol in patients with primary hyperlipidemia or mixed dyslipidemia; and to reduce triglycerides in patients with severe hypertriglyceridemia. In this review, the key characteristics of available fenofibrate formulations are examined. A literature search was conducted, focusing on comparative studies examining bioavailability, food effects, absorption, and lipid efficacy. Fenofibrate is highly lipophilic, virtually insoluble in water, and poorly absorbed. Coadministration with meals was necessary to maximize bioavailability of early formulations. Micronized and nanoparticle formulations of fenofibrate with reduced particle sizes were developed, resulting in greater solubility, improved bioavailability, and in some cases, the ability to be given irrespective of food. A recently introduced hydrophilic choline salt of fenofibric acid also can be taken without regard to meals, is absorbed throughout the gastrointestinal tract, has the highest bioavailability among marketed formulations, and is approved for coadministration with a statin. Differences in bioavailability of fenofibrate formulations have resulted in low-dose (40 -67) mg and standard-dose (120 -200 mg) formulations. Different formulations are not equivalent on a milligram-to-milligram basis. In order to prevent medication errors, resulting in underdosing or overdosing with attendant consequences, it is important for healthcare providers to recognize that the formulations of fenofibrate and fenofibric acid that are currently available vary substantially in relation to food effect, equivalency on a milligram-to-milligram basis, and indication to be coadministered with a statin.

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Section: Resultsmentioning

confidence: 99%

A Review of Currently Available Fenofibrate and Fenofibric Acid Formulations

Ling

2013

Cardiol Res

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“…Assessment of safety was not included in this analysis; however, long-term evaluations of the safety of rosuvastatin 20 mg and fenofibric acid in the overall population for up to 2 years of exposure have demonstrated that the combination is generally well tolerated with no new or unexpected safety concerns. 10,13 Studies have demonstrated the relative importance of hsCRP in estimating risk for cardiovascular events, as patients with lower LDL-C but hsCRP $2 mg/L were shown to have even greater risk of major cardiovascular events than patients with elevated LDL-C but normal hsCRP. 3,4 In addition to lowering LDL-C, statins have anti-inflammatory effects and lower hsCRP levels and reduce the risk for cardiovascular events; however, the hypothesis that lowering inflammation per se will reduce cardiovascular events remains to be tested.…”

Section: Discussionmentioning

confidence: 99%

Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥2 mg/L)

Ballantyne

Davidson

Setze

et al. 2011

Journal of Clinical Lipidology

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“…[27] These studies also suggest that data up to 2 years supports the safety of this combination. [28] Other treatment strategies for normalizing multiple lipid parameters in patients with mixed dyslipidemia include the addition of nicotinic acid or omega 3-fatty acids to statin therapy. Both strategies have resulted in improvements of lipid parameters other than LDL-C. [29,30] …”

Section: Studies Evaluating the Combination Of Rosuvastatinmentioning

confidence: 99%

Comparative Study of Atorvastatin and Rosuvastatin in Combination with Fenofibrate in mixed Hyperlipidemia

Dixit¹,

Jagan²

2016

IJPCS

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Aim:To compare the effects of Atorvastatin and Rosuvastatin in combination with fenofibrate in patients with mixed Hyperlipidemia. Materials and Methods: It was an open label, randomized, parallel group, comparative, prospective clinical study. A total of 70 subjects diagnosed with mixed hyperlipidemia were screened and were randomly allocated into two groups of thirty each. Initial readings of lipid levels like TC, TG, HDL, LDL and VLDL for both the groups were taken as baseline values. Then, Group I received Tab Atorvastatin 10 mg + Fenofibrate 160 mg and Group II received Tab Rosuvastatin 10 mg+ Fenofibrate 160 mg once a day at night for 12 weeks. Patients were assessed after 12 weeks and their Lipid profile was done. Results: Patients who received a combination of atorvastatin with fenofibrate had a reduction of Total cholesterol by 39%, Triglycerides by 47%, LDL-C by 50% and VLDL-C by 35% respectively. In group treated with combination of rosuvastatin with fenofibrate there was a decrease in TC by 54%, TGs by 58%, LDL-C by 52% and VLDL-C by 56% respectively. At the same time, HDL-C levels were increased by 14% in the group treated with rosuvastatin with fenofibrate as compared to atorvastatin with fenofibrate treated group which increased the HDL-C levels by 6%. Conclusion: Both the treatment regimens significantly decreased TC, TG, LDL-C, VLDL-C, but the reduction was more and statistically significant in Rosuvastatin and fenofibrate combination group when compared with atorvastatin and fenofibrate treated group at the end of 12 weeks.

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Year Two Assessment of Fenofibric Acid and Moderate-Dose Statin Combination

Abstract: This long-term study demonstrated that fenofibric acid + moderate-dose statin was generally well tolerated with no new or unexpected safety concerns, and resulted in comprehensive and sustained lipid improvements in patients with mixed dyslipidaemia.

Cited by 19 publications

References 20 publications

A Review of Currently Available Fenofibrate and Fenofibric Acid Formulations

A Review of Currently Available Fenofibrate and Fenofibric Acid Formulations

Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥2 mg/L)

Comparative Study of Atorvastatin and Rosuvastatin in Combination with Fenofibrate in mixed Hyperlipidemia

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