Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia

Harold E. Bays, Peter H. Jones, Syed M. Mohiuddin, Maureen T. Kelly, Hsiaoming Sun, Carolyn M. Setze, Susan M. Buttler, Darryl J. Sleep, James C. Stolzenbach

Research output: Contribution to journalArticle

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Abstract

Background: Co-administration of a fibrate and statin is an effective treatment option for patients with multiple lipid abnormalities, yet adequate long-term safety and efficacy data are lacking. Objective: To evaluate the long-term safety and efficacy of fenofibric acid combined with statins in adults with mixed dyslipidemia. Methods: Three large, 12-week, phase three, double-blind, randomized, controlled trials evaluated fenofibric acid 135 mg combined with a low- or moderate-dose statin compared to fenofibric acid or statin monotherapy, and a subsequent 52-week open-label extension study evaluated fenofibric acid 135 mg combined with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg). This prespecified analysis integrated results from these studies to assess the long-term safety and efficacy of combination therapy. Results: Across the controlled studies and the extension study, 2201 patients received at least one dose of fenofibric acid + statin for a median duration of 364 days. The most common adverse events were headache, upper respiratory tract infection, nasopharyngitis, and back pain, with the incidence of all adverse events being similar across all combination therapy treatment groups. Rhabdomyolysis or treatment-related death was not reported in any group. Combination therapy resulted in sustained improvements in multiple lipid parameters, including triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein. Conclusion: Long-term fenofibric acid + statin combination therapy was generally well tolerated and resulted in comprehensive and sustained improvements in multiple lipid parameters in adults with mixed dyslipidemia.

Original languageEnglish
Pages (from-to)426-435
Number of pages10
JournalJournal of Clinical Lipidology
Volume2
Issue number6
DOIs
StatePublished - Dec 2008

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Dyslipidemias
Safety
Lipids
Therapeutics
Nasopharyngitis
Multiple Abnormalities
Fibric Acids
VLDL Cholesterol
Rhabdomyolysis
Simvastatin
Apolipoproteins B
Back Pain
Group Psychotherapy
fenofibric acid
Respiratory Tract Infections
C-Reactive Protein
LDL Cholesterol
HDL Cholesterol
Headache

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine
  • Nutrition and Dietetics

Cite this

Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia. / Bays, Harold E.; Jones, Peter H.; Mohiuddin, Syed M.; Kelly, Maureen T.; Sun, Hsiaoming; Setze, Carolyn M.; Buttler, Susan M.; Sleep, Darryl J.; Stolzenbach, James C.

In: Journal of Clinical Lipidology, Vol. 2, No. 6, 12.2008, p. 426-435.

Research output: Contribution to journalArticle

Bays, Harold E. ; Jones, Peter H. ; Mohiuddin, Syed M. ; Kelly, Maureen T. ; Sun, Hsiaoming ; Setze, Carolyn M. ; Buttler, Susan M. ; Sleep, Darryl J. ; Stolzenbach, James C. / Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia. In: Journal of Clinical Lipidology. 2008 ; Vol. 2, No. 6. pp. 426-435.
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abstract = "Background: Co-administration of a fibrate and statin is an effective treatment option for patients with multiple lipid abnormalities, yet adequate long-term safety and efficacy data are lacking. Objective: To evaluate the long-term safety and efficacy of fenofibric acid combined with statins in adults with mixed dyslipidemia. Methods: Three large, 12-week, phase three, double-blind, randomized, controlled trials evaluated fenofibric acid 135 mg combined with a low- or moderate-dose statin compared to fenofibric acid or statin monotherapy, and a subsequent 52-week open-label extension study evaluated fenofibric acid 135 mg combined with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg). This prespecified analysis integrated results from these studies to assess the long-term safety and efficacy of combination therapy. Results: Across the controlled studies and the extension study, 2201 patients received at least one dose of fenofibric acid + statin for a median duration of 364 days. The most common adverse events were headache, upper respiratory tract infection, nasopharyngitis, and back pain, with the incidence of all adverse events being similar across all combination therapy treatment groups. Rhabdomyolysis or treatment-related death was not reported in any group. Combination therapy resulted in sustained improvements in multiple lipid parameters, including triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein. Conclusion: Long-term fenofibric acid + statin combination therapy was generally well tolerated and resulted in comprehensive and sustained improvements in multiple lipid parameters in adults with mixed dyslipidemia.",
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T1 - Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia

AU - Bays, Harold E.

AU - Jones, Peter H.

AU - Mohiuddin, Syed M.

AU - Kelly, Maureen T.

AU - Sun, Hsiaoming

AU - Setze, Carolyn M.

AU - Buttler, Susan M.

AU - Sleep, Darryl J.

AU - Stolzenbach, James C.

PY - 2008/12

Y1 - 2008/12

N2 - Background: Co-administration of a fibrate and statin is an effective treatment option for patients with multiple lipid abnormalities, yet adequate long-term safety and efficacy data are lacking. Objective: To evaluate the long-term safety and efficacy of fenofibric acid combined with statins in adults with mixed dyslipidemia. Methods: Three large, 12-week, phase three, double-blind, randomized, controlled trials evaluated fenofibric acid 135 mg combined with a low- or moderate-dose statin compared to fenofibric acid or statin monotherapy, and a subsequent 52-week open-label extension study evaluated fenofibric acid 135 mg combined with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg). This prespecified analysis integrated results from these studies to assess the long-term safety and efficacy of combination therapy. Results: Across the controlled studies and the extension study, 2201 patients received at least one dose of fenofibric acid + statin for a median duration of 364 days. The most common adverse events were headache, upper respiratory tract infection, nasopharyngitis, and back pain, with the incidence of all adverse events being similar across all combination therapy treatment groups. Rhabdomyolysis or treatment-related death was not reported in any group. Combination therapy resulted in sustained improvements in multiple lipid parameters, including triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein. Conclusion: Long-term fenofibric acid + statin combination therapy was generally well tolerated and resulted in comprehensive and sustained improvements in multiple lipid parameters in adults with mixed dyslipidemia.

AB - Background: Co-administration of a fibrate and statin is an effective treatment option for patients with multiple lipid abnormalities, yet adequate long-term safety and efficacy data are lacking. Objective: To evaluate the long-term safety and efficacy of fenofibric acid combined with statins in adults with mixed dyslipidemia. Methods: Three large, 12-week, phase three, double-blind, randomized, controlled trials evaluated fenofibric acid 135 mg combined with a low- or moderate-dose statin compared to fenofibric acid or statin monotherapy, and a subsequent 52-week open-label extension study evaluated fenofibric acid 135 mg combined with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg). This prespecified analysis integrated results from these studies to assess the long-term safety and efficacy of combination therapy. Results: Across the controlled studies and the extension study, 2201 patients received at least one dose of fenofibric acid + statin for a median duration of 364 days. The most common adverse events were headache, upper respiratory tract infection, nasopharyngitis, and back pain, with the incidence of all adverse events being similar across all combination therapy treatment groups. Rhabdomyolysis or treatment-related death was not reported in any group. Combination therapy resulted in sustained improvements in multiple lipid parameters, including triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein. Conclusion: Long-term fenofibric acid + statin combination therapy was generally well tolerated and resulted in comprehensive and sustained improvements in multiple lipid parameters in adults with mixed dyslipidemia.

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