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Articles by Darryl J. Sleep
Total Records ( 5 ) for Darryl J. Sleep
  Michael H. Davidson , Dawn M. Carlson , Robert M. Guthrie , Maureen T. Kelly , Aditya Lele , Carolyn M. Setze and Darryl J. Sleep
  not available
  Peter H. Jones , Susan M. Buttler , Michael H. Davidson , Moti L. Kashyap , Maureen T. Kelly , Carolyn M. Setze , Darryl J. Sleep and James C. Stolzenbach
  not available
  Peter H. Jones , Dawn M. Carlson , Thomas Dayspring , Maureen T. Kelly , Aditya Lele , Carolyn M. Setze and Darryl J. Sleep
  not available
  Harold E. Bays , Peter H. Jones , Syed M. Mohiuddin , Maureen T. Kelly , Hsiaoming Sun , Carolyn M. Setze , Susan M. Buttler , Darryl J. Sleep and James C. Stolzenbach
 

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.

  Peter H. Jones , Michael H. Davidson , Anne C. Goldberg , Carl J. Pepine , Maureen T. Kelly , Susan M. Buttler , Carolyn M. Setze , Aditya Lele , Darryl J. Sleep and James C. Stolzenbach
 

Background

Patients with mixed dyslipidemia often require combination therapy to manage multiple lipid abnormalities.

Objective

To evaluate fenofibric acid in combination with a statin across three studies of patients with mixed dyslipidemia.

Methods

As prospectively planned, data were pooled from three randomized, double-blind, phase 3 studies of patients with low-density lipoprotein cholesterol (LDL-C) ≥130 mg/dL, triglycerides (TG) ≥150 mg/dL, and high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (men) or <50 mg/dL (women). A total of 2715 patients were randomly assigned to 12-week treatment with fenofibric acid 135 mg monotherapy; low-, moderate-, or high-dose statin (rosuvastatin, simvastatin, or atorvastatin, depending on study) monotherapy; or fenofibric acid + low- or moderate-dose statin. The primary efficacy comparisons were mean percent change in HDL-C and TG (combination therapy vs. statin) and LDL-C (combination therapy vs. fenofibric acid).

Results

Fenofibric acid + low-dose statin increased HDL-C (18.1% vs. 7.4%) and reduced TG (−43.9% vs. −16.8%) versus low-dose statin monotherapy and reduced LDL-C (−33.1% vs. −5.1%) versus fenofibric acid monotherapy (P <.001 for all). Fenofibric acid + moderate-dose statin increased HDL-C (17.5% vs. 8.7%) and reduced TG (−42.0% vs. −23.7%) versus moderate-dose statin monotherapy and reduced LDL-C (−34.6% vs. −5.1%) versus fenofibric acid monotherapy (P <.001 for all). Combination therapy was generally well tolerated, and safety profiles were similar to monotherapies. No rhabdomyolysis was reported.

Conclusion

In patients with mixed dyslipidemia, combination therapy simultaneously improved multiple lipid abnormalities more effectively than fenofibric acid or statin monotherapies.

 
 
 
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