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Articles by Aditya Lele
Total Records ( 5 ) for Aditya Lele
  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 , Dawn M. Carlson , Thomas Dayspring , Maureen T. Kelly , Aditya Lele , Carolyn M. Setze and Darryl J. Sleep
  not available
  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.

  Debra L. Weinstein , Laura A. Williams , Dawn M. Carlson , Maureen T. Kelly , James W. Blasetto , Kim M. Burns , Carolyn M. Setze , Aditya Lele and James C. Stolzenbach
  Patients with chronic kidney disease (CKD) often have mixed dyslipidemia and are at high risk for cardiovascular (CV) disease. Although the use of statin therapy may optimize low-density lipoprotein cholesterol (LDL-C), adding a fibrate to statin therapy may further improve lipid parameters.
  Eli M. Roth , Robert S. Rosenson , Peter H. Jones , Michael H. Davidson , Maureen T. Kelly , Carolyn M. Setze , Aditya Lele and Kamlesh Thakker
 

Background

Goal/desirable lipid levels are underachieved in patients with mixed dyslipidemia. These patients may have substantial residual risk of cardiovascular disease even while receiving optimal LDL-C-lowering therapy and may require additional therapy to improve multiple lipid/lipoprotein levels.

Objective

To evaluate attainment of goal/desirable levels of lipids/lipoproteins after 12-week treatment with combination rosuvastatin + fenofibric acid versus rosuvastatin monotherapy.

Methods

This was a post hoc analysis of patients with mixed dyslipidemia who enrolled in one of two randomized controlled trials, and were treated (N = 2066) with rosuvastatin (5, 10, or 20 mg), fenofibric acid 135 mg, or rosuvastatin + fenofibric acid for 12 weeks. Data were pooled across doses of rosuvastatin as monotherapy and combination therapy.

Results

Compared with rosuvastatin monotherapy, combination therapy had comparable effects in achieving risk-stratified LDL-C goals; however, measures of total atherogenic burden were improved because significantly greater percentages of patients attained non-HDL-C goal in high- (62.9% vs 50.4%, P = .006) and moderate-risk groups (87.6% vs 80.4%, P = .016) and apolipoprotein B (ApoB) <90 mg/dL in high-risk group (59.8% vs 43.8%, P < .001). In the overall population, more patients treated with the combination therapy achieved desirable levels of HDL-C >40/50 mg/dL in men/women (P < .001), triglycerides <150 mg/dL (P < .001), and ApoB <90 mg/dL (P < .001), compared with rosuvastatin monotherapy. Furthermore, combination therapy resulted in significantly greater percentages of patients achieving simultaneous specified levels of LDL-C + non-HDL-C (P < .015); LDL-C + HDL-C + TG (P < .001); and LDL-C + HDL-C + triglycerides + non-HDL-C + ApoB (P < .001), compared with rosuvastatin monotherapy.

Conclusion

Rosuvastatin + fenofibric acid may be more efficacious than rosuvastatin alone in patients with mixed dyslipidemia.

 
 
 
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