TY - JOUR
T1 - Efficacy and safety of fenofibric acid in combination with a statin in patients with mixed dyslipidemia
T2 - Pooled analysis of three phase 3, 12-week randomized, controlled studies
AU - Jones, Peter H.
AU - Davidson, Michael H.
AU - Goldberg, Anne C.
AU - Pepine, Carl J.
AU - Kelly, Maureen T.
AU - Buttler, Susan M.
AU - Setze, Carolyn M.
AU - Lele, Aditya
AU - Sleep, Darryl J.
AU - Stolzenbach, James C.
N1 - Funding Information:
Dr. Peter Jones has served as a consultant, member of advisory panels, and/or member of speakers' bureaus for Abbott, AstraZeneca, GlaxoSmithKline, and MerckScheringPlough. Dr. Michael Davidson has received grant/research support, honoraria, and/or served as a consultant, member of speakers' bureaus, and/or member of advisory boards for Abbott, Oscient Pharmaceuticals, Access Health, Pfizer Laboratories, AstraZeneca Pharmaceuticals, PreEmptive Meds, Atherogenics, Roche Pharmaceuticals, Daiichi-Sankyo, Sankyo, diaDexus, Sanofi-Aventis, GlaxoSmithKline, Synarc, Kinemed, Takeda Pharmaceuticals, Merck & Co., Merck/Schering-Plough, and Xinthria Pharmaceuticals. Dr. Anne Goldberg has served as a consultant, member of advisory panels, and/or member of speakers' bureaus for Abbott, MerckScheringPlough, Roche, and Sanofi-Aventis. Dr. Carl Pepine has received consulting fees/honoraria, research grants, and/or other financial support from Abbott, The Medicines Company, Reliant Pharmaceuticals, Novartis, Merck, Forest Laboratories, Daiichi-Sankyo, Lilly, Boehringer Ingelheim, Wyeth-Ayerst, Viron Therapeutics, Schering-Plough, Sanofi-Aventis, Pfizer, GlaxoSmithKline, CV Therapeutics, Berlex, and AstraZeneca. Dr. Maureen Kelly, Susan Buttler, Carolyn Setze, Aditya Lele, Dr. Darryl Sleep, and Dr. James Stolzenbach are employees of Abbott. ClinicalTrials.gov identifiers: NCT00300482, NCT00300456, NCT00300469.
Funding Information:
Financial support for the studies was provided by Abbott. We acknowledge Rachelle Weiss, PhD, and Heather McComas, PharmD, who provided medical writing support on behalf of Abbott, and Tamara L. Dillberg, RN, MSN, and Debra Schuerr, BS, for assistance with clinical study management. We also thank all investigators and patients who participated in the studies.
PY - 2009/4
Y1 - 2009/4
N2 - 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.
AB - 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.
KW - Data pooling
KW - Dyslipidemia
KW - Fenofibric acid
KW - Fibrates
KW - HDL cholesterol
KW - Hydroxymethylglutaryl-CoA reductase inhibitors
KW - LDL cholesterol
KW - Triglycerides
UR - http://www.scopus.com/inward/record.url?scp=62549159657&partnerID=8YFLogxK
U2 - 10.1016/j.jacl.2009.02.007
DO - 10.1016/j.jacl.2009.02.007
M3 - Article
C2 - 21291802
AN - SCOPUS:62549159657
SN - 1933-2874
VL - 3
SP - 125
EP - 137
JO - Journal of Clinical Lipidology
JF - Journal of Clinical Lipidology
IS - 2
ER -