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Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia.
Am J Cardiol. 2009 Feb 15; 103(4):515-22.AJ

Abstract

In patients with mixed dyslipidemia characterized by increased triglycerides (TG), decreased high-density lipoprotein (HDL) cholesterol, and increased low-density lipoprotein (LDL) cholesterol, monotherapy with lipid-altering drugs often fails to achieve all lipid targets. This multicenter, double-blind, active-controlled study evaluated ABT-335 (fenofibric acid) in combination with 2 doses of atorvastatin in patients with mixed dyslipidemia. A total of 613 patients with LDL cholesterol > or =130 mg/dl, TG > or =150 mg/dl, and HDL cholesterol <40 mg/dl for men and <50 mg/dl for women were randomly assigned to ABT-335 (135 mg), atorvastatin (20, 40, or 80 mg), or combination therapy (ABT-335 + atorvastatin 20 or 40 mg) and treated for 12 weeks. Combination therapy with ABT-335 + atorvastatin 20 mg resulted in significantly greater improvements in TG (-45.6% vs -16.5%) and HDL cholesterol (14.0% vs 6.3%) compared with atorvastatin 20 mg and LDL cholesterol (-33.7% vs -3.4%) compared with ABT-335. Similarly, significantly greater improvements were observed with ABT-335 + atorvastatin 40 mg in TG (-42.1% vs -23.2%) and HDL cholesterol (12.6% vs 5.3%) compared with atorvastatin 40 mg and LDL cholesterol (-35.4% vs -3.4%) compared with ABT-335 monotherapy. Combination therapy also improved multiple secondary variables. Combination therapy was generally well tolerated with a safety profile consistent with those of ABT-335 and atorvastatin monotherapies. No rhabdomyolysis was reported. In conclusion, ABT-335 + atorvastatin combination therapy resulted in more effective control of multiple lipid parameters than either monotherapy and may be an appropriate therapy for patients with mixed dyslipidemia.

Authors+Show Affiliations

Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA. agoldber@im.wustl.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19195513

Citation

Goldberg, Anne C., et al. "Efficacy and Safety of ABT-335 (fenofibric Acid) in Combination With Atorvastatin in Patients With Mixed Dyslipidemia." The American Journal of Cardiology, vol. 103, no. 4, 2009, pp. 515-22.
Goldberg AC, Bays HE, Ballantyne CM, et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. Am J Cardiol. 2009;103(4):515-22.
Goldberg, A. C., Bays, H. E., Ballantyne, C. M., Kelly, M. T., Buttler, S. M., Setze, C. M., Sleep, D. J., & Stolzenbach, J. C. (2009). Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. The American Journal of Cardiology, 103(4), 515-22. https://doi.org/10.1016/j.amjcard.2008.10.025
Goldberg AC, et al. Efficacy and Safety of ABT-335 (fenofibric Acid) in Combination With Atorvastatin in Patients With Mixed Dyslipidemia. Am J Cardiol. 2009 Feb 15;103(4):515-22. PubMed PMID: 19195513.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. AU - Goldberg,Anne C, AU - Bays,Harold E, AU - Ballantyne,Christie M, AU - Kelly,Maureen T, AU - Buttler,Susan M, AU - Setze,Carolyn M, AU - Sleep,Darryl J, AU - Stolzenbach,James C, Y1 - 2008/12/26/ PY - 2008/05/24/received PY - 2008/10/10/revised PY - 2008/10/10/accepted PY - 2009/2/7/entrez PY - 2009/2/7/pubmed PY - 2009/3/20/medline SP - 515 EP - 22 JF - The American journal of cardiology JO - Am J Cardiol VL - 103 IS - 4 N2 - In patients with mixed dyslipidemia characterized by increased triglycerides (TG), decreased high-density lipoprotein (HDL) cholesterol, and increased low-density lipoprotein (LDL) cholesterol, monotherapy with lipid-altering drugs often fails to achieve all lipid targets. This multicenter, double-blind, active-controlled study evaluated ABT-335 (fenofibric acid) in combination with 2 doses of atorvastatin in patients with mixed dyslipidemia. A total of 613 patients with LDL cholesterol > or =130 mg/dl, TG > or =150 mg/dl, and HDL cholesterol <40 mg/dl for men and <50 mg/dl for women were randomly assigned to ABT-335 (135 mg), atorvastatin (20, 40, or 80 mg), or combination therapy (ABT-335 + atorvastatin 20 or 40 mg) and treated for 12 weeks. Combination therapy with ABT-335 + atorvastatin 20 mg resulted in significantly greater improvements in TG (-45.6% vs -16.5%) and HDL cholesterol (14.0% vs 6.3%) compared with atorvastatin 20 mg and LDL cholesterol (-33.7% vs -3.4%) compared with ABT-335. Similarly, significantly greater improvements were observed with ABT-335 + atorvastatin 40 mg in TG (-42.1% vs -23.2%) and HDL cholesterol (12.6% vs 5.3%) compared with atorvastatin 40 mg and LDL cholesterol (-35.4% vs -3.4%) compared with ABT-335 monotherapy. Combination therapy also improved multiple secondary variables. Combination therapy was generally well tolerated with a safety profile consistent with those of ABT-335 and atorvastatin monotherapies. No rhabdomyolysis was reported. In conclusion, ABT-335 + atorvastatin combination therapy resulted in more effective control of multiple lipid parameters than either monotherapy and may be an appropriate therapy for patients with mixed dyslipidemia. SN - 1879-1913 UR - https://www.unboundmedicine.com/medline/citation/19195513/Efficacy_and_safety_of_ABT_335__fenofibric_acid__in_combination_with_atorvastatin_in_patients_with_mixed_dyslipidemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9149(08)01893-6 DB - PRIME DP - Unbound Medicine ER -