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Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia.
Am Heart J. 2010 Oct; 160(4):759-66.AH

Abstract

BACKGROUND

Statin and ezetimibe combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia.

METHODS

In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides ≥150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C ≥130 mg/dL were randomized to 12 weeks of treatment with fenofibric acid 135 mg (FA) or placebo, each coadministered with atorvastatin 40 mg + ezetimibe 10 mg (Atorva/Eze).

RESULTS

Both treatment regimens lowered LDL-C by >50%; however, FA + Atorva/Eze resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with Atorva/Eze. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination.

CONCLUSIONS

In patients with mixed dyslipidemia, the combination of FA + Atorva/Eze significantly improved lipid and nonlipid parameters compared with Atorva/Eze and was generally well tolerated.

Authors+Show Affiliations

Baylor College of Medicine, Houston, TX 77030, USA. jones@bcm.tmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20934572

Citation

Jones, Peter H., et al. "Efficacy and Safety of Fenofibric Acid in Combination With Atorvastatin and Ezetimibe in Patients With Mixed Dyslipidemia." American Heart Journal, vol. 160, no. 4, 2010, pp. 759-66.
Jones PH, Goldberg AC, Knapp HR, et al. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010;160(4):759-66.
Jones, P. H., Goldberg, A. C., Knapp, H. R., Kelly, M. T., Setze, C. M., Stolzenbach, J. C., & Sleep, D. J. (2010). Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. American Heart Journal, 160(4), 759-66. https://doi.org/10.1016/j.ahj.2010.06.045
Jones PH, et al. Efficacy and Safety of Fenofibric Acid in Combination With Atorvastatin and Ezetimibe in Patients With Mixed Dyslipidemia. Am Heart J. 2010;160(4):759-66. PubMed PMID: 20934572.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. AU - Jones,Peter H, AU - Goldberg,Anne C, AU - Knapp,Howard R, AU - Kelly,Maureen T, AU - Setze,Carolyn M, AU - Stolzenbach,James C, AU - Sleep,Darryl J, PY - 2009/09/18/received PY - 2010/06/24/accepted PY - 2010/10/12/entrez PY - 2010/10/12/pubmed PY - 2010/10/29/medline SP - 759 EP - 66 JF - American heart journal JO - Am Heart J VL - 160 IS - 4 N2 - BACKGROUND: Statin and ezetimibe combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. METHODS: In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides ≥150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C ≥130 mg/dL were randomized to 12 weeks of treatment with fenofibric acid 135 mg (FA) or placebo, each coadministered with atorvastatin 40 mg + ezetimibe 10 mg (Atorva/Eze). RESULTS: Both treatment regimens lowered LDL-C by >50%; however, FA + Atorva/Eze resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with Atorva/Eze. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination. CONCLUSIONS: In patients with mixed dyslipidemia, the combination of FA + Atorva/Eze significantly improved lipid and nonlipid parameters compared with Atorva/Eze and was generally well tolerated. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/20934572/Efficacy_and_safety_of_fenofibric_acid_in_combination_with_atorvastatin_and_ezetimibe_in_patients_with_mixed_dyslipidemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(10)00561-2 DB - PRIME DP - Unbound Medicine ER -