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Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia.
Am Heart J 2007; 153(2):335.e1-8AH

Abstract

BACKGROUND

Mixed hyperlipidemia is characterized by elevated low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and TG-rich lipoprotein levels.

METHODS

In a multicenter, randomized, double-blind, placebo-controlled, parallel arm trial, eligible patients were 18 to 79 years of age, with mixed hyperlipidemia (LDL-C 130-220 mg/dL, TG 150-500 mg/dL). Patients with type 2 diabetes were limited to those with LDL-C of 100 to 180 mg/dL. Patients (N = 611) were randomized in a 3:3:3:1 ratio to one of 4 treatment arms for 12 weeks: ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) + fenofibrate 160 mg (FENO), EZE/SIMVA 10/20 mg, FENO 160 mg, or placebo. The primary objective was to evaluate the LDL-C-lowering efficacy of EZE/SIMVA + FENO versus FENO monotherapy.

RESULTS

Low-density lipoprotein cholesterol level was significantly (P < .05) reduced with EZE/SIMVA + FENO (-45.8%) compared with FENO (-15.7%) or placebo (-3.5%), but not when compared with EZE/SIMVA (-47.1%). High-density lipoprotein cholesterol and apolipoprotein A-I levels were significantly increased with EZE/SIMVA + FENO (18.7% and 11.1%, respectively) treatment compared with EZE/SIMVA (9.3% and 6.6%) or placebo (1.1% and 1.6%), but not when compared with FENO (18.2% and 10.8%). Triglyceride, non-high-density lipoprotein cholesterol, and apolipoprotein B levels were significantly reduced with EZE/SIMVA + FENO (-50.0%, -50.5%, and -44.7%, respectively) versus all other treatments. Treatment with EZE/SIMVA + FENO was generally well tolerated with a safety profile similar to the EZE/SIMVA and FENO therapies.

CONCLUSIONS

Coadministration of EZE/SIMVA + FENO effectively improved the overall atherogenic lipid profile of patients with mixed hyperlipidemia. Clinical trial registry number: NCT 00093899 (http://www.ClinicalTrials.gov).

Authors+Show Affiliations

Point Medical, Dijon, France. michelfarnier@nerim.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

17239698

Citation

Farnier, Michel, et al. "Efficacy and Safety of the Coadministration of Ezetimibe/simvastatin With Fenofibrate in Patients With Mixed Hyperlipidemia." American Heart Journal, vol. 153, no. 2, 2007, pp. 335.e1-8.
Farnier M, Roth E, Gil-Extremera B, et al. Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. Am Heart J. 2007;153(2):335.e1-8.
Farnier, M., Roth, E., Gil-Extremera, B., Mendez, G. F., Macdonell, G., Hamlin, C., ... Mitchel, Y. B. (2007). Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. American Heart Journal, 153(2), pp. 335.e1-8.
Farnier M, et al. Efficacy and Safety of the Coadministration of Ezetimibe/simvastatin With Fenofibrate in Patients With Mixed Hyperlipidemia. Am Heart J. 2007;153(2):335.e1-8. PubMed PMID: 17239698.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of the coadministration of ezetimibe/simvastatin with fenofibrate in patients with mixed hyperlipidemia. AU - Farnier,Michel, AU - Roth,Eli, AU - Gil-Extremera,Blas, AU - Mendez,Gustavo F, AU - Macdonell,Geraldine, AU - Hamlin,Constance, AU - Perevozskaya,Inna, AU - Davies,Michael J, AU - Kush,Debra, AU - Mitchel,Yale B, AU - ,, PY - 2006/05/08/received PY - 2006/10/28/accepted PY - 2007/1/24/pubmed PY - 2007/3/21/medline PY - 2007/1/24/entrez SP - 335.e1 EP - 8 JF - American heart journal JO - Am. Heart J. VL - 153 IS - 2 N2 - BACKGROUND: Mixed hyperlipidemia is characterized by elevated low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and TG-rich lipoprotein levels. METHODS: In a multicenter, randomized, double-blind, placebo-controlled, parallel arm trial, eligible patients were 18 to 79 years of age, with mixed hyperlipidemia (LDL-C 130-220 mg/dL, TG 150-500 mg/dL). Patients with type 2 diabetes were limited to those with LDL-C of 100 to 180 mg/dL. Patients (N = 611) were randomized in a 3:3:3:1 ratio to one of 4 treatment arms for 12 weeks: ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) + fenofibrate 160 mg (FENO), EZE/SIMVA 10/20 mg, FENO 160 mg, or placebo. The primary objective was to evaluate the LDL-C-lowering efficacy of EZE/SIMVA + FENO versus FENO monotherapy. RESULTS: Low-density lipoprotein cholesterol level was significantly (P < .05) reduced with EZE/SIMVA + FENO (-45.8%) compared with FENO (-15.7%) or placebo (-3.5%), but not when compared with EZE/SIMVA (-47.1%). High-density lipoprotein cholesterol and apolipoprotein A-I levels were significantly increased with EZE/SIMVA + FENO (18.7% and 11.1%, respectively) treatment compared with EZE/SIMVA (9.3% and 6.6%) or placebo (1.1% and 1.6%), but not when compared with FENO (18.2% and 10.8%). Triglyceride, non-high-density lipoprotein cholesterol, and apolipoprotein B levels were significantly reduced with EZE/SIMVA + FENO (-50.0%, -50.5%, and -44.7%, respectively) versus all other treatments. Treatment with EZE/SIMVA + FENO was generally well tolerated with a safety profile similar to the EZE/SIMVA and FENO therapies. CONCLUSIONS: Coadministration of EZE/SIMVA + FENO effectively improved the overall atherogenic lipid profile of patients with mixed hyperlipidemia. Clinical trial registry number: NCT 00093899 (http://www.ClinicalTrials.gov). SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/17239698/Efficacy_and_safety_of_the_coadministration_of_ezetimibe/simvastatin_with_fenofibrate_in_patients_with_mixed_hyperlipidemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(06)00970-7 DB - PRIME DP - Unbound Medicine ER -