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Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia.
Eur Heart J. 2005 May; 26(9):897-905.EH

Abstract

AIMS

To examine the efficacy and safety of coadministered ezetimibe (EZE) with fenofibrate (FENO) in patients with mixed hyperlipidaemia.

METHODS AND RESULTS

This was a multicentre, randomized, double-blind, placebo-controlled, parallel arm trial in patients with mixed hyperlipidaemia [LDL-cholesterol (LDL-C), 3.4-5.7 mmol/L (2.6-4.7 mmol/L for patients with type 2 diabetes); triglycerides (TG), 2.3-5.7 mmol/L] and no history of coronary heart disease (CHD), CHD-equivalent disease (except for type 2 diabetes), or CHD risk score>20%. A total of 625 patients was randomized in a 1:3:3:3 ratio to one of four daily treatments for 12 weeks: placebo; EZE 10 mg; FENO 160 mg; FENO 160 mg plus EZE 10 mg (FENO+EZE). The primary endpoint compared the LDL-C lowering efficacy of FENO+EZE vs. FENO alone. LDL-C, non-HDL-cholesterol (non-HDL-C), and apolipoprotein B were significantly (P<0.001) reduced with FENO+EZE when compared with FENO or EZE alone. TG levels were significantly decreased and HDL-C was significantly increased with FENO+EZE and FENO treatments when compared with placebo (P<0.001). Coadministration therapy reduced LDL-C by 20.4%, non-HDL-C by 30.4%, TG by 44.0%, and increased HDL-C by 19.0%. At baseline, >70% of all patients exhibited the small, dense LDL pattern B profile. A greater proportion of patients on FENO+EZE and FENO alone treatments shifted from a more atherogenic LDL size pattern to a larger, more buoyant, and less atherogenic LDL size pattern at study endpoint than those on placebo or EZE. All three active therapies were well tolerated.

CONCLUSION

Coadministration of EZE with FENO provided a complementary efficacy therapy that improves the atherogenic lipid profile of patients with mixed hyperlipidaemia.

Authors+Show Affiliations

Point Medical, Rond Point de la Nation, Dijon F-21 000, France. mfarnier@ipac.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15781429

Citation

Farnier, Michel, et al. "Efficacy and Safety of the Coadministration of Ezetimibe With Fenofibrate in Patients With Mixed Hyperlipidaemia." European Heart Journal, vol. 26, no. 9, 2005, pp. 897-905.
Farnier M, Freeman MW, Macdonell G, et al. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J. 2005;26(9):897-905.
Farnier, M., Freeman, M. W., Macdonell, G., Perevozskaya, I., Davies, M. J., Mitchel, Y. B., & Gumbiner, B. (2005). Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. European Heart Journal, 26(9), 897-905.
Farnier M, et al. Efficacy and Safety of the Coadministration of Ezetimibe With Fenofibrate in Patients With Mixed Hyperlipidaemia. Eur Heart J. 2005;26(9):897-905. PubMed PMID: 15781429.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. AU - Farnier,Michel, AU - Freeman,Mason W, AU - Macdonell,Geraldine, AU - Perevozskaya,Inna, AU - Davies,Michael J, AU - Mitchel,Yale B, AU - Gumbiner,Barry, AU - ,, Y1 - 2005/03/21/ PY - 2005/3/23/pubmed PY - 2005/8/27/medline PY - 2005/3/23/entrez SP - 897 EP - 905 JF - European heart journal JO - Eur. Heart J. VL - 26 IS - 9 N2 - AIMS: To examine the efficacy and safety of coadministered ezetimibe (EZE) with fenofibrate (FENO) in patients with mixed hyperlipidaemia. METHODS AND RESULTS: This was a multicentre, randomized, double-blind, placebo-controlled, parallel arm trial in patients with mixed hyperlipidaemia [LDL-cholesterol (LDL-C), 3.4-5.7 mmol/L (2.6-4.7 mmol/L for patients with type 2 diabetes); triglycerides (TG), 2.3-5.7 mmol/L] and no history of coronary heart disease (CHD), CHD-equivalent disease (except for type 2 diabetes), or CHD risk score>20%. A total of 625 patients was randomized in a 1:3:3:3 ratio to one of four daily treatments for 12 weeks: placebo; EZE 10 mg; FENO 160 mg; FENO 160 mg plus EZE 10 mg (FENO+EZE). The primary endpoint compared the LDL-C lowering efficacy of FENO+EZE vs. FENO alone. LDL-C, non-HDL-cholesterol (non-HDL-C), and apolipoprotein B were significantly (P<0.001) reduced with FENO+EZE when compared with FENO or EZE alone. TG levels were significantly decreased and HDL-C was significantly increased with FENO+EZE and FENO treatments when compared with placebo (P<0.001). Coadministration therapy reduced LDL-C by 20.4%, non-HDL-C by 30.4%, TG by 44.0%, and increased HDL-C by 19.0%. At baseline, >70% of all patients exhibited the small, dense LDL pattern B profile. A greater proportion of patients on FENO+EZE and FENO alone treatments shifted from a more atherogenic LDL size pattern to a larger, more buoyant, and less atherogenic LDL size pattern at study endpoint than those on placebo or EZE. All three active therapies were well tolerated. CONCLUSION: Coadministration of EZE with FENO provided a complementary efficacy therapy that improves the atherogenic lipid profile of patients with mixed hyperlipidaemia. SN - 0195-668X UR - https://www.unboundmedicine.com/medline/citation/15781429/Efficacy_and_safety_of_the_coadministration_of_ezetimibe_with_fenofibrate_in_patients_with_mixed_hyperlipidaemia_ L2 - https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehi231 DB - PRIME DP - Unbound Medicine ER -