European Heart Journal Advance Access originally published online on March 21, 2005
European Heart Journal 2005 26(9):897-905; doi:10.1093/eurheartj/ehi231
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Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia
1Point Medical, Rond Point de la Nation, Dijon F-21 000, France
2Massachusetts General Hospital, Boston, MA, USA
3Merck Research Laboratory, Rahway, NJ, USA
Received 26 October 2004; revised 9 February 2005; accepted 17 February 2005; online publish-ahead-of-print 21 March 2005.
* Corresponding author. Tel: +33 380 703 813; fax: +33 380 703 894. E-mail address: mfarnier{at}ipac.fr
See page 856 for the editorial comment on this article (doi:10.1093/eurheartj/ehi215)
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.
Key Words: Cholesterol absorption inhibition • Ezetimibe • Fenofibrate • Lipoproteins • LDL particle size
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