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CLINICAL RESEARCH: HYPERLIPIDEMIA AND METABOLIC SYNDROME

Safety and Efficacy of Long-Term Co-Administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia

James M. McKenney, PharmD^_*,_*, Michel Farnier, MD, PhD, Kwok-Wing Lo, MD, Harold E. Bays, MD, Inna Perevozkaya, PhD^¶, Gary Carlson, BS^¶, Michael J. Davies, PhD^¶, Yale B. Mitchel, MD^¶ and Barry Gumbiner, MD^¶

^_* National Clinical Research Inc., Richmond, Virginia
Point Medical, Dijon, France
Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong
Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky
^¶ Merck Research Laboratories, Rahway, New Jersey

Manuscript received August 8, 2005; revised manuscript received October 31, 2005, accepted November 30, 2005.

^_* Reprint requests and correspondence: Dr. James M. McKenney, National Clinical Research Inc., 2809 Emerywood Parkway, Suite 140, Richmond, Virginia 23294 (Email: jmckenney{at}ncrinc.net).

OBJECTIVES: This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia.

BACKGROUND: Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia.

METHODS: After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively.

RESULTS: Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (–22% vs. –9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non–HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase 3 times upper limit of normal were similar between the FENO plus EZE (1.2%) and FENO (1.7%) groups. No cases of creatine phosphokinase elevations 10 times upper limit of normal or myopathy were observed in either group.

CONCLUSIONS: Long-term, 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia.

Abbreviations and Acronyms   AE = adverse experience   ALT = alanine aminotransferase   AST = aspartate aminotransferase   CPK = creatine phosphokinase   EZE = ezetimibe   FENO = fenofibrate   HDL-C = high-density lipoprotein-cholesterol   hs-CRP = high-sensitivity C-reactive protein   LDL-C = low-density lipoprotein-cholesterol   TC = total cholesterol   ULN = upper limit of normal

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