title: Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia.
abstract: OBJECTIVE
  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 > or =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 > or =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.
authors.affiliation: National Clinical Research Inc., Richmond, Virginia 23294, USA. jmckenney@ncrinc.net
authors.forename: James M
authors.initials: JM
authors.lastname: McKenney
authors.forename: Michel
authors.initials: M
authors.lastname: Farnier
authors.forename: Kwok-Wing
authors.initials: KW
authors.lastname: Lo
authors.forename: Harold E
authors.initials: HE
authors.lastname: Bays
authors.forename: Inna
authors.initials: I
authors.lastname: Perevozkaya
authors.forename: Gary
authors.initials: G
authors.lastname: Carlson
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Davies
authors.forename: Yale B
authors.initials: YB
authors.lastname: Mitchel
authors.forename: Barry
authors.initials: B
authors.lastname: Gumbiner
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001384:Azetidines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D006950:Hyperlipidemia, Familial Combined / Q000097:blood / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D000960:Hypolipidemic Agents; D008055:Lipids; D000069438:Ezetimibe; D011345:Fenofibrate