title: Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy.
abstract: OBJECTIVE
  To assess the long-term safety and efficacy of a fenofibrate/pravastatin 160/40 mg fixed-dose combination in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy.
  
  
  METHODS
  After an 8-week pravastatin 40 mg and diet run-in period, high-risk patients (n = 248) with low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and triglycerides (TG) ≥ 150 and ≤400 mg/dL, were randomized to fenofibrate/pravastatin combination therapy or to pravastatin monotherapy for 12 weeks, followed by an open-label, 52-week safety phase on the combination therapy.
  
  
  RESULTS
  Of the 224 patients who continued after the double-blind phase, 211 completed the one-year safety period. Overall, fenofibrate/pravastatin combination therapy was well tolerated during this extension study. Only three patients had an elevation of ALAT > 3 times the upper limit of normal and one patient a CPK elevation ≥5, but <10 times the upper limit of normal. At week 64, and by comparison to baseline levels on pravastatin 40 mg, the fenofibrate/pravastatin combination therapy significantly reduced non-high-density lipoprotein (non-HDL) cholesterol by 16.3%, LDL-C by 12.2%, TG by 31.6%, apolipoprotein B by 11.0% and increased HDL-cholesterol and apolipoprotein A1 respectively by 4.8 and 9.6% (p < 0.0001 for all the variables). A limitation of this trial is that the study was not powered to assess clinical events.
  
  
  CONCLUSIONS
  Long-term co-administration of fenofibrate/pravastatin 160/40 mg in a single capsule was well tolerated and produced complementary benefits on the overall lipid profile of high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg.
authors.affiliation: Point Medical, Dijon, France. michelfarnier@nerim.net
authors.forename: Michel
authors.initials: M
authors.lastname: Farnier
authors.forename: Jean
authors.initials: J
authors.lastname: Ducobu
authors.forename: Leszek
authors.initials: L
authors.lastname: Bryniarski
mesh_terms: D000368:Aged; D016632:Apolipoprotein A-I / Q000097:blood; D001055:Apolipoproteins B / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000627:therapeutic use*; D012307:Risk Factors; D014280:Triglycerides / Q000097:blood
chemical_list: D016632:Apolipoprotein A-I; D001055:Apolipoproteins B; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D014280:Triglycerides; D017035:Pravastatin; D011345:Fenofibrate