title: Effects of adding ezetimibe to fluvastatin on kidney function in patients with hypercholesterolemia: a randomized control trial.
abstract: OBJECTIVE
  Statins not only reduce low-density lipoprotein (LDL) cholesterol, but also prevent the progression of kidney dysfunction. Ezetimibe, a cholesterol-absorption inhibitor, also lowers LDL cholesterol levels when added to statins; however, the effect of add-on ezetimibe on kidney function has had conflicting results.
  
  
  METHODS
  We conducted an open-labeled, randomized, 12-month trial, comparing the effects of daily therapy with 20 mg fluvastatin either with or without 10 mg ezetimibe in 54 patients with dyslipidemia. The prespecified primary outcome was the percent change from baseline in kidney function, which was defined by the estimated glomerular filtration rate. The secondary outcomes were the changes in surrogate atherosclerotic markers. All analyses were by intention to treat.
  
  
  RESULTS
  The primary outcome, the percent change from baseline (±SE) of the estimated glomerular filtration rate, was -5.5±1.9% in the fluvastatin-only group and 6.6±1.9% in the fluvastatin-plus-ezetimibe (combined-therapy) group (p=0.0002). Secondary outcomes, consisting of the cardioankle vascular index, augmentation index, ankle-brachial index, and maximum intima-media thickness of the carotid arteries, did not differ significantly between the two groups. At the end of the study, the mean (±SD) LDL cholesterol was 122±23 mg per deciliter in the fluvastatin group and 111±29 mg per deciliter in the combined-therapy group (a between-group difference of 9.2%, p= 0.036). Side-effect and safety profiles were similar in the two groups.
  
  
  CONCLUSIONS
  Combined therapy with fluvastatin 20 mg plus ezetimibe 10 mg daily resulted in a significant improvement in changes in the estimated glomerular filtration rate.
authors.affiliation: Division of Endocrinology, Metabolism, and Nephrology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Kinouchi
authors.forename: Atsuhiro
authors.initials: A
authors.lastname: Ichihara
authors.forename: Kanako
authors.initials: K
authors.lastname: Bokuda
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morimoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Itoh
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001384:Azetidines / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy* / Q000503:physiopathology; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D000077340:Fluvastatin; D000069438:Ezetimibe