Effects of adding ezetimibe to fluvastatin on kidney function in patients with hypercholesterolemia: A randomized control trial

Kenichiro Kinouchi, Atsuhiro Ichihara, Kanako Bokuda, Satoshi Morimoto, Hiroshi Itoh

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Aims: 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-plusezetimibe (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. Conclusion: Combined therapy with fluvastatin 20 mg plus ezetimibe 10 mg daily resulted in a significant improvement in changes in the estimated glomerular filtration rate.

Original languageEnglish
Pages (from-to)245-256
Number of pages12
JournalJournal of Atherosclerosis and Thrombosis
Volume20
Issue number3
DOIs
Publication statusPublished - 2013 Mar 22

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fluvastatin
Hypercholesterolemia
Kidney
Glomerular Filtration Rate
LDL Cholesterol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Group Psychotherapy
Anticholesteremic Agents
Ankle Brachial Index
Intention to Treat Analysis
Dyslipidemias
Carotid Arteries
Blood Vessels
Biomarkers
Ezetimibe
Safety

Keywords

  • Arterial stiffness
  • Ezetimibe
  • Kidney function

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Internal Medicine
  • Biochemistry, medical

Cite this

Effects of adding ezetimibe to fluvastatin on kidney function in patients with hypercholesterolemia : A randomized control trial. / Kinouchi, Kenichiro; Ichihara, Atsuhiro; Bokuda, Kanako; Morimoto, Satoshi; Itoh, Hiroshi.

In: Journal of Atherosclerosis and Thrombosis, Vol. 20, No. 3, 22.03.2013, p. 245-256.

Research output: Contribution to journalArticle

Kinouchi, Kenichiro ; Ichihara, Atsuhiro ; Bokuda, Kanako ; Morimoto, Satoshi ; Itoh, Hiroshi. / Effects of adding ezetimibe to fluvastatin on kidney function in patients with hypercholesterolemia : A randomized control trial. In: Journal of Atherosclerosis and Thrombosis. 2013 ; Vol. 20, No. 3. pp. 245-256.
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AU - Kinouchi, Kenichiro

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AB - Aims: 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-plusezetimibe (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. Conclusion: Combined therapy with fluvastatin 20 mg plus ezetimibe 10 mg daily resulted in a significant improvement in changes in the estimated glomerular filtration rate.

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