Efficacy of combination of Ezetimibe 10 mg and rosuvastatin 2.5 mg versus rosuvastatin 5 mg monotherapy for hypercholesterolemia in patients with type 2 diabetesReport as inadecuate




Efficacy of combination of Ezetimibe 10 mg and rosuvastatin 2.5 mg versus rosuvastatin 5 mg monotherapy for hypercholesterolemia in patients with type 2 diabetes - Download this document for free, or read online. Document in PDF available to download.

Lipids in Health and Disease

, 12:137

First Online: 22 September 2013Received: 30 July 2013Accepted: 18 September 2013

Abstract

BackgroundStatins are used to treat hypercholesterolemia in patients with type 2 diabetes mellitus, but many of these patients fail to achieve the target LDL-C level. Recent reports have suggested that a synergistic effect can be obtained by concomitant administration of the cholesterol absorption inhibitor ezetimibe and a statin. However, in patients with type 2 diabetes who are already being treated with satins, it remains unclear whether it is more effective to add ezetimibe or to increase the statin dose. Therefore, this study was performed to examine the effects of these two regimens on LDL-C and lipoproteins.

MethodsThe subjects were type 2 diabetic patients under treatment with rosuvastatin 2.5 mg daily, who had LDL-C levels ≥80 mg-dL. They were randomly allocated to a group that received add-on therapy with ezetimibe at 10 mg-day combination group, n = 40 or an increase of the rosuvastatin dose to 5 mg-day dose escalation group, n = 39. These two groups were compared at baseline and after 12 weeks of treatment.

ResultsThe percent change of LDL-C was −31% in the combination group and −12% in the dose escalation group. Both groups showed a significant decrease, but the decrease was greater in the combination group. In both groups, there was a significant decrease in the levels of small dense LDL-C, oxidized LDL and remnant-like lipoprotein cholesterol. For all of these parameters, the percent changes were greater in the combination group. Only the combination group showed a significant decrease of triglycerides. Multivariate analysis was performed to identify factors associated with reaching an LDL-C level <80 mg-dL. As a result, add-on therapy with ezetimibe was extracted as a factor related to improvement of LDL-C.

ConclusionsCompared with increasing the dose of rosuvastatin, the combination of rosuvastatin and ezetimibe not only achieves quantitative but also qualitative improvement of serum lipid levels in type 2 diabetic patients, suggesting that this combination could suppress the progression of atherosclerosis.

Trial registrationUMIN000011005

KeywordsRosuvastatin Ezetimibe Hypercholesterolemia Type 2 diabetes mellitus AbbreviationsLDL-CLow-density lipoprotein cholesterol

HDL-CHigh-density lipoprotein cholesterol

JDCSJapan diabetes complications study

TGTriglycerides

sdLDL-CSmall dense low-density lipoprotein cholesterol

oxidized LDLOxidized low-density lipoprotein cholesterol

NPC1L1Ezetimibe inhibits niemann-pick C1-like protein 1

NGSPNational glycohemoglobin standardization program

MDA-LDLMalondialdehyde-modified low-density lipoprotein

RLP-CRemnant-like particle cholesterol

HOMA-IRInsulin resistance index

JDSJapanese standard substance

NCEP ATP IIINational cholesterol education program adult treatment panel III

MetSynMetabolic syndrome

ABCATP-binding cassette transporters.

Electronic supplementary materialThe online version of this article doi:10.1186-1476-511X-12-137 contains supplementary material, which is available to authorized users.

Keiichi Torimoto, Yosuke Okada, Hiroko Mori, Maiko Hajime, Kenichi Tanaka, Akira Kurozumi, Manabu Narisawa, Sunao Yamamoto, Tadashi Arao, Hirofumi Matsuoka, Nobuo Inokuchi contributed equally to this work.

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Author: Keiichi Torimoto - Yosuke Okada - Hiroko Mori - Maiko Hajime - Kenichi Tanaka - Akira Kurozumi - Manabu Narisawa - Sunao Y

Source: https://link.springer.com/







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