Evidence map›Paper›PMID 24053480›Full record

Trial reportLipids in health and disease2013

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.

Keiichi Torimoto, Yosuke Okada, Hiroko Mori, Maiko Hajime, Kenichi Tanaka, Akira Kurozumi, Manabu Narisawa, Sunao Yamamoto, Tadashi Arao, Hirofumi Matsuoka and 2 more

Open access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lipids in health and disease, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 51 citations in OpenAlex.

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  4. Ezetimibe in high-risk, previously treated statin patients: a systematic review and network meta-analysis of lipid efficacy.Clinical research in cardiology : official journal of the German Cardiac Society · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Keiichi TorimotoFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushyu-shi 807-8555, Japan. tanaka@med.uoeh-u.ac.jp.
Yosuke Okada
Hiroko Mori
Maiko Hajime
Kenichi Tanaka
Akira Kurozumi
Manabu Narisawa
Sunao Yamamoto
Tadashi Arao
Hirofumi Matsuoka
Nobuo Inokuchi
Yoshiya Tanaka
University of Occupational and Environmental Health Japan · JPOno Clinic · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AgedAnticholesteremic AgentsAzetidinesCholesterol, LDLDiabetes Mellitus, Type 2Drug Administration ScheduleDrug SynergismDrug Therapy, CombinationEzetimibeFemaleFluorobenzenesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaLipoproteins, LDLMaleAnticholesteremic AgentsAzetidinesCholesterol, LDLEzetimibeFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsLipoproteins, LDLoxidized low density lipoproteinPyrimidinesRosuvastatin CalciumSulfonamidesTriglycerides

Identifiers

PMID24053480
PMCPMC3849617
OpenAlexW2149237513

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.