Trial reportLipids in health and disease2015

A pilot study of ezetimibe vs. atorvastatin for improving peripheral microvascular endothelial function in stable patients with type 2 diabetes mellitus.

Seigo Sugiyama, Hideaki Jinnouchi, Kunio Hieshima, Noboru Kurinami, Tomoko Suzuki, Fumio Miyamoto, Keizo Kajiwara, Kunihiko Matsui, Tomio Jinnouchi

Open access · goldFull text readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2015. The graph read 2 numbers from its abstract, feeding 2 cells of the map, but none could be read as for or against, so it casts no vote. It also reports an association that does not count as treatment evidence, such as OR 6.42 (1.13 to 36.5) for lipids. Cited by 4 papers.

2numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

Read, but not usablea number the graph found but could not read as for or against

Lipidsan association or prognostic statement, not a treatment comparison · dyslipidemia, t2dfeeds one cell of the map
OR 6.421.13 to 36.5p = 0.036
Forced inclusion multivariate logistic regression analysis with age, gender, and the cholesterol-lowering therapy allocation revealed that ezetimibe therapy significantly correlated with improvements in endothelial function (Table 3, odds ratio: 6.42, 95% confidence interval: 1.13-36.47, p = 0.036).
Cardiac & vascular functioncomparator not stated · dyslipidemia, t2dfeeds one cell of the map
OR 4.881.01 to 23.6p = 0.049
Univariate logistic regression analysis for various clinical factors demonstrated that only ezetimibe therapy significantly correlated with improvements in peripheral microvascular endothelial function defined as the highest tertile of the percent changes in LnRHI (Table 3, odds ratio: 4.88, 95% confidence interval: 1.01-23.57, p = 0.049).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Other lipid agents×lipids

No readable resultOpen on the map →What to test next →

28 readable studies in this cell: 16 favour the treatment, 3 find no difference, 9 favour the comparator.

Belief with this paper
0.50contested · 15 families support, 6 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT004793881,216 enrolled · 2007
Δ -4.50-7.70 to -1.30
NCT00862251808 enrolled · 2009
Percent change in least-square means -14.8-19.6 to -9.91
NCT00485758796 enrolled · 2007
Δ -17.9-21.4 to -14.4
NCT00730132712 enrolled · 2008
Δ -5.75-9.43 to -2.07
NCT01763827615 enrolled · 2013
Δ -39.3-43.3 to -35.3
NCT01984424511 enrolled · 2013
Δ -37.8-42.3 to -33.3
NCT06005597407 enrolled · 2024
Least Squares (LS) Means -27.9-37.5 to -18.4
NCT03337308382 enrolled · 2017
Δ -38.0-46.5 to -29.6
NCT02227784366 enrolled · 2014
Δ -6.14-12.2 to -0.22
NCT01763905307 enrolled · 2013
Δ -38.1-43.7 to -33.0
NCT03001076269 enrolled · 2016
Δ -28.4-34.4 to -22.5

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Other lipid agents×cardiac & vascular function

No readable resultOpen on the map →What to test next →

4 readable studies in this cell: 0 favour the treatment, 4 find no difference, 0 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 3 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT00616772682 enrolled · 2008
Δ -0.01-0.02 to 0.00
NCT00804843100 enrolled · 2009
Δ 0.27-0.24 to 0.78
NCT00817843100 enrolled · 2009
Δ -0.09

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

5 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

9 authors at 2 institutions in 2 countries.

Seigo SugiyamaDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. ssugiyam@kumamoto-u.ac.jp.
Hideaki JinnouchiDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. hideaki@jinnouchi.or.jp.
Kunio HieshimaDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. hieshima@jinnouchi.or.jp.
Noboru KurinamiDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. kurinami@jinnouchi.or.jp.
Tomoko SuzukiDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. t-suzu@jinnouchi.or.jp.
Fumio MiyamotoDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. hisyo@jinnouchi.or.jp.
Keizo KajiwaraDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. dm-net@jinnouchi.or.jp.
Kunihiko MatsuiDepartment of Community Medicine, Kumamoto University Hospital, 1-1-1 Honjo, Chuo-ku, Kumamoto, 862-8556, Japan. kmatsui@kumamoto-u.ac.jp.
Tomio JinnouchiDiabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan. tomio@jinnouchi.or.jp.
Diabetes Care Center · USKumamoto University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundElevated cholesterol in type 2 diabetes mellitus (DM) can cause endothelial dysfunction. An effective clinical therapy to improve endothelial dysfunction remains to be established. Different cardiovascular actions between treatments for the inhibition of cholesterol absorption and the suppression of cholesterol synthesis for achieving improvement in endothelial function are unknown in DM.

methodsStable patients with type 2 DM and mildly elevated low-density lipoprotein cholesterol were enrolled. We evaluated peripheral microvascular endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) examination and calculated a natural logarithmic transformed value for the RH-PAT index (LnRHI). We randomly assigned 33 patients to each monotherapy: cholesterol synthesis suppression using atorvastatin (5 mg/day, n=16) or cholesterol absorption inhibition using ezetimibe (10 mg/day, n=17). Patients were prospectively followed for 6 months. Serum lipids and LnRHI were repeatedly examined before and after each therapy.

resultsLDL significantly decreased in both groups, but the percent changes of LDL showed a greater decrease in the atorvastatin group compared with the ezetimibe group (-34.5±7.8% vs. -21.9±9.6%, p<0.01). Serum levels of non-esterified free fatty acids (NEFA) significantly decreased in the ezetimibe group but not in the atorvastatin group (ezetimibe group: 561.1±236.8 to 429.7±195.9, p<0.01; atorvastatin group: 538.8±319.5 to 520.2±227.3, p=0.75). The percent decrease in NEFA was significantly greater in the ezetimibe group compared with the atorvastatin group (-19.9±27.4% vs. 11.3±44.1%, p<0.05). LnRHI showed a significant increase in the ezetimibe group but not in the atorvastatin group (ezetimibe group: 0.471±0.157 to 0.678±0.187, p<0.01; atorvastatin group: 0.552±0.084 to 0.558±0.202, p=0.64). The percent changes in LnRHI were significantly greater in the ezetimibe group compared with the atorvastatin group (63.3±89.2% vs. 7.4±41.2%, p<0.05).

conclusionsIn patients with type 2 DM, ezetimibe monotherapy significantly reduced LDL and NEFA, and improved peripheral microvascular endothelial dysfunction. Ezetimibe could potentially exhibit beneficial effects on lipid disorders and microvascular endothelial dysfunction in DM.

Indexed as

AgedAnticholesteremic AgentsAtorvastatinBlood GlucoseCholesterolCholesterol, HDLCholesterol, LDLDiabetes Mellitus, Type 2Endothelium, VascularEzetimibeFatty Acids, NonesterifiedFemaleGlycated HemoglobinHumansMaleMiddle AgedAnticholesteremic AgentsAtorvastatinBlood GlucoseCholesterolCholesterol, HDLCholesterol, LDLEzetimibeFatty Acids, NonesterifiedGlycated Hemoglobinhemoglobin A1c protein, humanTriglycerides

Identifiers

PMID25903215
PMCPMC4417230
OpenAlexW1994648242

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LicenceCC BY
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Registered trials

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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.