Evidence map›Paper›PMID 28646901›Full record

Trial reportLipids in health and disease2017

Effect of ezetimibe add-on therapy over 52 weeks extension analysis of prospective randomized trial (RESEARCH study) in type 2 diabetes subjects.

Kentaro Sakamoto, Mitsunobu Kawamura, Takayuki Watanabe, Keiko Ashidate, Takahide Kohro, Akira Tanaka, Yasumichi Mori, Motoki Tagami, Tsutomu Hirano, Tsutomu Yamazaki and 2 more

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

Trial report in Lipids in health and disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
2.2field-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

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Ezetimibe for the prevention of cardiovascular disease and all-cause mortality events.The Cochrane database of systematic reviews · 2018 · on this map
    Pooled it
  4. Article
  5. Article
  6. Review
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 10 institutions in 1 country.

Kentaro SakamotoDepartment of Diabetes and Metabolism, Toho University Ohashi Medical Center, 2-17-6, Ohashi, Meguro-ku, Tokyo, 1538515, Japan.
Mitsunobu KawamuraDivision of Endocrinology and Metabolism Department of Internal Medicine, Tokyo Teishin Hospital, Tokyo, Japan.
Takayuki WatanabeDepartment of Internal Medicine, Yokohama City Minato Red Cross Hospital, Tokyo, Kanagawa, Japan.
Keiko AshidateDepartment of Internal Medicine, Kudanzaka Hospital, Tokyo, Japan.
Takahide KohroDepartment of Medical Informatics / Cardiology, Jichi Medical University, Tochigi, Japan.
Akira TanakaNutrition Clinic, Kagawa Nutrition University, Tokyo, Japan.
Yasumichi MoriDepartment of Endocrinology and Metabolism, Toranomon Hospital, Tokyo, Japan.
Motoki TagamiSanraku Hospital, Life-style related Disease Clinic, Tokyo, Japan.
Tsutomu HiranoDepartment of Medicine Division of Diabetes Metabolism and Endocrinology, Showa University School of Medicine, Tokyo, Japan.
Tsutomu YamazakiClinical Research Support Center, The University of Tokyo Hospital, Tokyo, Japan.
Teruo ShibaDepartment of Diabetes and Metabolism, Toho University Ohashi Medical Center, 2-17-6, Ohashi, Meguro-ku, Tokyo, 1538515, Japan. teruo.shiba@med.toho-u.ac.jp.
RESEARCH Study Group
Jichi Medical University · JPKagawa Nutrition University · JPKudanzaka Hospital · JPSanraku Hospital · JPShowa University · JPToho University · JPTokyo Teishin Hospital · JPToranomon Hospital · JPUniversity of Tokyo Hospital · JPYokohama Municipal Minato Red Cross Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLowering cholesterol levels decreases the risk of atherosclerotic diseases. Effective ways to stably reduce LDL-C level are warranted in type 2 diabetic patients, a high-risk population for CVD, with various anti-diabetic therapeutic background. The RESEARCH study focuses on LDL-C reduction in this population along with modifications of the lipid profiles. We evaluated long-term ezetimibe add-on therapy in T2DM patients with hypercholesterolemia.

methodsIn a randomized, multicenter, open-label, prospective study, a total of 109 T2DM patients not attaining LDL-C target value despite first-line dose statin (10 mg of atorvastatin or 1 mg of pitavastatin) therapy in Japan were recruited. We investigated the difference in cholesterol lowering effect between ezetimibe (10 mg) add-on statin (EAT) group and double-dose statin (DST) group. Changes of parameters related to atherosclerotic event risks were assessed.

resultsThe reduction of LDL-C was larger in the EAT group (28.3%) than in the DST group (9.2%) at 52 weeks as well as the primary endpoint of 12 weeks. EAT achieved significant lower levels of TC and apo B, respectively. Both treatments attained significant reduction in sd-LDL-C or hsCRP on this long-term basis. Notably, sd-LDL-C in EAT reduced as low as 36.1 ± 14.9 mg/dl to reach near the threshold (35.0 mg/dl) for atherosclerosis with significantly higher achievement rate (55.6%) than DST treatment. Simultaneously, hsCRP reduction by EAT attained as low value as 0.52 ± 0.43 mg/l.

conclusionsIn the present 52-week long-term period, ezetimibe add-on therapy showed a robust advantage in lowering LDL-C and in attaining target LDL-C values compared with the doubling of statin dose. Moreover, it's meaningful that sd-LDL, powerfully atherogenic lipoprotein, exhibited prominent decrease consistently prominently by ezetimibe add-on therapy. DM patients with hypercholesterolemia are at high risk for CAD, and adding ezetimibe onto usual-dose statin treatment in Japan has been suggested as the first-line therapy for those DM patients who failed to attain the target LDL-C value (UMIN000002593).

Indexed as

Anticholesteremic AgentsCholesterol, LDLDiabetes Mellitus, Type 2Double-Blind MethodEzetimibeFemaleHumansMaleProspective StudiesAnticholesteremic AgentsCholesterol, LDLEzetimibe

Identifiers

PMID28646901
PMCPMC5483302
OpenAlexW2636265553

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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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.