Evidence mapPaperPMID 30393955Full record

Trial reportDiabetes, obesity & metabolism2019

Achieving LDL cholesterol target levels <1.81 mmol/L may provide extra cardiovascular protection in patients at high risk: Exploratory analysis of the Standard Versus Intensive Statin Therapy for Patients with Hypercholesterolaemia and Diabetic Retinopathy study.

Hiroshi Itoh, Issei Komuro, Masahiro Takeuchi, Takashi Akasaka, Hiroyuki Daida, Yoshiki Egashira, Hideo Fujita, Jitsuo Higaki, Ken-Ichi Hirata, Shun Ishibashi and 33 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Nutrients · 2019
    Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Observational
  9. Article
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

43 authors at 20 institutions in 1 country.

Hiroshi ItohDepartment of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine, Tokyo, Japan.ORCID 0000-0003-2514-4919
Issei KomuroDepartment of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Masahiro TakeuchiDepartment of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan.
Takashi AkasakaDepartment of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.
Hiroyuki DaidaDepartment of Cardiovascular Medicine, Graduate School of Medicine Juntendo University, Tokyo, Japan.
Yoshiki EgashiraSakura Hospital, Fukuoka, Japan.
Hideo FujitaDepartment of Cardiology, Saitama Medical Centre, Jichi Medical University, Saitama, Japan.
Jitsuo HigakiDepartment of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine, Toon, Japan.
Ken-Ichi HirataDivision of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
Shun IshibashiDivision of Endocrinology and Metabolism, Department of Internal Medicine, Jichi Medical University, Shimotsuke, Japan.
Takaaki IsshikiDivision of Cardiology, Cardiovascular Centre, Ageo Central General Hospital, Ageo, Japan.
Sadayoshi ItoDivision of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Atsunori KashiwagiKusatsu General Hospital, Kusatsu, Japan.
Satoshi KatoDepartment of Ophthalmology, University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Kazuo KitagawaDepartment of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Masafumi KitakazeDivision of Cardiology, National Cerebral and Cardiovascular Centre, Suita, Japan.
Takanari KitazonoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Masahiko KurabayashiDepartment of Medicine and Biological Science, Gunma University Graduate School of Medicine, Maebashi, Japan.
Katsumi MiyauchiDepartment of Cardiology, Graduate School of Medicine Juntendo University, Tokyo, Japan.
Tomoaki MurakamiDepartment of Ophthalmology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Toyoaki MuroharaDepartment of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Koichi NodeDepartment of Cardiovascular Medicine, Saga University, Saga, Japan.ORCID 0000-0002-2534-0939
Susumu OgawaDivision of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Hospital, Sendai, Japan.ORCID 0000-0001-5489-9259
Yoshihiko SaitoFirst Department of Internal Medicine, Nara Medical University, Kashihara, Japan.
Yoshihiko SeinoDepartment of Cardiology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.
Takashi ShigeedaIdeta Eye Clinic, Kumamoto, Japan.
Shunya ShindoDepartment of Cardiovascular Surgery, Tokyo Medical University Hachioji Medical Centre, Hachioji, Japan.
Masahiro SugawaraSugawara Medical Clinic, Tokyo, Japan.
Seigo SugiyamaDepartment of Cardiology, Jinnouchi Hospital, Kumamoto, Japan.
Yasuo TerauchiDepartment of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Japan.ORCID 0000-0002-8872-3697
Hiroyuki TsutsuiDepartment of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kenji UeshimaDepartment of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Kazunori UtsunomiyaDivision of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Masakazu YamagishiDepartment of Cardiovascular and Internal Medicine, Kanazawa University Graduate School of Medicine, Kanazawa, Japan.
Tsutomu YamazakiClinical Research Support Centre, University of Tokyo Hospital, Tokyo, Japan.
Shoei YoYo Clinic, Kyoto, Japan.
Koutaro YokoteDepartment of Clinical Cell Biology and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Kiyoshi YoshidaSakakibara Heart Institute of Okayama, Okayama, Japan.
Michihiro YoshimuraDivision of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Nagahisa YoshimuraKitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.
Kazuwa NakaoMedical Innovation Centre, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Ryozo NagaiJichi Medical University, Shimotsuke, Japan.
EMPATHY Investigators
Jichi Medical University · JPJikei University School of Medicine · JPJuntendo University · JPKyoto University · JPKyushu University · JPChiba Hokusou Hospital · JPChiba University · JPEhime University · JPEiju General Hospital · JPFukuoka Hospital · JPGunma University · JPHakodate Central General Hospital · JPIdeta Eye Hospital · JPJapan Graduate School of Education University · JPKanazawa University · JPKeio University · JPKitano Hospital · JPKitasato University · JPKobe University · JPKumamoto Orthopedic Surgery Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the benefits of intensive statin therapy on reducing cardiovascular (CV) events in patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan. In the intension-to-treat population, intensive therapy [targeting LDL cholesterol <1.81 mmol/L (<70 mg/dL)] was no more effective than standard therapy [LDL cholesterol ≥2.59 to <3.10 mmol/L (≥100 to <120 mg/dL)]; however, after 3 years, the intergroup difference in LDL cholesterol was only 0.72 mmol/L (27.7 mg/dL), and targeted levels were achieved in <50% of patients. We hypothesized that the intergroup difference in CV events would have been statistically significant if more patients had been successfully treated to target. MATERIALS AND

methodsThis exploratory post hoc analysis focused on intergroup data from patients who achieved their target LDL cholesterol levels. The primary endpoint was the composite incidence of CV events. A Cox proportional hazards model was used to estimate hazard ratios (HRs) for incidence of the primary endpoint in patients who achieved target LDL cholesterol levels in each group.

resultsData were analysed from 1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels. LDL cholesterol at 36 months was 1.54 ± 0.30 mmol/L (59.7 ± 11.6 mg/dL) in the intensive group and 2.77 ± 0.46 mmol/L (107.1 ± 17.8 mg/dL) in the standard group (P < 0.05). After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007).

conclusionsThis post hoc analysis suggests that achieving LDL cholesterol target levels <1.81 mmol/L may more effectively reduce CV events than achieving target levels ≥2.59 to <3.10 mmol/L in patients with hypercholesterolaemia and diabetic retinopathy.

Indexed as

AgedCardiovascular DiseasesCholesterol, LDLDiabetes Mellitus, Type 2Diabetic RetinopathyFemaleGlycated HemoglobinHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHyperlipidemiasIntention to Treat AnalysisJapanMaleMiddle AgedPatient Care PlanningPrimary PreventionCholesterol, LDLGlycated Hemoglobinhemoglobin A1c protein, humanHydroxymethylglutaryl-CoA Reductase Inhibitorscardiovascular diseaseclinical trialdiabetic retinopathydyslipidaemialipid-lowering therapy

Identifiers

PMID30393955
PMCPMC6587486
OpenAlexW2899578298

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.