Evidence map›Paper›PMID 21993710›Full record

Trial reportDiabetologia2011

Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study.

E Imai, J C N Chan, S Ito, T Yamasaki, F Kobayashi, M Haneda, H Makino, ORIENT study investigators

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00141453 (CS-866DM Phase 3 Clinical Study), which is not on this map. Cited by 87 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 23 pooled it
17.5field-weighted citation impact, top 1% 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.

NCT00141453 phase3completednot on this map

CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2003 to 2009Enrolled577ConditionsDiabetic Nephropathy, Type 2 Diabetes Mellitus, ProteinuriaArmsolmesartan medoxomil, Placebo Tablets
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 23 syntheses or guidelines pooled it, 239 citations in OpenAlex.

  1. Pooled it
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  3. The association between dual RAAS inhibition and risk of acute kidney injury and hyperkalemia in patients with diabetic kidney disease: a systematic review and meta-analysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
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  6. Guideline
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  13. Pharmacotherapy for hypertension in adults 60 years or older.The Cochrane database of systematic reviews · 2019
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  14. Guideline
  15. First-line drugs for hypertension.The Cochrane database of systematic reviews · 2018
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  20. Assessing the Validity of Surrogate Outcomes for ESRD: A Meta-Analysis.Journal of the American Society of Nephrology : JASN · 2015
    Pooled it

27 more citing papers are in PubMed but not listed here.

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

8 authors at 6 institutions in 3 countries.

E ImaiDepartment of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan. ADS12069@nifty.com
J C N Chan
S Ito
T Yamasaki
F Kobayashi
M Haneda
H Makino
ORIENT study investigators
Asahikawa Medical University · JPChinese University of Hong Kong · HKDaiichi-Sankyo (Japan) · JPNagoya University · JPOkayama University · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI).

methodsWe examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.

resultsFive hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [n = 424] received concomitant ACEI), were given either once-daily olmesartan (10-40 mg) (n = 288) or placebo (n = 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24; p = 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%). CONCLUSIONS/

interpretationOlmesartan was well tolerated but did not improve renal outcome on top of ACEI.

trial registrationClinicalTrials.gov NCT00141453.

Indexed as

Angiotensin II Type 1 Receptor BlockersAntihypertensive AgentsAsian PeopleCardiovascular DiseasesCreatinineDiabetes Mellitus, Type 2Diabetic NephropathiesDrug Therapy, CombinationFemaleHumansHyperkalemiaHypertensionImidazolesKidney Failure, ChronicMaleMiddle AgedAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsCreatinineImidazolesolmesartanTetrazoles

Identifiers

PMID21993710
PMCPMC3210358
OpenAlexW2047335781

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.