Evidence map›Paper›PMID 14960504›Full record

Trial reportBMJ (Clinical research ed.)2004

Effects of low dose ramipril on cardiovascular and renal outcomes in patients with type 2 diabetes and raised excretion of urinary albumin: randomised, double blind, placebo controlled trial (the DIABHYCAR study).

Michel Marre, Michel Lievre, Gilles Chatellier, Johannes F E Mann, Philippe Passa, Joël Ménard, DIABHYCAR Study Investigators

Erratum issuedOpen access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 73 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 26 pooled it
14.2field-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.

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

73 citing papers in PubMed, 26 syntheses or guidelines pooled it, 291 citations in OpenAlex.

  1. Pharmacotherapy for mild hypertension.The Cochrane database of systematic reviews · 2025
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  6. Addressing Regional Differences in Diabetes Progression: Global Calibration for Diabetes Simulation Model.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2019
    Pooled it
  7. Pharmacotherapy for hypertension in adults 60 years or older.The Cochrane database of systematic reviews · 2019
    Pooled it
  8. First-line drugs for hypertension.The Cochrane database of systematic reviews · 2018
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  14. Assessing the Validity of Surrogate Outcomes for ESRD: A Meta-Analysis.Journal of the American Society of Nephrology : JASN · 2015
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  20. Early change in proteinuria as a surrogate outcome in kidney disease progression: a systematic review of previous analyses and creation of a patient-level pooled dataset.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2011
    Pooled it

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Michel MarreEndocrinologie-Diabétologie-Nutrition, Groupe Hospitalier Bichat-Claude Bernard, Assistance Publique des Hôpitaux de Paris, 46 rue Henri Huchard, 75877 Paris Cedex 18, France. michel.marre@bch.ap-hop-paris.fr
Michel Lievre
Gilles Chatellier
Johannes F E Mann
Philippe Passa
Joël Ménard
DIABHYCAR Study Investigators
Hôpital Saint-Louis · FRMünchen Klinik Schwabing · DEUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether a low dose of the angiotensin converting enzyme (ACE) inhibitor ramipril lowers cardiovascular and renal events in patients with type 2 diabetes who have microalbuminuria or proteinuria.

designRandomised, double blind, parallel group trial comparing ramipril (1.25 mg/day) with placebo (on top of usual treatment) for cardiovascular and renal outcomes for at least three years.

settingMulticentre, primary care study conducted mostly by general practitioners in 16 European and north African countries.

participants4912 patients with type 2 diabetes aged >50 years who use oral antidiabetic drugs and have persistent microalbuminuria or proteinuria (urinary albumin excretion > or = 20 mg/l in two consecutive samples), and serum creatinine < or = 150 micromol/l.

main outcome measuresThe primary outcome measure was the combined incidence of cardiovascular death, non-fatal myocardial infarction, stroke, heart failure leading to hospital admission, and end stage renal failure.

resultsParticipants were followed for 3 to 6 (median 4) years. There were 362 primary events among the 2443 participants taking ramipril (37.8 per 1000 patient years) and 377 events among the 2469 participants taking placebo (38.8 per 1000 patient years; hazard ratio 1.03 (95% confidence interval 0.89 to 1.20, P = 0.65)). None of the components of the primary outcome was reduced. Ramipril lowered systolic and diastolic blood pressures (by 2.43 and 1.06 mm Hg respectively after two years) and favoured regression from microalbuminuria (20-200 mg/l) or proteinuria (> 200mg/l) to normal level (< 20 mg/l) or microalbuminuria (P < 0.07) in 1868 participants who completed the study.

conclusionsLow dose (1.25 mg) ramipril once daily has no effect on cardiovascular and renal outcomes of patients with type 2 diabetes and albuminuria, despite a slight decrease in blood pressure and urinary albumin. The cardiovascular benefits of a daily higher dose (10 mg) ramipril observed elsewhere are not found with an eightfold lower daily dose.

Indexed as

AgedAlbuminuriaAngiotensin-Converting Enzyme InhibitorsBlood PressureDiabetes Mellitus, Type 2Diabetic AngiopathiesDiabetic NephropathiesDouble-Blind MethodFemaleHumansMaleMiddle AgedRamiprilRisk FactorsTreatment OutcomeAngiotensin-Converting Enzyme InhibitorsRamipril

Identifiers

PMID14960504
PMCPMC351842
OpenAlexW2107860946

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.