Evidence map›Paper›PMID 19451554›Full record

Trial reportAnnals of internal medicine2009

Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials.

Rudy Bilous, Nish Chaturvedi, Anne Katrin Sjølie, John Fuller, Ronald Klein, Trevor Orchard, Massimo Porta, Hans-Henrik Parving

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Annals of internal medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 83 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 14 pooled it
20.3field-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

83 citing papers in PubMed, 14 syntheses or guidelines pooled it, 256 citations in OpenAlex.

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  9. Antihypertensive agents for preventing diabetic kidney disease.The Cochrane database of systematic reviews · 2012
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  11. Guideline
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  13. Guideline
  14. Standards of medical care in diabetes--2010.Diabetes care · 2010 · on this map
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 4 countries.

Rudy BilousNewcastle University, Newcastle upon Tyne, United Kingdom.
Nish Chaturvedi
Anne Katrin Sjølie
John Fuller
Ronald Klein
Trevor Orchard
Massimo Porta
Hans-Henrik Parving
University College London · GBNewcastle upon Tyne Hospital · GBUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMicroalbuminuria in diabetes is strongly predictive of nephropathy, end-stage renal disease, and premature cardiovascular morbidity and mortality. Effective preventive therapies are therefore a clinical priority.

objectiveTo determine whether the angiotensin-receptor blocker candesartan compared with placebo affects microalbuminuria incidence or rate of change in albuminuria in type 1 and type 2 diabetes.

design3 randomized trials of the DIRECT (Diabetic Retinopathy Candesartan Trials) Program.

setting309 secondary care centers. PATIENTS: 3326 and 1905 patients with type 1 and type 2 diabetes, respectively. Most were normotensive, and all had normoalbuminuria (median urinary albumin excretion rate, 5.0 microg/min).

interventionCandesartan, 16 mg/d increasing to 32 mg/d, versus placebo. Assignment was done centrally using an interactive voice-response system. Patients, caregivers, and researchers were blinded to treatment assignment. During a median follow-up of 4.7 years, 793 patients discontinued therapy and 63 were lost to follow-up. MEASUREMENTS: Urinary albumin excretion rate, assessed annually by 2 overnight collections; if it was 20 microg/min or greater, then 2 further collections were done. The primary end point was new microalbuminuria (3 or 4 collections of urinary albumin excretion rate >or=20 microg/min). The secondary end point was rate of change in albuminuria.

resultsIndividual and pooled results of the 3 trials showed that candesartan had little effect on risk for microalbuminuria (pooled hazard ratio, 0.95 [95% CI, 0.78 to 1.16]; P = 0.60). Pooled results showed that the annual rate of change in albuminuria was 5.53% lower (CI, 0.73% to 10.14%; P = 0.024) with candesartan than with placebo. LIMITATIONS: Investigators recruited mainly normotensive patients or patients with well-controlled hypertension who were at low overall vascular risk, which resulted in a low rate of microalbuminuria. Studies were powered for retinal and not renal end points.

conclusionCandesartan, 32 mg/d, for 4.7 years did not prevent microalbuminuria in mainly normotensive patients with type 1 or type 2 diabetes.

Indexed as

AdultAgedAlbuminuriaAngiotensin II Type 1 Receptor BlockersBenzimidazolesBiphenyl CompoundsDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodFemaleHumansHyperkalemiaMaleMiddle AgedTetrazolesAngiotensin II Type 1 Receptor BlockersBenzimidazolesBiphenyl CompoundscandesartanTetrazoles

Identifiers

PMID19451554
OpenAlexW2054454858

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.