Evidence map›Paper›PMID 18525041›Full record

Trial reportThe New England journal of medicine2008

Aliskiren combined with losartan in type 2 diabetes and nephropathy.

Hans-Henrik Parving, Frederik Persson, Julia B Lewis, Edmund J Lewis, Norman K Hollenberg, AVOID Study Investigators

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00097955 (Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria), which is not on this map. Cited by 320 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
320citing papers in PubMed, 17 pooled it
106.7field-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.

NCT00097955 phase2completednot on this map

Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

TypeinterventionalSponsorNovartis PharmaceuticalsRan2004 to 2007Enrolled496ConditionsDiabetic NephropathyArmsaliskiren
3 · Its place in the literature

Who cites it

320 citing papers in PubMed, 17 syntheses or guidelines pooled it, 1,104 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
    Pooled it
  4. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  5. Guideline
  6. Pooled it
  7. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019).Hypertension research : official journal of the Japanese Society of Hypertension · 2019
    Guideline
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  9. THE IMPACT OF CARDIOVASCULAR DRUGS ON GLYCEMIC CONTROL: A REVIEW.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2017
    Pooled it
  10. Guideline
  11. Assessing the Validity of Surrogate Outcomes for ESRD: A Meta-Analysis.Journal of the American Society of Nephrology : JASN · 2015
    Pooled it
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  17. Guideline
  18. Trial
  19. Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 2 countries.

Hans-Henrik ParvingDepartment of Medical Endocrinology, Rigshospitalet, Copenhagen, Denmark. hhparving@dadlnet.dk
Frederik Persson
Julia B Lewis
Edmund J Lewis
Norman K Hollenberg
AVOID Study Investigators
Brigham and Women's Hospital · USRigshospitalet · DKRush University Medical Center · USSteno Diabetes Center · DKVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDiabetic nephropathy is the leading cause of end-stage renal disease in developed countries. We evaluated the renoprotective effects of dual blockade of the renin-angiotensin-aldosterone system by adding treatment with aliskiren, an oral direct renin inhibitor, to treatment with the maximal recommended dose of losartan (100 mg daily) and optimal antihypertensive therapy in patients who had hypertension and type 2 diabetes with nephropathy.

methodsWe enrolled 599 patients in this multinational, randomized, double-blind study. After a 3-month, open-label, run-in period during which patients received 100 mg of losartan daily, patients were randomly assigned to receive 6 months of treatment with aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months) or placebo, in addition to losartan. The primary outcome was a reduction in the ratio of albumin to creatinine, as measured in an early-morning urine sample, at 6 months.

resultsThe baseline characteristics of the two groups were similar. Treatment with 300 mg of aliskiren daily, as compared with placebo, reduced the mean urinary albumin-to-creatinine ratio by 20% (95% confidence interval, 9 to 30; P<0.001), with a reduction of 50% or more in 24.7% of the patients who received aliskiren as compared with 12.5% of those who received placebo (P<0.001). A small difference in blood pressure was seen between the treatment groups by the end of the study period (systolic, 2 mm Hg lower [P=0.07] and diastolic, 1 mm Hg lower [P=0.08] in the aliskiren group). The total numbers of adverse and serious adverse events were similar in the groups.

conclusionsAliskiren may have renoprotective effects that are independent of its blood-pressure-lowering effect in patients with hypertension, type 2 diabetes, and nephropathy who are receiving the recommended renoprotective treatment. (ClinicalTrials.gov number, NCT00097955 [ClinicalTrials.gov].).

Indexed as

Renin InhibitorsAdolescentAdultAgedAged, 80 and overAlbuminuriaAmidesAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsCreatinineDiabetes Mellitus, Type 2Diabetic NephropathiesDouble-Blind MethodDrug Therapy, CombinationFemaleFumaratesaliskirenAmidesAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsCreatinineFumaratesLosartanRenin Inhibitors

Identifiers

PMID18525041
OpenAlexW2145632481

What OpenQuestion holds

Textmetadata
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.