Evidence map›Paper›PMID 26936519›Full record

Trial reportDiabetes, obesity & metabolism2016

Dapagliflozin reduces albuminuria in patients with diabetes and hypertension receiving renin-angiotensin blockers.

H J L Heerspink, E Johnsson, I Gause-Nilsson, V A Cain, C D Sjöström

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

94 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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34 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

5 authors.

H J L HeerspinkUniversity of Groningen, University Medical Center, Groningen, The Netherlands.
E JohnssonAstraZeneca, Gothenburg, Mölndal, Sweden.
I Gause-NilssonAstraZeneca, Gothenburg, Mölndal, Sweden.
V A CainAstraZeneca, Wilmington, DE, USA.
C D SjöströmAstraZeneca, Gothenburg, Mölndal, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo characterize the effect of dapagliflozin on albuminuria and estimated glomerular filtration rate (eGFR) and to determine whether effects on albuminuria were mediated through changes in glycated haemoblogin (HbA1c), systolic blood pressure (SBP), body weight or eGFR.

methodsWe conducted a post hoc analysis of data pooled from two phase III clinical trials in hypertensive patients with type 2 diabetes (T2DM) on stable angiotensin-converting enzyme inhibitor or angiotensin receptor blocker therapy, randomly assigned to dapagliflozin 10 mg/day or matched placebo. This analysis included only patients with microalbuminuria or macroalbuminuria at baseline.

resultsPatients were randomized to receive dapagliflozin 10 mg (n = 167) or placebo (n = 189). Dapagliflozin resulted in greater 12-week reductions in albuminuria compared with placebo: -33.2% [95% confidence interval (CI) -45.4, -18.2]. The reduction in albuminuria was also present after adjusting for age, sex and changes in HbA1c, SBP, body weight and eGFR: -23.5% (95% CI -37.6, -6.3). There was a decrease in eGFR with dapagliflozin versus placebo that was readily reversed 1 week after last dose. No serious renal-related adverse events were observed in any group.

conclusionsDapagliflozin was effective in lowering albuminuria in patients with T2DM and hypertension using renin-angiotensin system blockade therapy. Reductions in albuminuria were still present after adjusting for changes in HbA1c, SBP, body weight and eGFR. Dapagliflozin-induced improvements in glycaemic control and reductions in SBP, coupled with other potentially beneficial renal effects, may lead to a reduced long-term renal and cardiovascular risk.

Indexed as

AgedAlbuminuriaAngiotensin-Converting Enzyme InhibitorsBenzhydryl CompoundsBlood GlucoseBlood PressureDiabetes Mellitus, Type 2FemaleGlomerular Filtration RateGlucosidesGlycated HemoglobinHumansHypertensionMaleMiddle AgedRenin-Angiotensin SystemAngiotensin-Converting Enzyme InhibitorsBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated Hemoglobinalbuminuriadapagliflozindiabeteshypertensionsodium glucose cotransporter-2

Identifiers

PMID26936519
PMCPMC4850750

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Registered trials

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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.