Evidence map›Paper›PMID 24475922›Full record

Trial reportCardiovascular diabetology2014

The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus.

David Zi Cherney, Bruce A Perkins, Nima Soleymanlou, Ronnie Har, Nora Fagan, Odd Erik Johansen, Hans-Juergen Woerle, Maximilian von Eynatten, Uli C Broedl

2 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular diabetology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 214 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
214citing papers in PubMed, 9 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.

NCT03132181 phase2completedstarted 2017, after this paper: background citation

Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes

Ran2017Enrolled40Registered outcomes14Posted comparisons0ConditionsDiabetes Mellitus Type 2 (T2DM)Armsempagliflozin, Placebo
PMID 24939043PMID 24444522PMID 26343814PMID 23735727PMID 27299675PMID 26981940PMID 24026259other papers from this trial
Open the trial in the graph
NCT01392560 phase2completednot on this map

An Open-label 8-week Adjunctive-to-insulin and Renal Mechanistic Pilot Trial of BI 10773 in Type 1 Diabetes Mellitus (the ATIRMA Trial)

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2012Enrolled52ConditionsDiabetes Mellitus, Type 1ArmsBI 10773
3 · Its place in the literature

Who cites it

214 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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154 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

9 authors.

David Zi CherneyDivision of Nephrology, University Health Network, University of Toronto, Toronto General Hospital, 585 University Ave, Toronto 8N-845, M5G 2N2, Ontario, Canada. david.cherney@uhn.on.ca.
Bruce A Perkins
Nima Soleymanlou
Ronnie Har
Nora Fagan
Odd Erik Johansen
Hans-Juergen Woerle
Maximilian von Eynatten
Uli C Broedl

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndividuals with type 1 diabetes mellitus are at high risk for the development of hypertension, contributing to cardiovascular complications. Hyperglycaemia-mediated neurohormonal activation increases arterial stiffness, and is an important contributing factor for hypertension. Since the sodium glucose cotransport-2 (SGLT2) inhibitor empagliflozin lowers blood pressure and HbA1c in type 1 diabetes mellitus, we hypothesized that this agent would also reduce arterial stiffness and markers of sympathetic nervous system activity.

methodsBlood pressure, arterial stiffness, heart rate variability (HRV) and circulating adrenergic mediators were measured during clamped euglycaemia (blood glucose 4-6 mmol/L) and hyperglycaemia (blood glucose 9-11 mmol/L) in 40 normotensive type 1 diabetes mellitus patients. Studies were repeated after 8 weeks of empagliflozin (25 mg once daily).

resultsIn response to empagliflozin during clamped euglycaemia, systolic blood pressure (111 ± 9 to 109 ± 9 mmHg, p = 0.02) and augmentation indices at the radial (-52% ± 16 to -57% ± 17, p = 0.0001), carotid (+1.3 ± 1 7.0 to -5.7 ± 17.0%, p < 0.0001) and aortic positions (+0.1 ± 13.4 to -6.2 ± 14.3%, p < 0.0001) declined. Similar effects on arterial stiffness were observed during clamped hyperglycaemia without changing blood pressure under this condition. Carotid-radial pulse wave velocity decreased significantly under both glycemic conditions (p ≤ 0.0001), while declines in carotid-femoral pulse wave velocity were only significant during clamped hyperglycaemia (5.7 ± 1.1 to 5.2 ± 0.9 m/s, p = 0.0017). HRV, plasma noradrenalin and adrenaline remained unchanged under both clamped euglycemic and hyperglycemic conditions.

conclusionsEmpagliflozin is associated with a decline in arterial stiffness in young type 1 diabetes mellitus subjects. The underlying mechanisms may relate to pleiotropic actions of SGLT2 inhibition, including glucose lowering, antihypertensive and weight reduction effects.

trial registrationCLINICAL

trial registrationNCT01392560.

Indexed as

AdultBenzhydryl CompoundsBlood PressureCohort StudiesDiabetes Mellitus, Type 1FemaleGlucosidesHeart RateHumansMaleProspective StudiesTreatment OutcomeVascular StiffnessYoung AdultBenzhydryl CompoundsempagliflozinGlucosides

Identifiers

PMID24475922
PMCPMC3915232

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.