Evidence mapPaperPMID 25271206Full record

Trial reportDiabetes care2015

Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension.

Ilkka Tikkanen, Kirsi Narko, Cordula Zeller, Alexandra Green, Afshin Salsali, Uli C Broedl, Hans J Woerle, EMPA-REG BP Investigators

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 240 papers, 27 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
240citing papers in PubMed, 27 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.

NCT04183868 phase4completedstarted 2016, after this paper: background citation

Comparative Effects of Empagliflozin Versus Glimepiride After 26-weeks of Treatment Add on Metformin on Myocardial Metabolic Rate of Glucose Estimated Through 18FDG-PET in Patients With Type 2 Diabetes

Ran2016Enrolled26Registered outcomes10Posted comparisons0ConditionsCardiovascular Risk Factor, Type 2 DiabetesArmsempagliflozin 10 mg, Glimepiride 2 mg
Open the trial in the graph
NCT05037695 phase4unknown statusstarted 2021, after this paper: background citation

SGLT-2 Inhibitors in Prevention of Post-procedural Renal and Cardiovascular Complications aFter PCI Among Patients With Diabetes Mellitus and Coronary Artery Disease: a Prospective, Randomized, Pilot Study (SAFE-PCI)

Ran2021Enrolled40Registered outcomes17Posted comparisons0ConditionsAcute Kidney Injury, Coronary Artery Disease, Diabetes Mellitus, Type 2Armsempagliflozin 25 mg
Open the trial in the graph
NCT05194592 phase4unknown statusstarted 2022, after this paper: background citation

Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes

Ran2022Enrolled122Registered outcomes4Posted comparisons0ConditionsRemodeling, Ventricular, Type2 DiabetesArmsdapagliflozin, Gemigliptin
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3 · Its place in the literature

Who cites it

240 citing papers in PubMed, 27 syntheses or guidelines pooled it.

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180 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

8 authors.

Ilkka TikkanenDepartment of Medicine, Helsinki University Central Hospital, and Minerva Institute for Medical Research, Helsinki, Finland ilkka.tikkanen@hus.fi.
Kirsi NarkoBoehringer Ingelheim Finland Ky, Helsinki, Finland.
Cordula ZellerBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Alexandra GreeninVentiv Health Clinical, Maidenhead, U.K.
Afshin SalsaliBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Uli C BroedlBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Hans J WoerleBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
EMPA-REG BP Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy, safety, and tolerability of empagliflozin in patients with type 2 diabetes and hypertension. RESEARCH DESIGN AND

methodsPatients (N = 825) with type 2 diabetes and hypertension (mean seated systolic blood pressure [SBP] 130-159 mmHg and diastolic blood pressure [DBP] 80-99 mmHg) were randomized (double blind) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks.

resultsAt week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h SBP (ambulatory blood pressure monitoring [ABPM]) was -3.44 mmHg (95% CI -4.78, -2.09) with 10 mg empagliflozin and -4.16 mmHg (-5.50, -2.83) with 25 mg empagliflozin (both P < 0.001). At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h DBP (ABPM) was -1.36 mmHg (95% CI -2.15, -0.56) with 10 mg empagliflozin and -1.72 mmHg (95% CI -2.51, -0.93) with 25 mg empagliflozin (both P < 0.001). Changes in office BP were consistent with ABPM. Adjusted mean difference versus placebo in change from baseline in HbA1c at week 12 was -0.62% (95% CI -0.72, -0.52) (-6.8 mmol/mol [95% CI -7.9, -5.7]) with 10 mg empagliflozin and -0.65% (95% CI -0.75, -0.55) (-7.1 mmol/mol [95% CI -8.2, -6.0]) with 25 mg empagliflozin (both P < 0.001). Empagliflozin was well tolerated. One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion.

conclusionsEmpagliflozin was associated with significant and clinically meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension.

Indexed as

Analysis of VarianceAntihypertensive AgentsBenzhydryl CompoundsBlood PressureBlood Pressure Monitoring, AmbulatoryDiabetes Mellitus, Type 2Diabetic AngiopathiesDouble-Blind MethodDrug Administration ScheduleFemaleGlucosidesGlycated HemoglobinHumansHypertensionHypoglycemic AgentsMaleAntihypertensive AgentsBenzhydryl CompoundsempagliflozinGlucosidesGlycated HemoglobinHypoglycemic Agents

Identifiers

PMID25271206

What Socratic 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 Socratic graph.