Evidence map›Paper›PMID 31064361›Full record

ArticleCardiovascular diabetology2019

Effect of ertugliflozin on blood pressure in patients with type 2 diabetes mellitus: a post hoc pooled analysis of randomized controlled trials.

Jie Liu, Annpey Pong, Silvina Gallo, Amanda Darekar, Steven G Terra

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Cardiovascular diabetology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01958671. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT01958671 phase3completed

A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

Ran2013Enrolled461Registered outcomes12Posted comparisons18ConditionsType 2 Diabetes MellitusArmsErtugliflozin 10 mg, Ertugliflozin 5 mg, Glimepiride, Metformin, Placebo to Ertugliflozin
PMID 28116776other papers from this trial
Open the trial in the graph
NCT02033889 phase3completed

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy.

Ran2013Enrolled621Registered outcomes49Posted comparisons42ConditionsType 2 Diabetes MellitusArmsBasal Insulin, Ertugliflozin 15 mg, Ertugliflozin 5 mg, Glimepiride, Metformin
PMID 28857451other papers from this trial
Open the trial in the graph
NCT02036515 phase3completed

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

Ran2014Enrolled464Registered outcomes24Posted comparisons40ConditionsType 2 Diabetes MellitusArmsErtugliflozin 15 mg, Ertugliflozin 5 mg, Glimepiride, Insulin, Metformin
PMID 28921862other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Blood Pressure-Lowering Effect of Newer Antihyperglycemic Agents (SGLT-2 Inhibitors, GLP-1 Receptor Agonists, and DPP-4 Inhibitors).American journal of cardiovascular drugs : drugs, devices, and other interventions · 2021
    Review
  6. Review
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 at 4 institutions in 3 countries.

Jie LiuMerck & Co., Inc., Kenilworth, NJ, USA. jie.liu11@merck.com.ORCID 0000-0002-5264-4612
Annpey PongMerck & Co., Inc., Kenilworth, NJ, USA.
Silvina GalloPfizer Pharma GmbH, Berlin, Germany.
Amanda DarekarPfizer R&D UK Ltd, Walton Oaks, Tadworth, UK.
Steven G TerraPfizer Inc., Andover, MA, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USPfizer (Germany) · DEPfizer (United Kingdom) · GBPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of ertugliflozin, a sodium-glucose cotransporter 2 inhibitor, for glycemic and blood pressure (BP) control has been demonstrated in phase 3 studies. To further evaluate the effects of ertugliflozin on BP and other hemodynamic parameters, an analysis was conducted on the pooled patient populations from these studies.

methodsThis was a post hoc analysis of data from three phase 3 studies (NCT01958671, NCT02033889, and NCT02036515) of adults with type 2 diabetes mellitus who received placebo, ertugliflozin 5 mg, or ertugliflozin 15 mg. Outcomes at 26 weeks were analyzed for the pooled population and according to relevant baseline factors, including BP.

resultsOf the 1544 patients included (placebo, n = 515; ertugliflozin 5 mg, n = 519; ertugliflozin 15 mg, n = 510), most (67.4-69.0%) had hypertension at baseline. Mean baseline BP was similar across treatment groups (placebo, 129.7/78.0 mmHg; ertugliflozin 5 mg, 131.0/78.4 mmHg; ertugliflozin 15 mg, 130.5/78.4 mmHg). At Week 26, placebo-adjusted least squares (LS) mean changes (95% confidence intervals [CI]) from baseline in systolic BP (SBP) were - 3.7 mmHg (- 5.1, - 2.3) for both ertugliflozin doses. Reductions were consistent across all baseline subgroups. At Week 26, more patients with a baseline SBP ≥ 130 mmHg had a SBP < 130 mmHg with ertugliflozin (38.7% both doses) than with placebo (24.0%), and more patients with a baseline SBP ≥ 140 mmHg attained a SBP < 140 mmHg with ertugliflozin (59.5% [5 mg] and 66.7% [15 mg]) than with placebo (43.8%). Placebo-adjusted LS mean changes (95% CI) in diastolic BP (DBP) with ertugliflozin 5 mg and 15 mg were - 1.8 mmHg (- 2.7, - 0.9) and - 1.6 mmHg (- 2.5, -  0.7), respectively, and in pulse rate were - 1.3 beats per minute (bpm) (- 2.2, - 0.3) and - 1.5 bpm (- 2.5, - 0.6), respectively. Greater reductions in pulse pressure, mean arterial pressure, and double product were observed with ertugliflozin than with placebo. Incidence of adverse event-related osmotic diuresis was low, but greater with ertugliflozin (2.9% [5 mg], 2.4% [15 mg]) than placebo (1.0%).

conclusionErtugliflozin treatment led to reductions in SBP, DBP, and pulse rate relative to placebo. Reductions in SBP were generally consistent across the subgroups evaluated. Trial registration NCT01958671; NCT02033889; NCT02036515.

Indexed as

AgedAntihypertensive AgentsBiomarkersBlood GlucoseBlood PressureBridged Bicyclo Compounds, HeterocyclicDiabetes Mellitus, Type 2FemaleHeart RateHumansHypertensionMaleMiddle AgedRandomized Controlled Trials as TopicSodium-Glucose Transporter 2 InhibitorsTime FactorsAntihypertensive AgentsBiomarkersBlood GlucoseBridged Bicyclo Compounds, HeterocyclicertugliflozinSodium-Glucose Transporter 2 InhibitorsBlood pressureDiastolic blood pressureErtugliflozinHypertensionPulse rateSodium–glucose cotransporter 2 inhibitorSystolic blood pressureType 2 diabetes mellitus

Identifiers

PMID31064361
PMCPMC6503446
OpenAlexW2947116369

What OpenQuestion 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 OpenQuestion graph.