Evidence map›Paper›PMID 27860389›Full record

Trial reportCardiovascular therapeutics2017

Efficacy and safety of two dosages of canrenone as add-on therapy in hypertensive patients taking ace-inhibitors or angiotensin II receptor blockers and hydrochlorothiazide at maximum dosage in a randomized clinical trial: The ESCAPE-IT trial.

Giuseppe Derosa, Pamela Maffioli, Maria D'Avino, Carla Sala, Amedeo Mugellini, Vito Vulpis, Salvatore Felis, Luigina Guasti, Riccardo Sarzani, Alessandro Bestetti and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
In one paragraph

Trial report in Cardiovascular therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02687178 (Efficacy and Safety of Canrenone as Add-on in Patients With Essential Hypertension-Italy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 18% 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.

NCT02687178 phase4completednot on this map

Efficacy and Safety of Canrenone as Add-on in Patients With Essential Hypertension-Italy (ESCAPE-IT)

TypeinterventionalSponsorUniversity of PaviaRan2010 to 2016Enrolled180ConditionsEssential HypertensionArmsCanrenone 50 vs canrenone 100 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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

13 authors at 10 institutions in 2 countries.

Giuseppe DerosaDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
Pamela MaffioliDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
Maria D'AvinoUnit for the treatment of Arterial Hypertension, Ospedale Cardarelli, Napoli, Italy.
Carla SalaUnit of Cardiovascular Diseases, Fondazione Policlinico Milano, Milano, Italy.
Amedeo MugelliniDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
Vito VulpisUnit for the Diagnosis and Treatment of Arterial Hypertension, Department of Internal Medicine, Policlinico di Bari, Bari, Italy.
Salvatore FelisCardiology Unit, Ospedale Garibaldi, Catania, Italy.
Luigina GuastiResearch Center on Dyslipidemia, Internal Medicine 1, University of Insubria, Varese, Italy.
Riccardo SarzaniCenter for the treatment of Hypertension and Cardiovascular Diseases, Ospedali Riuniti di Torrette, Ancona, Italy.
Alessandro BestettiTHERABEL GiEnne Pharma, Milano, Italy.
Massimo VanasiaTHERABEL GiEnne Pharma, Milano, Italy.
Giovanni GaudioInternal Medicine Division, Ospedale Angelo Bellini, Somma Lombardo, Varese, Italy.
ESCAPE-IT Trial Investigators group
Bridge Pharma (United States) · USUniversity of Pavia · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITOspedale Antonio Cardarelli · ITOspedale dell' Angelo · ITOspedale Garibaldi · ITOspedali Riuniti di Ancona · ITPoliclinico San Matteo Fondazione · ITUniversity of Bari Aldo Moro · ITUniversity of Insubria · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the effects of canrenone as add-on therapy in patients already treated with angiotensin-converting enzyme inhibitors (ACE-I) or angiotensin II receptor blockers (ARBs) and hydrochlorothiazide at the maximum dosage (25 mg/d).

methodIn this randomized, open-label, controlled trial, we enrolled 175 Caucasian patients with essential hypertension not well controlled by concomitant ACE-I or ARBs and hydrochlorothiazide. At baseline, 87 patients (57 males and 30 females) were randomized to add canrenone 50 mg, and 88 (56 males and 32 females) patients to canrenone 100 mg, once a day, for 3 months. At baseline and after 3 months, we evaluated blood pressure (BP), pulse pressure (PP), heart rate (HR), fasting plasma glucose (FPG), homeostasis model assessment insulin (HOMA Index), lipid profile, electrolytes, uric acid, estimated glomerular filtration rate (eGFR), plasma urea, aldosterone, B-type natriuretic peptide (BNP), and galectin-3.

resultsBlood pressure decreased with both dosages of canrenone, with a better effect with canrenone 100 mg (-20.26 vs -23.68 mm Hg for SBP, and -10.58 vs -12.38 mm Hg for DBP), without a clinically relevant increase in potassium levels. We did not observe any differences regarding FPG or HOMA Index, nor of lipid profile, with the exception of triglycerides, which increased compared to baseline with canrenone 50 mg (+0.25 vs +0.34 mEq/L). Creatinine slightly increased with canrenone 100 mg (+0.02 vs +0.05 mg/dL), although no variations of eGFR were observed in neither groups. There was an increase in aldosterone levels with canrenone 50 mg. No changes in BNP or galectin-3 were recorded.

conclusionBoth canrenone dosages gave a decrease in blood pressure, with a better effect with the higher dose, with only a slight increase in potassium and creatinine levels, which were not clinically relevant. Clinical Trials Registration Eudract number: 2010-023606-13; ClinicalTrials.gov NCT02687178.

Indexed as

AgedAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBiomarkersBlood PressureCanrenoneDrug Therapy, CombinationEssential HypertensionFemaleHumansHydrochlorothiazideHypertensionItalyMaleMiddle AgedAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersAntihypertensive AgentsBiomarkersCanrenoneHydrochlorothiazideMineralocorticoid Receptor AntagonistsSodium Chloride Symporter InhibitorsAngiotensin-converting enzyme inhibitorsAngiotensin II receptor blockersCanrenoneHydrochlorothiazideHypertension

Identifiers

PMID27860389
PMCPMC6680336
OpenAlexW2553280382

What OpenQuestion holds

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LicenceCC BY-NC
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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.