Evidence map›Paper›PMID 26273191›Full record

Trial reportDrug design, development and therapy2015

Randomized, open-label, blinded-endpoint, crossover, single-dose study to compare the pharmacodynamics of torasemide-PR 10 mg, torasemide-IR 10 mg, and furosemide-IR 40 mg, in patients with chronic heart failure.

Maria Rosa Ballester, Eulàlia Roig, Ignasi Gich, Montse Puntes, Joaquín Delgadillo, Benjamín Santos, Rosa Maria Antonijoan

Open access · goldAbstract readClinical Trial, Phase IComparative StudyMulticenter Study
In one paragraph

Trial report in Drug design, development and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 33% 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
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

7 authors at 4 institutions in 2 countries.

Maria Rosa BallesterDrug Research Center (CIM), Biomedical Research Institute Sant Pau (IIB Sant Pau), Hospital de la Santa Creu i Sant Pau, Barcelona, Spain ; Pharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
Eulàlia RoigCardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain ; Universitat Autònoma de Barcelona (UAB) Bellaterra, Spain.
Ignasi GichDrug Research Center (CIM), Biomedical Research Institute Sant Pau (IIB Sant Pau), Hospital de la Santa Creu i Sant Pau, Barcelona, Spain ; Pharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
Montse PuntesDrug Research Center (CIM), Biomedical Research Institute Sant Pau (IIB Sant Pau), Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Joaquín DelgadilloPharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain ; Scientific Area, Ferrer Internacional, SA, Spain.
Benjamín SantosScientific Area, Ferrer Internacional, SA, Spain.
Rosa Maria AntonijoanDrug Research Center (CIM), Biomedical Research Institute Sant Pau (IIB Sant Pau), Hospital de la Santa Creu i Sant Pau, Barcelona, Spain ; Pharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.
Hospital de Sant Pau · ESUniversitat Autònoma de Barcelona · ESBiomedical Research Institute · USFerrer Grupo (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDiuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics.

methodsRandomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours.

resultsTen patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096 ± 0.03 mmol/μg vs 0.015 ± 0.0007 mmol/μg; P < 0.0001). Mictional urgency was lower and more delayed with torasemide-PR than with furosemide-IR.

conclusionIn a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to assess its impact on clinical therapeutics.

Indexed as

AgedAged, 80 and overChemistry, PharmaceuticalChronic DiseaseCross-Over StudiesDelayed-Action PreparationsFurosemideHeart FailureHumansMiddle AgedNatriuresisSodium Potassium Chloride Symporter InhibitorsSpainSulfonamidesTime FactorsTorsemideDelayed-Action PreparationsFurosemideSodium Potassium Chloride Symporter InhibitorsSulfonamidesTorsemidecontrolled-release preparationefficiencyfurosemideheart failurepharmacodynamicstorasemide

Identifiers

PMID26273191
PMCPMC4532344
OpenAlexW1852552079

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.