Evidence map›Paper›PMID 32897570›Full record

Trial reportClinical pharmacology and therapeutics2021

Effects of the Dual Endothelin Receptor Antagonist Aprocitentan on Body Weight and Fluid Homeostasis in Healthy Subjects on a High Sodium Diet.

Pierre Gueneau de Mussy, Patricia N Sidharta, Gregoire Wuerzner, Marc P Maillard, Nicolas Guérard, Marc Iglarz, Bruno Flamion, Jasper Dingemanse, Michel Burnier

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.6field-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.

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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Aprocitentan: A new development of resistant hypertension.Journal of clinical hypertension (Greenwich, Conn.) · 2023
    Review
  8. Article
  9. Review
  10. Review
  11. 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

9 authors at 2 institutions in 1 country.

Pierre Gueneau de MussyService of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.
Patricia N SidhartaDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Gregoire WuerznerService of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.
Marc P MaillardService of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.
Nicolas GuérardDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Marc IglarzDepartment of Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Bruno FlamionDepartment of Strategic Development, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Jasper DingemanseDepartment of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.
Michel BurnierService of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.
Idorsia (Switzerland) · CHUniversity of Lausanne · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aprocitentan is a novel, oral, dual endothelin receptor antagonist (ERA) in development in difficult-to-control hypertension. As fluid retention and edema are concerns with ERAs, we investigated whether aprocitentan causes weight gain in healthy subjects on a high sodium diet and explored potential mechanisms if occurring. This double-blind, randomized, placebo-controlled, crossover study enrolled 28 subjects. Three doses of aprocitentan (10, 25, or 50 mg/day for 9 days) were compared with placebo. Increases in body weight were observed with aprocitentan (placebo-corrected mean weight gains [90% confidence interval]) of 0.43 [0.05-0.80], 0.77 [0.03-1.51], and 0.83 [0.33-1.32] kg at 10 mg, 25 mg, and 50 mg, respectively. Decreases in hemoglobin and uric acid were observed. Plasma volume increased at most by 5.5% without dose-response relationship. Urinary sodium excretion decreased at 10 mg and 25 mg but not at 50 mg. Therefore, aprocitentan produced moderate weight increases in healthy subjects on high sodium diet, without obvious sodium retention.

Indexed as

Administration, OralAdultAldosteroneBody WaterCross-Over StudiesDouble-Blind MethodEndothelin Receptor AntagonistsGlycopeptidesHealthy VolunteersHomeostasisHumansMaleMiddle AgedNatriuresisPyrimidinesSodium, DietaryAldosteroneaprocitentancopeptinsEndothelin Receptor AntagonistsGlycopeptidesPyrimidinesSodium, DietarySulfonamidesUric Acid

Identifiers

PMID32897570
PMCPMC7984323
OpenAlexW3083976079

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.