Evidence map›Paper›PMID 28556581›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2017

Population Modeling of Selexipag Pharmacokinetics and Clinical Response Parameters in Patients With Pulmonary Arterial Hypertension.

A Krause, M Machacek, D Lott, N Hurst, S Bruderer, J Dingemanse

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. 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

6 authors at 1 institution in 1 country.

A KrauseDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
M MachacekLixoft, Modelling and Pharmacology, Antony, France.
D LottDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
N HurstDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
S BrudererDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
J DingemanseDepartment of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Actelion (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Selexipag (Uptravi) is an oral selective IP prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension (PAH). The pivotal GRIPHON study was the largest clinical study ever conducted in PAH patients, providing long-term data from 1,156 patients. PAH comedication did not affect exposure to selexipag, while exposure to its active metabolite ACT-333679 was reduced by 30% when taken in combination, clinically not relevant in the context of individual dose up-titration. Using log-linear regression models linking model-predicted steady-state exposure to pharmacodynamics (PD), exposure to selexipag and ACT-333679 showed some statistically significant, albeit not clinically relevant, effects on exercise capacity, laboratory values, and the occurrence of prostacyclin-related adverse events, but not on vital signs or adverse events denoting hemorrhage. Using suitable modeling techniques, the GRIPHON study yielded clinically relevant data with limited burden of pharmacokinetics (PK) blood sampling, demonstrating that PK/PD modeling enables firm conclusions even with sparse PK and PD sampling.

Indexed as

Models, BiologicalAcetamidesAcetatesAdultAntihypertensive AgentsBilirubinDouble-Blind MethodExercise ToleranceFemaleHumansHypertension, PulmonaryLeukocyte CountMaleNatriuretic Peptide, BrainPeptide FragmentsPyrazines(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)acetic acidAcetamidesAcetatesAntihypertensive AgentsBilirubinNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Pyrazinesselexipag

Identifiers

PMID28556581
PMCPMC5529739
OpenAlexW2619761992

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.