Evidence map›Paper›PMID 30362146›Full record

Trial reportBritish journal of clinical pharmacology2019

Pharmacokinetics and pharmacodynamics of ropinirole in patients with prolactinomas.

Sihang Liu, Can Hu, Jane Peters, Amanda Tsang, Serge Cremers, Robert Bies, Gabrielle Page-Wilson

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03038308 (Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole), 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
0.2field-weighted citation impact, top 42% 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.

NCT03038308 phase1 / phase2completednot on this map

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability

TypeinterventionalSponsorColumbia UniversityRan2016 to 2020Enrolled16ConditionsHyperprolactinemia, ProlactinomaArmsRopinirole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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 3 institutions in 1 country.

Sihang LiuState University of New York at Buffalo, Buffalo, NY, USA.
Can HuCollege of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.
Jane PetersCollege of Physicians and Surgeons, Columbia University, New York, NY, USA.
Amanda TsangCollege of Physicians and Surgeons, Columbia University, New York, NY, USA.
Serge CremersCollege of Physicians and Surgeons, Columbia University, New York, NY, USA.
Robert BiesState University of New York at Buffalo, Buffalo, NY, USA.
Gabrielle Page-WilsonCollege of Physicians and Surgeons, Columbia University, New York, NY, USA.ORCID 0000-0002-4064-1211
Columbia University · USUniversity at Buffalo, State University of New York · USSUNY Downstate Health Sciences University · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
A New Therapeutic Option for the Treatment of ProlactinomasR21DK112093 · NIDDK · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI PAGEWILSON, GABRIELLE · 2016 to 2018
$600k
NCATS NIH HHS UL1 TR000040NCRR NIH HHS UL1 RR024156NIDDK NIH HHS R21 DK112093
6 · The paper itself

Abstract

aimsTreatment of prolactinomas with ergoline dopamine agonists can be complicated by intolerance and resistance. This study investigated the pharmacokinetics and pharmacodynamics of the nonergot dopamine agonist ropinirole, to assess its therapeutic potential as a novel therapy for prolactinomas.

methodsFive female subjects with prolactinomas participated in this dose-response study. Subjects received up to three doses of ropinirole (0.5, 1.0 and 2.0 mg), each on separate occasions. Frequent blood samples for prolactin and ropinirole were collected for 24 h following drug administration. Data were analysed using noncompartmental and compartmental pharmacokinetic-pharmacodynamic (PKPD) techniques.

resultsSeven 24-h curves revealed increased systemic drug exposure with increasing ropinirole doses. Ropinirole concentrations peaked at 4.4 ± 2.7 h and exhibited a half-life of 5.8 ± 1.7 h. A dose-dependent prolactin nadir occurred 4.4 ± 1.2 h after drug intake and prolactin concentrations transiently normalized in two of five subjects. PKPD modelling revealed that single-dose PK of ropinirole is dose-independent and can be described with a one-compartment model with linear absorption and elimination. An indirect response model successfully captures the inhibitory effect of ropinirole on prolactin secretion and incorporates time-dependent receptor desensitization for three of five subjects whose prolactin concentrations nadired before ropinirole reached C

conclusionsThis data-rich study has informed our understanding of the clinical pharmacokinetics and pharmacodynamics of ropinirole, which are successfully captured by the proposed semi-mechanistic PKPD model. This model can be used to further investigate the PKPD of ropinirole and may facilitate the identification of optimal dose regimens for the treatment of prolactinomas and the establishment of a new therapeutic option for patients impacted by this rare disease.

Indexed as

AdultAgedDopamine AgonistsDose-Response Relationship, DrugFemaleHalf-LifeHumansIndolesMiddle AgedModels, BiologicalPituitary NeoplasmsProlactinProlactinomaTreatment OutcomeYoung AdultDopamine AgonistsIndolesProlactinropinirolemodelling and simulationpharmacokinetic-pharmacodynamicpharmacometricsropiniroletherapeutics

Identifiers

PMID30362146
PMCPMC6339972
OpenAlexW2898453126

What OpenQuestion holds

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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.