Evidence map›Paper›PMID 25013998›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2014

Changes in plasma ACTH levels and corticotroph tumor size in patients with Cushing's disease during long-term treatment with the glucocorticoid receptor antagonist mifepristone.

Maria Fleseriu, James W Findling, Christian A Koch, Sven-Martin Schlaffer, Michael Buchfelder, Coleman Gross

Open access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 3% 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

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.

  1. Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline.The Journal of clinical endocrinology and metabolism · 2015
    Guideline
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  19. Management of Nelson's Syndrome.Medicina (Kaunas, Lithuania) · 2022
    Review
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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 5 institutions in 2 countries.

Maria FleseriuOregon Health & Science University (M.F.), Portland, Oregon 97239; Medical College of Wisconsin (J.W.F.), Milwaukee, Wisconsin 53051; University of Mississippi Medical Center (C.A.K.), Jackson, Mississippi 39216; University of Erlangen-Nürnberg (S.-M.S., M.B.), 91054 Erlangen, Germany; and Corcept Therapeutics (C.G.), Menlo Park, California 94025.
James W Findling
Christian A Koch
Sven-Martin Schlaffer
Michael Buchfelder
Coleman Gross
Friedrich-Alexander-Universität Erlangen-Nürnberg · DECorcept Therapeutics (United States) · USJackson Memorial Hospital · USMedical College of Wisconsin · USOregon Health & Science University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextPituitary effects of long-term therapy with mifepristone, a glucocorticoid receptor antagonist, in Cushing's disease (CD) patients are not well understood.

objectiveOur objective was to report changes in ACTH and pituitary magnetic resonance imaging (MRI) findings during long-term use of mifepristone in CD patients. DESIGN AND

settingThe Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing's Syndrome (SEISMIC) was a 24-week, open-label study of mifepristone, and its long-term extension (LTE) is a multicenter U.S. study. PATIENTS: Forty-three CD patients (mean age 45.3 years) were enrolled in SEISMIC with 27 continuing into the LTE study.

interventionsMifepristone (300-1200 mg) was administered once daily.

main outcome measuresACTH and pituitary MRI were assessed at baseline and at regular intervals during treatment.

resultsA ≥2-fold increase in ACTH was observed in 72% of patients treated for a median duration of 11.3 months. The mean peak increase in ACTH was 2.76 ± 1.65-fold during SEISMIC, and mean ACTH concentrations remained stable during the LTE. ACTH was directly correlated with mifepristone dose and declined to near baseline levels after mifepristone discontinuation. Tumor regressed in 2 patients and progressed in 3 patients with macroadenomas. An additional microadenoma was identified after 25 months of treatment after a baseline tumor-negative MRI.

conclusionsIn the largest prospective study to date, long-term mifepristone treatment increased ACTH in approximately two-thirds of patients with CD. ACTH elevations were observed within the first few weeks of treatment, were dose-dependent, and generally remained stable over time. Corticotroph tumor progression and regression may occur over time, but patients may have significant increases in ACTH levels without evidence of tumor growth.

Indexed as

AdenomaAdrenocorticotropic HormoneAdultCorticotrophsFemaleHormone AntagonistsHumansHydrocortisoneMagnetic Resonance ImagingMaleMiddle AgedMifepristonePituitary ACTH HypersecretionPituitary NeoplasmsProspective StudiesReceptors, GlucocorticoidAdrenocorticotropic HormoneHormone AntagonistsHydrocortisoneMifepristoneReceptors, Glucocorticoid

Identifiers

PMID25013998
PMCPMC4399272
OpenAlexW2160912499

What OpenQuestion holds

Textmetadata
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.