Evidence map›Paper›PMID 23943009›Full record

Trial reportPituitary2014

Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study.

M Boscaro, J Bertherat, J Findling, M Fleseriu, A B Atkinson, S Petersenn, J Schopohl, P Snyder, G Hughes, A Trovato and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pituitary, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00171951 (Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT00171951 phase2completednot on this map

Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2004 to 2013Enrolled19ConditionsCushing DiseaseArmsPasireotide
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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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

13 authors at 11 institutions in 6 countries.

M BoscaroDivision of Endocrinology, Polytechnic University of Marche, 60126, Ancona, Italy, m.boscaro@univpm.it.
J Bertherat
J Findling
M Fleseriu
A B Atkinson
S Petersenn
J Schopohl
P Snyder
G Hughes
A Trovato
K Hu
M Maldonado
B M K Biller
Novartis (Switzerland) · CHHôpital Cochin · FRLudwig-Maximilians-Universität München · DEMarche Polytechnic University · ITMassachusetts General Hospital · USMedical College of Wisconsin · USNovartis (United States) · USOregon Health & Science University · USPenn Center for AIDS Research · USRoyal Victoria Hospital · GBTris Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a previous 15-day, Phase II study of patients with de novo or persistent/recurrent Cushing's disease (core study), treatment with pasireotide 600 μg sc bid reduced urinary free cortisol (UFC) levels in 76% of patients and normalized UFC in 17%. The objective of this study was to evaluate the efficacy and safety of extended treatment with pasireotide. This was a planned, open-ended, single-arm, multicenter extension study (primary endpoint: 6 months). Patients aged ≥18 years with Cushing's disease who completed the core study could enter the extension if they achieved UFC normalization at core study end and/or obtained significant clinical benefit. Of the 38 patients who completed the core study, 19 entered the extension and 18 were included in the efficacy analyses (three responders, 11 reducers, four non-reducers in the core study). At data cut-off, median treatment duration in the extension was 9.7 months (range: 2 months to 4.8 years). At extension month 6, 56% of the 18 patients had lower UFC than at core baseline and 22% had normalized UFC. Of the four patients who remained on study drug at month 24, one had normalized UFC. Reductions in serum cortisol, plasma adrenocorticotropic hormone, body weight and diastolic blood pressure were observed. The most common adverse events were mild-to-moderate gastrointestinal disorders and hyperglycemia. Pasireotide offers a tumor-directed medical therapy that may be effective for the extended treatment of some patients with Cushing's disease.

Indexed as

Adrenocorticotropic HormoneAdultAgedFemaleHumansHydrocortisoneMaleMiddle AgedPituitary ACTH HypersecretionSomatostatinYoung AdultAdrenocorticotropic HormoneHydrocortisonepasireotideSomatostatin

Identifiers

PMID23943009
PMCPMC4085509
OpenAlexW2033180663

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.