Evidence map›Paper›PMID 31440946›Full record

Trial reportPituitary2019

Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study.

Luca Manetti, Timo Deutschbein, Jochen Schopohl, Kevin C J Yuen, Michael Roughton, Ulrike Kriemler-Krahn, Libuse Tauchmanova, Ricardo Maamari, Carla Giordano

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pituitary, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02310269 (Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

NCT02310269 completednot on this map

Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)

TypeobservationalSponsorRECORDATI GROUPRan2013 to 2023Enrolled152ConditionsCushings DiseaseArmsPasireotide
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Glucocorticoid excess and COVID-19 disease.Reviews in endocrine & metabolic disorders · 2021
    Review
  9. 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.

Luca ManettiAzienda Ospedaliero-Universitaria Pisana, Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa, UO Endocrinologia 2 Ospedale Cisanello Via Paradisa 2, 56124, Pisa, Italy. l.manetti@ao-pisa.toscana.it.ORCID http://orcid.org/0000-0001-9911-5366
Timo DeutschbeinDivision of Endocrinology and Diabetes, Department of Internal Medicine I, University Hospital, University of Würzburg, Würzburg, Germany.
Jochen SchopohlMedizinische Klinik und Poliklinik IV, Ludwig-Maximilians-Universität München, Munich, Germany.
Kevin C J YuenSwedish Pituitary Center, Swedish Neuroscience Institute, Seattle, WA, USA.
Michael RoughtonNovartis Pharma AG, Basel, Switzerland.
Ulrike Kriemler-KrahnNovartis Pharma AG, Basel, Switzerland.
Libuse TauchmanovaNovartis Pharma AG, Basel, Switzerland.
Ricardo MaamariNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Carla GiordanoSection of Endocrinology, Diabetology and Metabolism, Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialities (PROMISE), University of Palermo, Palermo, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeClinical trials have demonstrated the favorable efficacy/safety profile of pasireotide in patients with Cushing's disease (CD). We report interim long-term results of an ongoing real-world evidence study of subcutaneous pasireotide in patients with CD.

methodsAdults with CD receiving pasireotide, initiated before (prior-use) or at study entry (new-use), were monitored for ≤ 3 years during a multicenter observational study ( http://clinicaltrials.gov identifier NCT02310269). Primary objective was to assess long-term safety of pasireotide alone or with other CD therapies.

resultsAt the time of this interim analysis, 127 patients had received pasireotide (new-use, n = 31; prior-use, n = 96). Eight patients had completed the 3-year observation period, 53 were ongoing, and 66 had discontinued. Among 31 new-use and 92 prior-use patients with ≥ 1 safety assessment, respectively: 24 (77%) and 37 (40%) had drug-related adverse events (AEs); 7 (23%) and 10 (11%) had serious drug-related AEs. Most common drug-related AEs were nausea (14%), hyperglycemia (11%) and diarrhea (11%); these were more frequently reported in new users and mostly of mild-to-moderate severity. 14 (45%) new-use and 15 (16%) prior-use patients experienced hyperglycemia-related AEs. Mean urinary free cortisol (mUFC) was within normal range at baseline and months 1, 12 and 24, respectively, in: 1/16 (6%), 9/18 (50%), 1/3 (33%) and 0/0 new users; 28/43 (65%), 15/27 (56%), 27/33 (82%) and 12/19 (63%) prior users.

conclusionsPasireotide is well tolerated and provides sustained reductions in mUFC during real-world treatment of CD. The lower rate of hyperglycemia-related AEs in prior users suggests that hyperglycemia tends not to deteriorate if effectively managed soon after onset. CLINICAL TRIAL REGISTRATION NUMBER: NCT02310269.

Indexed as

AdultFemaleHumansHyperglycemiaMaleMiddle AgedMulticenter Studies as TopicPituitary ACTH HypersecretionSomatostatinTreatment OutcomepasireotideSomatostatinCushing’s diseaseHypercortisolismPasireotidePituitarySafety

Identifiers

PMID31440946
PMCPMC6728293

What OpenQuestion holds

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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 OpenQuestion graph.