Evidence map›Paper›PMID 26094251›Full record

SynthesisJournal of Crohn's & colitis2015

Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative Colitis: A Pooled Safety Analysis.

Gary R Lichtenstein, Simon Travis, Silvio Danese, Geert D'Haens, Luigi Moro, Richard Jones, Michael Huang, E David Ballard, Robert Bagin, Yun Hardiman and 2 more

Registry-linked trialAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of Crohn's & colitis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03315052 (Budesonide in Liver Transplantation), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
–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.

NCT03315052 phase4withdrawnnot on this mapstarted 2019, after this paper: background citation

Budesonide in Liver Transplantation

TypeinterventionalSponsorMontefiore Medical CenterRan2019 to 2022Enrolled0ConditionsAcute Cellular Graft Rejection, Liver Transplant RejectionArmsBudesonide, Tacrolimus（FK506）, Mycophenolate Mofetil, Prednisone
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Methylation-Regulated Long Non-Coding RNA Expression in Ulcerative Colitis.International journal of molecular sciences · 2023
    Article
  6. Clinical characteristics of ulcerative colitis in elderly patients.JGH open : an open access journal of gastroenterology and hepatology · 2021
    Review
  7. Review
  8. Review
  9. Article
  10. Observational
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Budesonide for the treatment of ulcerative colitis.Expert opinion on pharmacotherapy · 2016
    Review
  19. 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

12 authors.

Gary R LichtensteinDivision of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA grl@uphs.upenn.edu.
Simon TravisTranslational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK.
Silvio DaneseInstituto Clinico Humanitas, Milan, Italy.
Geert D'HaensAcademic Medical Center, Amsterdam, The Netherlands.
Luigi MoroCosmo Technologies Ltd, Dublin, Ireland.
Richard JonesCosmo Technologies Ltd, Dublin, Ireland.
Michael HuangSantarus, Inc., San Diego, CA, USA.
E David BallardSantarus, Inc., San Diego, CA, USA.
Robert BaginSantarus, Inc., San Diego, CA, USA.
Yun HardimanSantarus, Inc., San Diego, CA, USA.
Raul CollazoSantarus, Inc., San Diego, CA, USA.
William J SandbornUniversity of California San Diego, La Jolla, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsCumulative safety and tolerability of budesonide MMX, a once-daily oral corticosteroid for inducing mild to moderate ulcerative colitis remission, was examined.

methodsData from three randomized, double-blind, placebo-controlled, phase II or III studies [budesonide MMX 9 mg, 6 mg, or 3mg for 8 weeks]; one phase II study [randomisation to budesonide MMX 9 mg or placebo for 4 weeks, then open-label budesonide MMX 9 mg for 4 weeks]; and one open-label study [budesonide MMX 9 mg for 8 weeks] were pooled.

resultsPatients randomised to budesonide MMX 9 mg [n = 288], 6 mg [n = 254], or placebo [n = 293] had similar rates of adverse events [AEs] [27.1%, 24.8%, and 23.9%, respectively] and serious AEs [2.4%, 2.0%, and 2.7%, respectively]; treatment-related AEs and serious AEs were reported by 11.8% and 13.5%, and 5.9% and 2.2%, respectively, of patients receiving budesonide MMX 3mg [n = 17] or open-label budesonide MMX 9 mg [n = 89]. Mean morning plasma cortisol concentrations were normal from baseline to final visit across randomised groups; in patients receiving open-label budesonide, mean cortisol concentration was 129.9 nmol/l after 4 weeks, returning to normal concentrations at final visit. Budesonide MMX was not associated with an overall increased risk for glucocorticoid-related adverse effects.

conclusionsBudesonide MMX 9 mg was associated with normal mean cortisol concentrations at final visit and an AE incidence comparable to placebo. Overall, budesonide MMX was safe and well tolerated for inducing remission of patients with mild to moderate ulcerative colitis.

Indexed as

Induction ChemotherapyAdministration, OralAdolescentAdultAgedAged, 80 and overAnti-Inflammatory AgentsBiomarkersBudesonideColitis, UlcerativeDrug Administration ScheduleDrug MonitoringFemaleHumansHydrocortisoneMaleAnti-Inflammatory AgentsBiomarkersBudesonideHydrocortisoneBudesonide MMXsafetytolerabilityulcerative colitis

Identifiers

PMID26094251
PMCPMC4736820

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.