Evidence map›Paper›PMID 26563167›Full record

SynthesisDigestive diseases and sciences2016

Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission.

Gary R Lichtenstein, Glenn L Gordon, Salam Zakko, Uma Murthy, Shahriar Sedghi, Ron Pruitt, Andrew C Barrett, Enoch Bortey, Craig Paterson, William P Forbes

3 registry-linked trialsOpen access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Digestive diseases and sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 22% 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.

NCT00326209 phase3completednot on this map

A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2005 to 2008Enrolled393ConditionsUlcerative ColitisArmsEncapsulated Mesalamine Granules (eMG)
NCT00744016 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2004 to 2007Enrolled305ConditionsUlcerative ColitisArmsGranulated mesalamine, Placebo
NCT00767728 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2004 to 2007Enrolled256ConditionsUlcerative ColitisArmsGranulated mesalamine, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Observational
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

10 authors at 5 institutions in 1 country.

Gary R LichtensteinDivision of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, 7th Floor Perelman Center, Room 753, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA. grl@uphs.upenn.edu.
Glenn L GordonCenter for Digestive and Liver Diseases, Mexico, MO, USA.
Salam ZakkoConnecticut Gastroenterology Institute and Clinical Research Foundation, Bristol, CT, USA.
Uma MurthySyracuse VA Medical Center, Syracuse, NY, USA.
Shahriar SedghiGastroenterology Associates of Central Georgia, LLC, Macon, GA, USA.
Ron PruittNashville Medical Research Institute, The Maria Nathanson Center at Saint Thomas Hospital, Nashville, TN, USA.
Andrew C BarrettSalix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
Enoch BorteySalix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
Craig PatersonSalix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
William P ForbesSalix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
Bausch Health (United States) · USCenter for Digestive and Liver Diseases · USHospital of the University of Pennsylvania · USNashville Medical Research Institute · USSUNY Upstate Medical University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults.

aimsEfficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission.

methodsData from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months.

resultsIncluded were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25-0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31-0.84; P = 0.009) that was sustained during the OLE.

conclusionsMG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. CLINICALTRIALS.GOV: NCT00744016, NCT00767728, and NCT00326209.

Indexed as

Adrenal Cortex HormonesAdultAnti-Inflammatory AgentsClinical Trials, Phase III as TopicColitis, UlcerativeDisease-Free SurvivalDrug Administration ScheduleFemaleGastrointestinal AgentsHumansMaleMesalamineMiddle AgedMulticenter Studies as TopicPowdersRandomized Controlled Trials as TopicAdrenal Cortex HormonesAnti-Inflammatory AgentsGastrointestinal AgentsMesalaminePowdersInflammatory bowel diseasesMesalamineRemissionSteroidsUlcerative colitis

Identifiers

PMID26563167
PMCPMC4700064
OpenAlexW2258798719

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.