Evidence map›Paper›PMID 41324792›Full record

ArticleAdvances in therapy2026

Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance.

Motoshi Wada, Shiro Nakamura, Ayako Hayashi, Rie Otake, Masakazu Miyamoto, Tomoko Tanaka

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05023382 (Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05023382 completednot on this map

Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)

TypeobservationalSponsorTakedaRan2021 to 2026Enrolled250ConditionsShort Bowel SyndromeArmsTeduglutide
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

6 authors.

Motoshi Wada *Department of Pediatric Surgery, Tohoku University Graduate School of Medicine, 1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan. wada@ped-surg.med.tohoku.ac.jp.ORCID 0000-0003-0413-4017
Shiro Nakamura *The Second Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Ayako HayashiJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Rie OtakeJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Masakazu MiyamotoMarketed Products Development JP, Clinical Science, Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Tomoko TanakaTherapeutic Area Strategy Unit GI and Inflammation, Takeda Pharmaceutical Company Limited, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with intestinal failure caused by short bowel syndrome (SBS) are dependent on parenteral support (PS) for nutrition. Teduglutide, an analogue of glucagon-like peptide 2, has been shown to decrease reliance on PS with an acceptable safety profile in multiregional phase 3 clinical trials, but currently there are no reports examining treatment outcomes with teduglutide in the real-world population in Japan. This interim analysis of a 36-month post-marketing surveillance (PMS) reports the safety and effectiveness of teduglutide in adults and pediatric patients with SBS in Japan.

methodsThis 6-month analysis was conducted as part of a prospective, all-case, 36-month PMS of teduglutide (Takeda Pharmaceutical Company Limited) conducted in patients with SBS across 102 sites in Japan. All patients who started teduglutide treatment from August 2021 to August 2022 were enrolled. Safety and effectiveness were evaluated after 6 months of teduglutide treatment and compared with baseline.

resultsA total of 123 patients aged 2-83 years were included in the safety analysis, including 27 children (aged < 15 years). A total of 51 patients (44 adults, 7 children) reported 117 adverse drug reactions (ADRs). In adults, the most common ADRs were abdominal distension (10.42%), abdominal pain (10.42%), stoma complication (8.33%), and nausea (7.29%). In children, the most common ADR was abdominal pain (11.11%). In the effectiveness analysis, 11.9% (12/101) of patients were able to wean off PS and 42.4% (39/92) were able to achieve at least 20% reduction in their PS volume. The overall mean (standard deviation) change from baseline in the z-score of body weight in children (n = 20) was 0.185 (0.2964).

conclusionIn this interim analysis of a 36-month PMS, teduglutide demonstrated an acceptable safety profile and promising effectiveness in patients with SBS.

trial registrationClinicalTrials.gov identifier, NCT05023382.

Indexed as

Gastrointestinal AgentsPeptidesShort Bowel SyndromeAdolescentAdultAgedAged, 80 and overChildChild, PreschoolFemaleHumansJapanMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesGastrointestinal AgentsPeptidesteduglutideCrohn’s diseaseInterim analysisJapanNutrition supportParenteral nutritionPost-marketing surveillanceReal-world evidenceSafetyShort bowel syndromeTeduglutide

Identifiers

PMID41324792
PMCPMC12858502

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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.