Evidence map›Paper›PMID 42121320›Full record

SynthesisBritish journal of clinical pharmacology2026

Adverse events in bedaquiline- and pretomanid-based regimens for drug-resistant tuberculosis from trial, implementation and pharmacovigilance studies.

Nisa Maria, Annisa Lazuardi Larasati, Indri Yuliani Hamdani, Jin-Gun Cho, Jan-Willem C Alffenaar

Abstract readSystematic Review
In one paragraph

Synthesis in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

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

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

5 authors.

Nisa MariaSchool of Pharmacy, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.ORCID https://orcid.org/0000-0001-9075-8939
Annisa Lazuardi LarasatiFaculty of Pharmacy, Universitas Indonesia, Depok, Indonesia.ORCID https://orcid.org/0009-0005-5973-5946
Indri Yuliani HamdaniFaculty of Pharmacy, Universitas Indonesia, Depok, Indonesia.ORCID https://orcid.org/0009-0006-6394-9901
Jin-Gun ChoDepartment of Respiratory and Sleep Medicine, Westmead Hospital, Sydney, Australia.ORCID https://orcid.org/0000-0002-0735-4691
Jan-Willem C AlffenaarSchool of Pharmacy, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.ORCID https://orcid.org/0000-0001-6703-0288

Funding

Australia Awards
6 · The paper itself

Abstract

The availability of safety data, particularly concerning adverse events (AEs) associated with the new shorter regimen for drug-resistant tuberculosis (TB) containing a bedaquiline-pretomanid-based regimen, is still limited. This systematic review aims to provide a comprehensive and updated analysis of AEs related to this new regimen by combining safety data from clinical trials, implementation and pharmacovigilance studies. We conducted a search using PubMed, Medline and Web of Science to identify studies that reported AE data for bedaquiline-pretomanid-based regimens. In total, 14 studies from various countries were included in the analysis, comprising seven clinical trials, six implementation studies and one pharmacovigilance study. AE detection methods differed between clinical trials and implementation studies. Clinical trials utilised structured and standardised detection methods, whereas implementation and pharmacovigilance studies relied on spontaneous reporting with a higher prevalence of AEs reported in clinical trials (62.2-100%) compared to implementation studies (41.8-72.8%). Serious AEs developed in 2.2-30.2% of patients. Among those with serious AEs, 7.7-54.3% required interruption of TB drugs, while 3.5-13% required withdrawal of TB drugs. AE outcomes showed full recovery in 79.2%. However, 23-32% of patients reported AEs even after completing their treatment. Understanding AEs is crucial for healthcare professionals to enhance patient care, as early detection and appropriate management of AEs is essential in TB treatment to increase tolerability, minimise complications and optimise clinical outcomes. Further research is necessary to implement active monitoring for this new TB regimen in real-world settings.

Indexed as

Antitubercular AgentsDiarylquinolinesNitroimidazolesTuberculosis, Multidrug-ResistantClinical Trials as TopicDrug Therapy, CombinationHumansPharmacovigilanceAntitubercular AgentsbedaquilineDiarylquinolinesNitroimidazolespretomanidadverse eventsbedaquilinedrug‐resistant tuberculosispretomanid

Identifiers

PMID42121320
PMCPMC13420909

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.