Adverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials

Página do item simplificado
dc.contributor.authorCampbell, Jonathon R
dc.contributor.authorTrajman, Anete
dc.contributor.authorCook, Victoria J
dc.contributor.authorJohnston, James C
dc.contributor.authorAdjobimey, Menonli
dc.contributor.authorRuslami, Rovina
dc.contributor.authorEisenbeis, Lisa
dc.contributor.authorFregonese, Federica
dc.contributor.authorValiquette, Chantal
dc.contributor.authorBeneditti, Andrea
dc.contributor.authorMenzies, Dick
dc.date.accessioned2022-09-06T16:46:08Z
dc.date.available2022-09-06T16:46:08Z
dc.date.issued2020
dc.description.abstractBackground An important problem limiting treatment of latent tuberculosis infection is the occurrence of adverse events with isoniazid. We combined populations from phase 2 and phase 3 open-label, randomised controlled trials, to establish risk factors for adverse events during latent tuberculosis infection treatment. Methods We did a post-hoc safety analysis based on data from two open-label, randomised controlled trials done in health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea. Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to rifampicin or isoniazid. Patients were centrally randomly assigned 1:1 to 4 months of daily 10 mg/kg rifampicin or 9 months of daily 5 mg/kg isoniazid. The primary outcome evaluated was adverse events (including grade 1–2 rash and all events of grade 3–5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug by a masked, independent,three-member adjudication panel (trial registration: NCT00170209; NCT00931736). Findings Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3). The safety populations for each group comprised 3205 individuals receiving isoniazid and 280 receiving rifampicin. Among those receiving isoniazid, 86 (2·7%) of 3205 had grade 1–2 rash or any grade 3–5 adverse events, more than the 50 (1·5%) of 3280 who had these events with rifampicin (risk difference –1·2%, 95% CI –1·9 to –0·5). Age was associated with adverse events in adults receiving isoniazid. Compared with individuals aged 18–34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1–3·0) for individuals aged 35–64 years and 3·0 (1·2–6·8) for individuals aged 65–90 years. With rifampicin, adverse events were associated with inconsistent medication adherence (adjusted OR 2·0, 1·1–3·6) and concomitant medication use (2·8, 1·5–5·2), but not age, with an adjusted OR of 1·1 (0·6–2·1) for individuals aged 35–64 years and 1·7 (0·5–4·7) for individuals aged 65–90 years. One treatment-related death occurred in the isoniazid group. Interpretation In patients without a contraindication, rifampicin is likely to be the safest latent tuberculosis infection treatment option. With more widespread use of rifampicin, rare, but serious adverse events might be seen. However, within these randomised trials, rifampicin was safer than isoniazid and adverse events were not associated with older age. Therefore, rifampicin should become a primary treatment option for latent tuberculosis infection based on its safety.en
dc.identifier.citationCampbell JR, Trajman A, Cook V, Johnston JC, Adjobimey M, Ruslami R et al. Adverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials. Lancet Infect Dis. 2020;20: 318-29. Doi: 10.1016/S1473-3099(19)30575-4.
dc.identifier.otherDOI: 10.1016/S1473-3099(19)30575-4
dc.identifier.urihttps://dspace.inc.saude.gov.br/handle/123456789/219
dc.language.isoen
dc.publisherThe Lancet: Infectious Diseases
dc.subjectRifampicinapt
dc.subjectEnsaio clínico randomizadopt
dc.subjectTuberculose latentept
dc.subjectIsoniazidapt
dc.subjectRifampicinen
dc.subjectRandomised controlled trialen
dc.subjectLatent tuberculosisen
dc.subjectIsoniaziden
dc.subject.meshRisk Factorsen
dc.subject.meshRifampin / therapeutic useen
dc.subject.meshRifampin / adverse effectsen
dc.subject.meshRandomized Controlled Trials as Topicen
dc.subject.meshLatent Tuberculosis / drug therapyen
dc.subject.meshIsoniazid / therapeutic useen
dc.subject.meshIsoniazid / adverse effectsen
dc.subject.meshHumansen
dc.subject.meshDrug-Related Side Effects and Adverse Reactions / pathologyen
dc.subject.meshDrug-Related Side Effects and Adverse Reactions / epidemiologyen
dc.subject.meshClinical Trials, Phase III as Topicen
dc.subject.meshClinical Trials, Phase II as Topicen
dc.subject.meshAustraliaen
dc.subject.meshAsiaen
dc.subject.meshAntitubercular Agents / therapeutic useen
dc.subject.meshAntitubercular Agents / adverse effectsen
dc.subject.meshAmericasen
dc.subject.meshAfricaen
dc.subject.meshAdulten
dc.titleAdverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trialsen
dc.typeArticle
Arquivos
Original bundle
Agora exibindo 1 - 1 de 1
thumbnail.default.alt
Nome:
Campbell JR, Trajman A et al_2020.pdf
Tamanho:
1008.03 KB
Formato:
Adobe Portable Document Format
Descrição:
Baixar
License bundle
Agora exibindo 1 - 1 de 1
thumbnail.default.placeholder
Nome:
license.txt
Tamanho:
1.71 KB
Formato:
Item-specific license agreed to upon submission
Descrição:
Baixar
Coleções
Produção Bibliográfica
Produção Docente