Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis

Ahmad, Nafees; Ahuja, Shama D.; Akkerman, Onno W.; Alffenaar, Jan‐Willem C.; Anderson, Laura; Baghaei, Parvaneh; Bang, Didi; Barry, Pennan M.; Bastos, Mayara Lisboa; Behera, Digamber; Benedetti, Andrea; Bisson, Gregory P.; Boeree, Martin J.; Bonnet, Maryline; Brode, Sarah K.; Brust, James C.M.; Cai, Ying; Caumes, Éric; Cegielski, J. Peter; Centis, Rosella; Chan, Pei-Chun; Chan, Edward D.; Chang, Kwok Chiu; Charles, Macarthur; Cīrule, Andra; Dalcolmo, Margareth Pretti; D’Ambrosio, Lia; Vries, Gerard de; Dheda, Keertan; Esmail, Aliasgar; Flood, Jennifer; Fox, Gregory J.; Fréchet-Jachym, Mathilde; Fregona, Geisa; Gayoso, Regina; Gegia, Medea; Gler, Maria Tarcela; Gu, Sue; Guglielmetti, Lorenzo; Holtz, Timothy H.; Hughes, Jennifer; Isaakidis, Petros; Jarlsberg, Leah G.; Kempker, Russell R.; Keshavjee, Salmaan; Khan, Faiz Ahmad; Kipiani, Maia; Koenig, Serena P.; Koh, Won‐Jung; Kritski, Afrânio Lineu; Kukša, Līga; Kvasnovsky, Charlotte; Kwak, Nakwon; Lan, Zhiyi; Lange, Christoph; Laniado-Laborı́n, Rafael; Lee, Myungsun; Leimane, Vaira; Leung, Chi‐Chiu; Leung, Eric Chung-Ching; Li, Pei Zhi; Lowenthal, Phil; Maciel, Ethel Leonor Nóia; Marks, Suzanne M.; Mase, Sundari; Mbuagbaw, Lawrence; Migliori, Giovanni Battista; Milanov, Vladimir; Miller, Ann C.; Mitnick, Carole D.; Modongo, Chawangwa; Mohr-Holland, Erika; Monedero, Ignacio; Nahid, Payam; Ndjeka, Norbert; O’Donnell, Max R; Padayatchi, Nesri; Palmero, Domingo; Pape, Jean William; Podewils, Laura Jean; Reynolds, Ian S.; Riekstiņa, Vija; Robert, Jérôme; Rodríguez, María Jesús; Seaworth, Barbara; Seung, Kwonjune J.; Schnippel, Kathryn; Shim, Tae Sun; Singla, Rupak; Smith, Sarah E.; Sotgiu, Giovanni; Sukhbaatar, Ganzaya; Tabarsi, Payam; Tiberi, Simon; Trajman, Anete; Trieu, Lisa; Udwadia, Zarir F; Werf, Tjip S van der; Véziris, Nicolas; Viiklepp, Piret; Vilbrun, Stalz Charles; Walsh, Kathleen F.; Westenhouse, Janice; Yew, Wing‐Wai; Yim, Jae Joon; Zetola, Nicola M.; Zignol, Matteo; Menzies, Dick

doi:10.1016/s0140-6736(18)31644-1

Cited by 494 publications

(434 citation statements)

References 71 publications

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“…These reviews are summarized in Table 8. All of these reviews conclude that linezolid is efficacious in the treatment of drug‐resistant tuberculosis, although authors comment on the high likelihood of adverse effects (Cox 2012; Sotgiu 2012; Chang 2013c; Zhang 2015; Ahmad 2018). Three reviews used studies as the unit of analysis, while two were individual patient data analyses.…”

Section: Discussionmentioning

confidence: 99%

“…In 2018, in a rapid communication from the WHO on treatment of MDR‐TB and rifampicin‐monoresistant‐TB, linezolid’s position was further upgraded to a ‘group A: Medicines to be prioritised' (WHO 2018). A summary of evidence for the 2018 recommendation has been published (Ahmad 2018). …”

Section: Introductionmentioning

confidence: 99%

“…Five meta‐analyses have examined the evidence for linezolid in drug‐resistant tuberculosis (Cox 2012; Sotgiu 2012; Chang 2013c; Zhang 2015; Ahmad 2018). They include mostly observational data, much of it retrospective.…”

Section: Introductionmentioning

confidence: 99%

“…There remains much debate surrounding linezolid, due to the lack of high‐quality evidence. Many suggest it should be more widely used, hence its upgrade in the recent WHO guidance (Caminero 2015; Ahmad 2018; WHO 2018). …”

Section: Introductionmentioning

confidence: 99%

“…Considerable reliance on retrospective data may have exacerbated the effect of confounders in the meta‐analyses of treatment efficacy (Cox 2012; Sotgiu 2012; Chang 2013c; Zhang 2015; Ahmad 2018). These reviews also selected, and focus on, efficacy rather than safety.…”

Section: Introductionmentioning

confidence: 99%

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Linezolid for drug-resistant pulmonary tuberculosis

Singh

Cocker

Ryan

et al. 2019

Cochrane Database of Systematic Reviews

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BackgroundLinezolid was recently re‐classified as a Group A drug by the World Health Organization (WHO) for treatment of multi‐drug resistant tuberculosis (MDR‐TB) and extensively drug‐resistant tuberculosis (XDR‐TB), suggesting that it should be included in the regimen for all patients unless contraindicated. Linezolid use carries a considerable risk of toxicity, with the optimal dose and duration remaining unclear. Current guidelines are mainly based on evidence from observational non‐comparative studies.ObjectivesTo assess the efficacy of linezolid when used as part of a second‐line regimen for treating people with MDR and XDR pulmonary tuberculosis, and to assess the prevalence and severity of adverse events associated with linezolid use in this patient group.Search methodsWe searched the following databases: the Cochrane Infectious Diseases Specialized Register; CENTRAL; MEDLINE; Embase; and LILACS up to 13 July 2018. We also checked article reference lists and contacted researchers in the field.Selection criteriaWe included studies in which some participants received linezolid, and others did not. We included randomized controlled trials (RCTs) of linezolid for MDR and XDR pulmonary tuberculosis to evaluate efficacy outcomes. We added non‐randomized cohort studies to evaluate adverse events.Primary outcomes were all‐cause and tuberculosis‐associated death, treatment failure, and cure. Secondary outcomes were treatment interrupted, treatment completed, and time to sputum culture conversion. We recorded frequency of all and serious adverse events, adverse events leading to drug discontinuation or dose reduction, and adverse events attributed to linezolid, particularly neuropathy, anaemia, and thrombocytopenia.Data collection and analysisTwo review authors (BS and DC) independently assessed the search results for eligibility and extracted data from included studies. All review authors assessed risk of bias using the Cochrane ‘Risk of bias' tool for RCTs and the ROBINS‐I tool for non‐randomized studies. We contacted study authors for clarification and additional data when necessary.We were unable to perform a meta‐analysis as one of the RCTs adopted a study design where participants in the study group received linezolid immediately and participants in the control group received linezolid after two months, and therefore there were no comparable data from this trial. We deemed meta‐analysis of non‐randomized study data inappropriate.Main resultsWe identified three RCTs for inclusion. One of these studies had serious problems with allocation of the study drug and placebo, so we could not analyse data for intervention effect from it. The remaining two RCTs recruited 104 participants. One randomized 65 participants to receive linezolid or not, in addition to a background regimen; the other randomized 39 participants to addition of linezolid to a background regimen immediately, or after a delay of two months. We included 14 non‐randomized cohort studies (two prospective, 12 retrospective), with a total of 1678 partici...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Linezolid for drug-resistant pulmonary tuberculosis

Singh

Cocker

Ryan

et al. 2019

Cochrane Database of Systematic Reviews

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Treatment Outcomes Among Pregnant Patients With Multidrug-Resistant Tuberculosis

et al. 2022

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Key Points Question What are the treatment outcomes and adverse events among pregnant patients with multidrug-resistant tuberculosis (MDR-TB)? Findings In a systematic review and meta-analysis of 10 studies including 275 pregnant patients with MDR-TB, the pooled proportion of treatment success was 72.5%, and the pooled proportion of favorable pregnancy outcomes was 73.2%. Adverse events, such as liver function impairment, kidney function impairment, hearing loss, and hypokalemia, were common among pregnant patients with MDR-TB, occurring in more than half of the patients. Meaning This study suggests that a high rate of treatment success and favorable pregnancy outcomes can be achieved when pregnant patients with MDR-TB are treated with effective regimens.

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Risk of Hepatocellular Carcinoma With Tenofovir vs Entecavir Treatment for Chronic Hepatitis B Virus

Tan

Tay

et al. 2022

JAMA Netw Open

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Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis

Abstract: American Thoracic Society, Canadian Institutes of Health Research, US Centers for Disease Control and Prevention, European Respiratory Society, Infectious Diseases Society of America.

Cited by 494 publications

References 71 publications

Linezolid for drug-resistant pulmonary tuberculosis

Linezolid for drug-resistant pulmonary tuberculosis

Treatment Outcomes Among Pregnant Patients With Multidrug-Resistant Tuberculosis

Risk of Hepatocellular Carcinoma With Tenofovir vs Entecavir Treatment for Chronic Hepatitis B Virus

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