Evidence map›Paper›PMID 36174745›Full record

ArticleChest2023

Sex Differences in TB Clinical Presentation, Drug Exposure, and Treatment Outcomes in India.

Sona Deshmukh, Manasi Sane, Sanjay Gaikwad, Tushar Sahasrabudhe, Madhusudan Barthwal, Rahul Lokhande, Swapnil Raskar, Anju Kagal, Sujata Dharmshale, Neeta Pradhan and 7 more

Open access · bronzeAbstract read
In one paragraph

Article in Chest, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 17% 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.

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

11 citing papers in PubMed, 15 citations in OpenAlex.

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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

17 authors at 5 institutions in 2 countries.

Sona DeshmukhByramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India; Johns Hopkins India, Pune, India.
Manasi SaneByramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India; Johns Hopkins India, Pune, India.
Sanjay GaikwadByramjee Jeejeebhoy Government Medical College, Pune, India.
Tushar SahasrabudheDr. D.Y. Patil Medical College, Hospital & Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune, India.
Madhusudan BarthwalDr. D.Y. Patil Medical College, Hospital & Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune, India.
Rahul LokhandeByramjee Jeejeebhoy Government Medical College, Pune, India.
Swapnil RaskarByramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India; Johns Hopkins India, Pune, India.
Anju KagalByramjee Jeejeebhoy Government Medical College, Pune, India.
Sujata DharmshaleByramjee Jeejeebhoy Government Medical College, Pune, India.
Neeta PradhanByramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India; Johns Hopkins India, Pune, India.
Akshay GupteJohns Hopkins University School of Medicine, Baltimore, MD.
Omamah AlfarisiJohns Hopkins University School of Medicine, Baltimore, MD.
Amita GuptaJohns Hopkins University School of Medicine, Baltimore, MD.
Kelly E DooleyJohns Hopkins University School of Medicine, Baltimore, MD.
Nikhil GupteByramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India; Johns Hopkins India, Pune, India; Johns Hopkins University School of Medicine, Baltimore, MD.
Jonathan E GolubDr. D.Y. Patil Medical College, Hospital & Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune, India.
Vidya MaveByramjee Jeejeebhoy Government Medical College-Johns Hopkins University Clinical Research Site, Pune, India; Johns Hopkins India, Pune, India; Johns Hopkins University School of Medicine, Baltimore, MD. Electronic address: vidyamave@gmail.com.
Johns Hopkins University · USGovernment Medical College · INDr. D. Y. Patil Medical College, Hospital and Research Centre · INJohns Hopkins Medicine · USDr. D.Y. Patil Vidyapeeth, Pune · IN

Funding

The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
The Impact of Diabetes on TB treatment outcomesR01AI097494 · NIAID · JOHNS HOPKINS UNIVERSITY · PI GOLUB, JONATHAN E. · 2013 to 2017
$3.0M
NIAID NIH HHS R01 AI097494NIAID NIH HHS UM1 AI069465
6 · The paper itself

Abstract

backgroundThe role of sex differences in clinical presentation, TB drug pharmacokinetic variables, and treatment outcomes is unclear. RESEARCH QUESTION: What is the effect of sex on TB disease severity, drug exposure, and treatment outcome? STUDY DESIGN AND

methodsThis study was a prospective cohort study conducted in India. It assessed TB disease severity; risk of unfavorable treatment outcomes (failure, recurrence, and death) according to sex; and risk factors for unfavorable outcomes stratified according to sex. Effects of sex on the pharmacokinetic variables (maximum concentration and area under the curve) of rifampicin, isoniazid, and pyrazinamide were estimated by using noncompartmental analyses.

resultsOf 1,541 people with microbiologically confirmed TB, 567 (37%) were women. Women had a lower risk of high mycobacterial burden (smear grade ≥ 2 and/or time to detection < 7 days) with an adjusted OR of 0.70 (95% CI, 0.56-0.87). Among the 744 participants who were followed up prospectively, 261 (35%) were women. Women had a lower risk of unfavorable treatment outcomes (adjusted incidence risk ratio, 0.60; 95% CI, 0.43-0.85), mostly because recurrence was lower (adjusted incidence risk ratio, 0.45; 95% CI, 0.23-0.86). Isoniazid (but not rifampicin and pyrazinamide) maximum concentration and area under the curve were significantly higher among women (P < .01) than men. Among women, unfavorable outcomes were more likely among those with cavitary disease, but among men, increased risk of unfavorable outcomes was associated with alcohol use, higher BMI, and lower glycated hemoglobin level.

interpretationWomen present with lower mycobacterial burden, achieve higher TB drug exposure, and are less likely to have unfavorable treatment outcomes than men. Strategies to improve TB treatment success should take into account sex differences in risk factors for unfavorable outcomes.

Indexed as

Antitubercular AgentsIsoniazidFemaleHumansIndiaMaleProspective StudiesPyrazinamideRifampinSex CharacteristicsTreatment OutcomeAntitubercular AgentsIsoniazidPyrazinamideRifampinclinical presentationdrug exposuremycobacterial burdensexTB treatment outcomes

Identifiers

PMID36174745
PMCPMC10258435
OpenAlexW4297141767

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.