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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Adverse events with 4 months of rifampin therapy or 9 months of isoniazid therapy for latent tuberculosis infection: A randomized trial
Annals of Internal Medicine, Volume 149, No. 10, Year 2008
Notification
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Description
Background: Treatment of latent tuberculosis infection with isoniazid for 9 months is complicated by poor patient adherence and the need for close follow-up of side effects, especially hepatotoxicity. Shorter and safer regimens are needed. Objective: To compare the frequency of adverse events and treatment completion in 2 treatment regimens for latent tuberculosis infection. Design: Multicenter, randomized, open-label trial. Setting: Tuberculosis clinics located in university hospitals in Canada, Brazil, and Saudi Arabia. Patients: 847 patients without a contraindication for rifampin and requiring treatment for latent tuberculosis infection. Intervention: Four months of daily rifampin therapy or 9 months of daily isoniazid therapy. Measurements: Grade 3 to 4 drug-related adverse events resulting in drug discontinuation (primary outcome), and on-time treatment completion, grade 1 to 2 drug-related adverse events, and changes in liver enzymes and hematologic variables (secondary outcomes). Results: Seventeen of 422 participants who started isoniazid therapy developed grade 3 to 4 adverse events compared with 7 of 418 who started rifampin therapy (risk difference [rifampin minus isoniazid], -2.3% [95% CI, -5% to -0.1%]; P = 0.040). Grade 3 or 4 hepatitis occurred in 16 of 422 isoniazid recipients compared with 3 of 418 rifampin recipients (risk difference, -3.1% [CI, -5% to -1%]; P = 0.003). Grade 1 or 2 adverse events attributed to study drugs occurred with similar frequency. Asymptomatic reduction in platelet and leukocyte counts were more frequent in rifampin recipients. More patients completed rifampin treatment (78%) than isoniazid treatment (60%) (difference, 18% [CI, 12% to 24%]; P < 0.001]). Limitation: The study did not measure efficacy, and the open-label design may increase the chance of bias in ascertainment of adverse events. Conclusion: Treatment of latent tuberculosis with 4 months of rifampin leads to fewer serious adverse events and better adherence than 9 months of isoniazid. These findings justify a large-scale trial to compare the efficacy of rifampin with that of isoniazid. © 2008 American College of Physicians.
Authors & Co-Authors
Richard (Dick), Menzies
Canada, Montreal
Mcgill University Health Centre, Montreal Chest Institute
Long, Richard L.
Canada, Edmonton
Aberhart Hospital
Trajman, Anete
Unknown Affiliation
Dion, M. J.
Canada, Montreal
Mcgill University Health Centre, Montreal Chest Institute
Yang, Jae
Canada, Toronto
Saint Michael's Hospital University of Toronto
Al-Jahdali, Hamdan H.
Saudi Arabia, Riyadh
King Abdulaziz Medical City - Riyadh
Al Memish, Ziad Ahmed
Saudi Arabia, Riyadh
King Abdulaziz Medical City - Riyadh
Khan, Kamran M.
Canada, Toronto
Li ka Shing Knowledge Institute
Gardam, Michael A.
Canada, Toronto
University Health Network University of Toronto
Hoeppner, V.
Canada, Saskatoon
Royal University Hospital
Benedetti, Andrea L.
Canada, Montreal
Mcgill University Health Centre, Montreal Chest Institute
Schwartzman, Kevin J.
Canada, Montreal
Mcgill University Health Centre, Montreal Chest Institute
Statistics
Citations: 207
Authors: 12
Affiliations: 7
Identifiers
Doi:
10.7326/0003-4819-149-10-200811180-00003
ISSN:
00034819
e-ISSN:
15393704
Research Areas
Health System And Policy
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study