First-line tuberculosis treatment with double-dose rifampicin is well tolerated
| Autor: | Jozefien Buyze, M Gumusboga, Tom Decroo, D Arango, B. C. de Jong, Natacha Herssens, S Braet, C Schurmans, A. Van Deun, T Demeulenaere, Aung Kya Jai Maug, Wim Mulders, Lutgarde Lynen, M A Hossain |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine medicine.medical_specialty Tuberculosis 030106 microbiology Antitubercular Agents Article 03 medical and health sciences 0302 clinical medicine Internal medicine Isoniazid Humans Medicine 030212 general & internal medicine Adverse effect Tuberculosis Pulmonary Ethambutol Bangladesh business.industry Pyrazinamide medicine.disease Clinical trial Regimen Treatment Outcome Infectious Diseases Drug Therapy Combination Rifampin business Rifampicin medicine.drug |
| Zdroj: | Int J Tuberc Lung Dis |
| ISSN: | 1027-3719 |
| DOI: | 10.5588/ijtld.19.0063 |
| Popis: | OBJECTIVE: To compare the occurrence of unfavourable treatment and safety outcomes of double-dose rifampicin (RMP; 20 mg/kg/d, intervention) with standard dose (10 mg/kg/d, control) in a first-line tuberculosis (TB) treatment regimen for smear-positive TB patients in Bangladesh.DESIGN: This was a randomised clinical trial. The primary efficacy and safety endpoints were the occurrence of an unfavourable treatment outcome (death, failure, relapse or loss to follow-up) and the occurrence of any serious drug-related adverse event (SAE).RESULTS: In primary efficacy analysis, among 343 control and 347 intervention patients, respectively 15.5% and 11.8% had an unfavourable outcome. In safety analysis, among 349 intervention and 352 control patients, respectively 4.3% and 2.6% experienced an SAE. These differences were not significant. There was a significantly lower occurrence of SAEs, explained by a lower occurrence of hepatic toxicity, in a RMP double-dosed but erroneously HZE (isoniazid+pyrazinamide+ethambutol) under-dosed subgroup.CONCLUSIONS: Our findings show that there is no statistically significant difference in terms of efficacy and safety between standard and double-dose RMP. An accidental finding (related to dosage levels of the standard regimen) suggests that high-dose RMP is potentially a lesser cause of hepatotoxicity. Larger trials with more power, or trials with at least a triple-dose might be needed to clearly see the effect of high-dose RMP on unfavourable outcomes. |
| Databáze: | OpenAIRE |
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