Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment
OBJECTIVES: Fixed-dose combination formulations, which simplify the administration of drugs and prevent the development of drug resistance, have been recommended as a standard anti-tuberculosis treatment regimen. However, the composition and dosage recommendations for fixed-dose combination formulat...
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| Format: | Article |
| Language: | English |
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Elsevier España
2015-06-01
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| Series: | Clinics |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322015000600429&lng=en&tlng=en |
| _version_ | 1818232762265501696 |
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| author | Jiun-Ting Wu Chien-Tung Chiu Yu-Feng Wei Yung-Fa Lai |
| author_facet | Jiun-Ting Wu Chien-Tung Chiu Yu-Feng Wei Yung-Fa Lai |
| author_sort | Jiun-Ting Wu |
| collection | DOAJ |
| description | OBJECTIVES: Fixed-dose combination formulations, which simplify the administration of drugs and prevent the development of drug resistance, have been recommended as a standard anti-tuberculosis treatment regimen. However, the composition and dosage recommendations for fixed-dose combination formulations differ from those for separate formulations. Thus, questions about the effectiveness and side effects of combination formulations remain. The aim of this study was to compare the safety and efficacy of these two types of anti-tuberculosis regimens for pulmonary tuberculosis treatment. METHOD: A prospective, randomized controlled study was conducted using the directly observed treatment short-course strategy. Patients were randomly allocated to one of two short-course regimens. One year after completing the treatment, these patients’ outcomes were analyzed. ClinicalTrials.gov: NCT00979290. RESULTS: A total of 161 patients were enrolled, 142 of whom were evaluable for safety assessment. The two regimens had a similar incidence of adverse effects. In the per-protocol population, serum bilirubin concentrations at the peak level, at week 4, and at week 8 were significantly higher for the fixed-dose combination formulation than for the separate formulations. All patients had negative sputum cultures at the end of the treatment, and no relapse occurred after one year of follow-up. CONCLUSIONS: In this randomized study, transient higher serum bilirubin levels were noted for the fixed-dose combination regimen compared with the separate formulations during treatment. However, no significant difference in safety or efficacy was found between the groups when the directly observed treatment short-course strategy was used. |
| first_indexed | 2024-12-12T11:11:26Z |
| format | Article |
| id | doaj.art-45b35f709cfc4386acff485499f618ca |
| institution | Directory Open Access Journal |
| issn | 1980-5322 |
| language | English |
| last_indexed | 2024-12-12T11:11:26Z |
| publishDate | 2015-06-01 |
| publisher | Elsevier España |
| record_format | Article |
| series | Clinics |
| spelling | doaj.art-45b35f709cfc4386acff485499f618ca2022-12-22T00:26:16ZengElsevier EspañaClinics1980-53222015-06-0170642943410.6061/clinics/2015(06)08S1807-59322015000600429Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatmentJiun-Ting WuChien-Tung ChiuYu-Feng WeiYung-Fa LaiOBJECTIVES: Fixed-dose combination formulations, which simplify the administration of drugs and prevent the development of drug resistance, have been recommended as a standard anti-tuberculosis treatment regimen. However, the composition and dosage recommendations for fixed-dose combination formulations differ from those for separate formulations. Thus, questions about the effectiveness and side effects of combination formulations remain. The aim of this study was to compare the safety and efficacy of these two types of anti-tuberculosis regimens for pulmonary tuberculosis treatment. METHOD: A prospective, randomized controlled study was conducted using the directly observed treatment short-course strategy. Patients were randomly allocated to one of two short-course regimens. One year after completing the treatment, these patients’ outcomes were analyzed. ClinicalTrials.gov: NCT00979290. RESULTS: A total of 161 patients were enrolled, 142 of whom were evaluable for safety assessment. The two regimens had a similar incidence of adverse effects. In the per-protocol population, serum bilirubin concentrations at the peak level, at week 4, and at week 8 were significantly higher for the fixed-dose combination formulation than for the separate formulations. All patients had negative sputum cultures at the end of the treatment, and no relapse occurred after one year of follow-up. CONCLUSIONS: In this randomized study, transient higher serum bilirubin levels were noted for the fixed-dose combination regimen compared with the separate formulations during treatment. However, no significant difference in safety or efficacy was found between the groups when the directly observed treatment short-course strategy was used.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322015000600429&lng=en&tlng=enPulmonary TuberculosisFixed-Dose CombinationAdverse EffectEfficacy |
| spellingShingle | Jiun-Ting Wu Chien-Tung Chiu Yu-Feng Wei Yung-Fa Lai Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment Clinics Pulmonary Tuberculosis Fixed-Dose Combination Adverse Effect Efficacy |
| title | Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment |
| title_full | Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment |
| title_fullStr | Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment |
| title_full_unstemmed | Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment |
| title_short | Comparison of the safety and efficacy of a fixed-dose combination regimen and separate formulations for pulmonary tuberculosis treatment |
| title_sort | comparison of the safety and efficacy of a fixed dose combination regimen and separate formulations for pulmonary tuberculosis treatment |
| topic | Pulmonary Tuberculosis Fixed-Dose Combination Adverse Effect Efficacy |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322015000600429&lng=en&tlng=en |
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