Document Detail

Comparison of a four-drug fixed-dose combination regimen with a single tablet regimen in smear-positive pulmonary tuberculosis.
MedLine Citation:
PMID:  19460254     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To compare the efficacy, safety and acceptability of two short-course regimens of isoniazid, rifampicin, pyrazinamide and ethambutol (HRZE) given either as fixed-dose combination (4-FDC) tablets or as single tablets (ST) in patients with newly diagnosed pulmonary tuberculosis (PTB). DESIGN: This randomised, open, multicentre, multinational study was conducted in 26 centres and included 1159 patients with smear-positive PTB. 4-FDC daily for 2 months then H+R for 4 months, or single preparations of H, R, Z and E for 2 months followed by H and R for 4 months were administered daily. Sputum smear conversion rates at 2, 4 and 6 months (end of treatment [EOT], primary endpoint) and at 9 and 12 months (follow-up) were measured, together with adverse events and the acceptability of the formulations. RESULTS: Smear conversion rates for 4-FDC and ST at EOT were 80.4% (468/582 patients) vs. 82.7% (477/577) in the intent-to-treat (ITT) population, and 98.1% (404/412) vs. 98.6% (416/422) in the per-protocol (PP) subgroup. Non-inferiority of 4-FDC was demonstrated at month 2, EOT and follow-up in both the ITT and the PP populations. Overall numbers of adverse events were not significantly different between the groups. CONCLUSION: The efficacy of the 4-FDC regimen was non-inferior to that of the ST regimens, but patient acceptability significantly improved with 4-FDC.
A Bartacek; D Schütt; B Panosch; M Borek;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease     Volume:  13     ISSN:  1027-3719     ISO Abbreviation:  Int. J. Tuberc. Lung Dis.     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-05-22     Completed Date:  2009-07-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9706389     Medline TA:  Int J Tuberc Lung Dis     Country:  France    
Other Details:
Languages:  eng     Pagination:  760-6     Citation Subset:  IM    
Sandoz GmbH, Kundl, Austria.
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MeSH Terms
Antitubercular Agents / administration & dosage*
Drug Combinations
Drug Therapy, Combination
Ethambutol / administration & dosage
Isoniazid / administration & dosage
Patient Satisfaction
Pyrazinamide / administration & dosage
Rifampin / administration & dosage
Sputum / drug effects
Treatment Outcome
Tuberculosis, Pulmonary / diagnosis,  drug therapy*
Reg. No./Substance:
0/Antitubercular Agents; 0/Drug Combinations; 13292-46-1/Rifampin; 54-85-3/Isoniazid; 74-55-5/Ethambutol; 98-96-4/Pyrazinamide
M Abdel Mageed / ; E Assam / ; S Fayed / ; A Hibachi / ; J N Banvaliker / ; A G Ghoshal / ; K Jagannath / ; S K Katiyar / ; K J R Murthy / ; S K Rajan / ; S Khurshid-uz-Zaman / ; N Rizvi / ; A Sadique / ; T Aquino / ; T Atienza / ; D Diaz / ; L Fernandez / ; N Francisco / ; G Isidro / ; M Jorge / ; G Lim / ; P Magalit / ; S Naval / ; T Pollosa / ; C Roa / ; A Santos / ; G Solante / ; D Tan / ; J Young / ; E Yu / ; S Arkasilp / ; A Cheepsattaykorn / ; C Chuchottaworn / ; Y Kasetcharoen / ; K Pannachej / ; N Tesana /

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