Comparison of a four-drug fixed-dose combination regimen with a single tablet regimen in smear-positive pulmonary tuberculosis

International Journal of Tuberculosis and Lung Disease

Volumn 13, Issue 6, 2009, Pages 760-766

  Bartacek, A ^a   Schutt D ^a   Panosch, B ^b   Borek, M ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b Fokus KEG   (Austria)

Author keywords

Acceptability; Fixed dose combination; Pulmonary tuberculosis; Randomised trial; Smear conversion

Indexed keywords

ETHAMBUTOL; ISONIAZID; ISONIAZID PLUS RIFAMPICIN; PYRAZINAMIDE; RIFAMPICIN; RIMSTAR; UNCLASSIFIED DRUG;

ADULT; ARTHRALGIA; ARTHRITIS; ARTICLE; ASTHENIA; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL DISEASE; HEADACHE; HEPATITIS; HEPATOBILIARY DISEASE; HUMAN; JAUNDICE; LIVER DISEASE; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SKIN DISEASE; SPUTUM SMEAR; TREATMENT DURATION; TREATMENT OUTCOME; VOMITING;

ADULT; ANTITUBERCULAR AGENTS; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; ETHAMBUTOL; FEMALE; HUMANS; ISONIAZID; MALE; PATIENT SATISFACTION; PYRAZINAMIDE; RIFAMPIN; SPUTUM; TREATMENT OUTCOME; TUBERCULOSIS, PULMONARY;

EID: 67649202539     PISSN: 10273719     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (20)

1. Frieden T R, Sterling T R, Munsiff S S, Watt C J, Dye C. Tuberculosis. Lancet 2003; 362: 887-899.
2. Blomberg B, Spinaci S, Fourie B, Laing R. The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis. Bull World Health Organ 2001; 79: 61-68. (Pubitemid 32154097)
3. World Health Organization Tuberculosis Programme. Treatment of tuberculosis: guidelines for national programmes. 3rd ed. WHO/CDS/TB/2003.313. Geneva, Switzerland: WHO, 2003.
4. Blomberg B, Fourie B. Fixed-dose combination drugs for tuberculosis: application in standardised treatment regimens. Drugs 2003; 63: 535-553. (Pubitemid 36384620)
5. Blomberg B, Evans P, Phanouvong S, et al. Informal consultation on 4-drug fixed-dose combinations (4FDCs) compliant with the WHO Model List of Essential Drugs. WHO/CDS/TB/2002.299. Geneva, Switzerland: WHO, 2001.
6. Pildal J, Chan A W, Hrobjartsson A, Forfang E, Altman D G, Gotzsche P C. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ 2005; 330: 1049. (Pubitemid 40646553)
7. Schulz K F, Grimes D A. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002; 359: 614-618.
8. Schulz K F, Grimes D A. Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002; 359: 515-519.
9. World Health Organization. Laboratory services in tuberculosis control. Part II: microscopy. WHO/TB/98.258. Geneva, Switzerland: WHO, 1998.
10. World Health Organization, International Union Against Tuberculosis and Lung Disease, Royal Netherlands Tuberculosis Association. Revised international definitions in tuberculosis control. Int J Tuberc Lung Dis 2001; 5: 213-215.
11. Jindani A, Nunn A J, Enarson D A. Two 8-month regimens of chemotherapy for treatment of newly diagnosed pulmonary tuberculosis: international multicentre randomised trial. Lancet 2004; 364: 1244-1251. (Pubitemid 39311345)
12. Kumaresan J A, Ahsan Ali A K, Parkkali L M. Tuberculosis control in Bangladesh: success of the DOTS strategy. Int J Tuberc Lung Dis 1998; 2: 992-998. (Pubitemid 29005216)
13. Lienhardt C, Manneh K, Bouchier V, Lahai G, Milligan P J, McAdam K P. Factors determining the outcome of treatment of adult smear-positive tuberculosis cases in The Gambia. Int J Tuberc Lung Dis 1998; 2: 712-718. (Pubitemid 28429720)
14. Walley J D, Khan M A, Newell J N, Khan M H. Effectiveness of the direct observation component of DOTS for tuberculosis: a randomised controlled trial in Pakistan. Lancet 2001; 357: 664-669.
15. Faustini A, Hall A J, Perucci C A. Tuberculosis treatment outcomes in Europe: a systematic review. Eur Respir J 2005; 26: 503-510. (Pubitemid 41264216)
16. Smith C, Burley C, Ireson M, et al. Clinical trials of antibacterial agents: a practical guide to design and analysis. J Antimicrob Chemo 1998; 41: 467-480. (Pubitemid 28167506)
17. Lambert M L, Hasker E, Van Deun A, Roberfroid D, Boelaert M, Van der Stuyft P. Recurrence in tuberculosis: relapse or reinfection? Lancet Infect Dis 2003; 3: 282-287. (Pubitemid 36565879)
18. Forget E J, Menzies D. Adverse reactions to first-line antituberculosis drugs. Expert Opin Drug Saf 2006; 5: 231-249. (Pubitemid 43379622)
19. Gravendeel J M, Asapa A S, Becx-Bleumink M, Vrakking H A. Preliminary results of an operational field study to compare side-effects, complaints and treatment results of a single-drug short-course regimen with a four-drug fixed-dose combination (4FDC) regimen in South Sulawesi, Republic of Indonesia. Tuberculosis (Edinb) 2003; 83: 183-186. (Pubitemid 36683570)
20. Su W J, Perng R P. Fixed-dose combination chemotherapy (Rifater®/Rifinah®) for active pulmonary tuberculosis in Taiwan: a two-year follow-up. Int J Tuberc Lung Dis 2002; 6: 1029-1032. (Pubitemid 35408191)