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SETTING:Patients with newly-diagnosed drug-sensitive, radiographically active and bacteriologically confirmed pulmonary tuberculosis recruited at 6 centres in Argentina, Brazil and Thailand. OBJECTIVE:To assess the efficacy, tolerability and toxicity of two regimens containing different daily dosages of rifabutin in comparison with rifampicin. DESIGN:Multicentred, randomised, comparative study. In each group, study medications were administered daily for 6 months combined with isoniazid (6 months), and with pyrazinamide and ethambutol (both stopped after 2 months). Treatment success patients were followed-up for up to 2 years. RESULTS:A total of 520 patients were enrolled and randomly assigned to receive either rifampicin (n = 175), or rifabutin 150 mg (n = 174) or rifabutin 300 mg (n = 171). Considering all patients with positive baseline culture, the success rates at the last valid observation for each patient were 89%, 94% and 92% in the rifampicin, rifabutin 150 mg, and rifabutin 300 mg groups, respectively. The median time to culture conversion was comparable in the 3 groups and was 34 days for rifampicin and 37 days for each of the rifabutin groups. During the drug-free follow-up period, one relapse occurred in the rifampicin group, and two in each of the rifabutin groups. The 3 treatment schedules appeared well tolerated. No patients had to discontinue therapy because of an adverse event in the rifabutin 150 mg group, compared to one in the rifampicin and 5 in the rifabutin 300 mg group. CONCLUSION:All 3 regimens proved effective and well tolerated. Rifabutin at 150 mg/d showed the best risk-to-benefit ratio, in that this group had the highest proportion of patients completing treatment, the highest bacteriological conversion rates and the lowest incidence of adverse events.

Original publication

DOI

10.1016/0962-8479(94)90079-5

Type

Journal article

Journal

Tubercle and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease

Publication Date

10/1994

Volume

75

Pages

341 - 347

Addresses

Division of Phthisiopneumonology, Hospital Muñiz, Buenos Aires, Argentina.

Keywords

Sputum, Humans, Mycobacterium tuberculosis, Tuberculosis, Pulmonary, Rifabutin, Rifampin, Follow-Up Studies, Drug Resistance, Microbial, Dose-Response Relationship, Drug, Adolescent, Adult, Aged, Middle Aged, Female, Male