BACKGROUND: We report the results of a phase IIB study investigating the safety and effectiveness of atorvastatin use with standard anti-TB drugs.METHODS: In this multicentre, open-labelled study, we recruited treatment-naÏve patients with uncomplicated pulmonary TB aged at least 18 years. Participants were randomly assigned to standard-of-care or standard-of-care plus oral dose of atorvastatin (40 mg) daily for 2 months. Primary end points were safety measured by the number of participants with severe adverse events and effectiveness measured by the number of participants with negative sputum culture. Secondary endpoint was chest X-ray (CXR) severity score.RESULTS: Of the 185 participants screened, 150 were enrolled and equally assigned to the standard-of-care and atorvastatin groups. Adverse event severity was similar in the two groups. There was increased frequency of muscle pain in the trial group (12/75, 16% vs. 4/75, 5%). For efficacy analysis, respectively 64 (97%) and 57 (85.1%) patients in the trial and control groups had culture-negative results (P = 0.02) and experienced a reduction in CXR severity score of respectively 37% and 22%, with a mean difference of 1.4-4.9%.CONCLUSION: Atorvastatin is safe and associated with improved microbiological and radiological outcomes in TB.