PET-CT outcomes from a randomised controlled trial of rosuvastatin as an adjunct to standard tuberculosis treatment

Gail B. Cross (), Intan P. Sari, Sarah M. Burkill, Chee Woei Yap, Han Nguyen, Do Quyet, Victoria B. Dalay, Emmanuel Gutierrez, Vincent M. Balanag, Randy J. Castillo, Christina C. Chang, Anthony D. Kelleher, Jim O’Doherty and Nicholas I. Paton
Additional contact information
Gail B. Cross: Department of Medicine
Intan P. Sari: Department of Medicine
Sarah M. Burkill: Singapore Clinical Research Institute
Chee Woei Yap: Department of Diagnostic Imaging
Han Nguyen: Respiratory Medicine
Do Quyet: Respiratory Medicine
Victoria B. Dalay: De La Salle Medical and Health Sciences Institute
Emmanuel Gutierrez: De La Salle Medical and Health Sciences Institute
Vincent M. Balanag: Lung Centre of the Philippines
Randy J. Castillo: Lung Centre of the Philippines
Christina C. Chang: Central Clinical School
Anthony D. Kelleher: University of New South Wales
Jim O’Doherty: Clinical Imaging Research Centre
Nicholas I. Paton: Department of Medicine

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract Adjunctive rosuvastatin for rifampicin-susceptible pulmonary tuberculosis (rs-PTB) shows no effect on microbiological or radiological outcomes in a phase IIb randomised, controlled trial (NCT04504851). We explore the impact of adjunctive rosuvastatin on 18F-fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) imaging in a sub-study of 24 participants. Changes in standardised uptake value (SUVmax, SUVmean), Total Metabolic Volume, (TMV), Total Lesion Glycolysis (TLG), cavity diameter and volume, between week 0 and week 8 post-randomisation, are evaluated. Here we show no evidence of difference in the reduction in TLG [median 65.8% for the rosuvastatin group (Q1, Q3 38.6, 94.5) vs 64.3% for standard tuberculosis treatment group (Q1, Q3 −20.0, 81.7), P = 0.32], reduction in cavity volume on CT [median 3.2 cm3 (IQR 11.1, 0.5) for rosuvastatin, 2.2 cm3 (IQR 4.6, 0.7) for control (p = 0.72)], or any other PET-CT parameter measured. We show that the first 8-weeks of standard tuberculosis treatment results in a reduction in the volumetric indices (TLG and TMV), but had little change in SUVmax or SUVmean. Change in TLG and TMV holds promise as biomarkers of tuberculosis treatment response: future PET-CT studies should evaluate their role in predicting relapse-free cure, and the overall role of 18F-FDG-PET-CT as a tool for early-phase tuberculosis clinical trials.

Date: 2024
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DOI: 10.1038/s41467-024-54419-3

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