Clofazimine is a safe and effective alternative for rifampicin in Mycobacterium avium complex pulmonary disease treatment - outcomes of a randomized trial

Chest. 2023 Nov 29:S0012-3692(23)05830-0. doi: 10.1016/j.chest.2023.11.038. Online ahead of print.ABSTRACTBACKGROUND: Retrospective studies have suggested clofazimine as an alternative for rifampicin in MAC-PD treatment.RESEARCH QUESTION: Is a treatment regimen consisting of clofazimine-ethambutol-macrolide non inferior to the standard treatment regimen (rifampicin-ethambutol-macrolide) in the treatment of M.avium complex pulmonary disease?STUDY DESIGN AND METHODS: In this single centre non-blinded clinical trial, we randomly assigned adult patients with MAC-PD in a 1:1 ratio to receive rifampicin or clofazimine as adjuncts to an ethambutol-macrolide backbone. The primary outcome was sputum culture conversion after six months of treatment.RESULTS: Forty patients were assigned to receive either rifampicin (n=19) or clofazimine (n=21) ) next to ethambutol and a macrolide. After 6 months of treatment, both arms showed similar percentages of sputum culture conversion based on intention to treat analysis: 58% (11/19) for rifampicin; 62% (13/21) for clofazimine. Study discontinuation, mainly due to adverse events, was equal in both arms (26% vs 33%). Based on an on treatment analysis sputum culture conversion after 6 months of treatment was 79% in both groups. In the clofazimine arm, diarrhoea was more prevalent (76% vs 37%; p=0.012), while arthralgia was more frequent in the rifampicin arm (37% vs 5%; p=0.011). No difference in the frequency of QTc prolongation was seen between bo...
Source: Chest - Category: Respiratory Medicine Authors: Source Type: research