NEW YORK (Reuters Health) – A 12-month course of itraconazole was superior to a six-month course at reducing relapses of chronic pulmonary aspergillosis in a randomized controlled trial conducted in India.
“Preventing relapses and thereby further lung damage is a key objective in the management of chronic pulmonary aspergillosis,” write the UK-based authors of a comment published with the study in The Lancet Infectious Diseases.
“The results of this study are of great importance to provide evidence-based management guidance on how to prevent progressive lung damage and lung function decline in patients with chronic pulmonary aspergillosis,” add Dr. Adilia Warris of the University of Exeter and Dr. Darius Armstrong-James of Imperial College London.
The optimal duration of treatment for chronic pulmonary aspergillosis remains unclear, although most guidelines recommend a minimum of months of antifungal therapy for chronic pulmonary aspergillosis.
In an open-label trial, Dr. Inderpaul Sehgal and colleagues with the Postgraduate Institute of Medical Education and Research in Chandigarh randomly allocated 164 patients with chronic pulmonary aspergillosis to six or 12 months oral itraconazole (400 mg/day).
They found that the proportion of patients experiencing a relapse two years after starting treatment was significantly lower in the 12-month than six-month treatment group (10% vs. 38%), a significant difference.
The average time to first relapse was also significantly longer in the 12-month group (mean, 23 months vs. 18 months; P<0.0001).
Sixteen patients died, eight in each group.
There was no significant difference in the frequency of adverse events between the two study groups. Ten (12%) of 81 patients in the six-month group and 18 (22%) of 83 patients in the 12-month group had adverse effects, with none requiring treatment modification. Nausea and anorexia were the most common adverse events in both groups.
Based on the results, the researchers say “a revision of the current concept of treating chronic pulmonary aspergillosis with six months of oral itraconazole is warranted. Itraconazole should be given for at least 12 months for treatment of chronic pulmonary aspergillosis.”
The comment authors note that while several landmark randomized controlled trials have provided management guidelines for invasive pulmonary aspergillosis in patients who are neutropenic, robust data for chronic pulmonary aspergillosis are limited.
“The results from the study…will have important clinical implications, underpinning new evidence-based management guidelines,” they write.
The study had no funding and the authors have declared no conflicts of interest.
SOURCE: https://bit.ly/3rDkIcK and https://bit.ly/3xB2KLP Lancet Infectious Diseases, online April 13, 2022.
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