12-months oral itraconazole most optimal for prevention of relapse of chronic pulmonary aspergillosis: Lancet
Chandigarh, India: 12 months of treatment with oral itraconazole in patients with chronic pulmonary aspergillosis is superior to 6 months of oral itraconazole with regards to reducing relapses at 2 years, reveals a recent study. The findings, published in The Lancet Infectious Diseases, indicate that for treating chronic pulmonary aspergillosis itraconazole should be given for at least 12 months.
Globally, 5-year mortality of chronic pulmonary aspergillosis is 50–80%, and there is no clarity on the optimal duration of chronic pulmonary aspergillosis treatment. Considering this, Inderpaul S Sehgal from Postgraduate Institute of Medical Education and Research, Chandigarh, India, and colleagues aimed to compare the effect of 6-months of oral itraconazole with 12-months of oral itraconazole on chronic pulmonary aspergillosis clinical outcomes in a single-centre, open-label, randomised controlled trial.
The trial was conducted in one chest clinic in Chandigarh, India in which consecutive patients with chronic pulmonary aspergillosis who were naive to antifungal treatment were screened. They were randomized to receive a starting dose of 400 mg/day of oral itraconazole for either 6 months or 12 months. Patients who were unable to provide informed consent; had an intake of any antifungal drugs for more than 3 weeks in the preceding 6 months; had allergic, subacute, or invasive forms of aspergillosis; and had active Mycobacterium tuberculosis or non-tuberculous mycobacterial pulmonary disease were excluded.
The proportion of patients having relapse 2 years after treatment initiation was the primary outcome. An intention-to-treat analysis was performed for all outcomes.
Of 164 patients included in the trial, 81 patients were randomised to the 6-month group and 83 patients were randomised to the 12-month group. The study population was 48% women and 52% men, and the mean age of participants was 44·3 years.
The study revealed the following findings:
- The proportion of patients experiencing relapse was significantly lower in the 12-month group, 38% had a relapse in the 6-month group compared with 10% in the 12-month group, with an absolute risk reduction of 0.29.
- The mean time to first relapse was 23 months in the 12-month group, which is significantly longer than the mean of 18 months in the 6-month group.
- There were 16 deaths in total, eight in each group.
- Ten (12%) of 81 patients in the 6-months group and 18 (22%) of 83 patients in the 12-months group had adverse effects, with none requiring treatment modification. Nausea and anorexia were the most common adverse events in both groups.
The findings led to the conclusion that treatment of chronic pulmonary aspergillosis with 12 months of oral itraconazole was superior to 6 months of oral itraconazole in reducing relapses at 2 years.
The researchers conclude, "itraconazole should be given for at least 12 months for treating chronic pulmonary aspergillosis."
Reference:
The study titled, "Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India," was published in The Lancet Infectious Diseases.
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