FRIDAY, May 3, 2019 (Pharmacist's Briefing) -- Three months of azithromycin did not significantly reduce treatment failure (TF) among patients hospitalized for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD), according to a study published online May 3 in the American Journal of Respiratory and Critical Care Medicine.
Kristina Vermeersch, from KU Leuven in Belgium, and colleagues conducted a multicenter, randomized trial involving patients hospitalized for an AECOPD with a smoking history of ≥10 pack-years and at least one exacerbation in the previous year. In total, 301 patients were randomly assigned within 48 hours of admission to receive either azithromycin or placebo (147 and 154, respectively) administered for three days. Patients also received standardized acute treatment of systemic corticosteroids and antibiotics. They continued treatment for three months.
The researchers found that the TF rate within three months was 49 and 60 percent in the azithromycin and placebo groups, respectively (hazard ratio [HR], 0.73; 95 percent confidence interval [CI], 0.53 to 1.01; P = 0.0526). Within three months, rates of treatment intensification with systemic corticosteroids and/or antibiotics were 47 versus 60 percent (HR, 0.70; 95 percent CI, 0.51 to 0.97; P = 0.0272), respectively; rates of step-up in hospital care or readmission for respiratory reasons were 13 versus 28 percent (HR, 0.43; 95 percent CI, 0.25 to 0.75; P = 0.0024), and all-cause mortality was 2 versus 4 percent (HR, 0.62; 95 percent CI, 0.15 to 2.59; P = 0.5075). Six months after withdrawal, clinical benefits were lost.
"A positive message of the trial is that our strategy reduced hospital time, days in the intensive care unit, and recurrent exacerbations in the most severe COPD group," a coauthor said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including TEVA, which manufactures azithromycin and provided financial support for study logistics.