Reference : Azithromycin during Acute Chronic Obstructive Pulmonary Disease Exacerbations Requiri...
Scientific journals : Article
Human health sciences : Cardiovascular & respiratory systems
Azithromycin during Acute Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization (BACE). A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial.
Vermeersch, Kristina [> >]
Gabrovska, Maria [> >]
Aumann, Joseph [> >]
Demedts, Ingel K. [> >]
Corhay, Jean-Louis mailto [Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques >]
Marchand, Eric [> >]
Slabbynck, Hans [> >]
Haenebalcke, Christel [> >]
Haerens, Michiel [> >]
Hanon, Shane [> >]
Jordens, Paul [> >]
Peche, Rudi [> >]
Fremault, Antoine [> >]
Lauwerier, Tine [> >]
Delporte, Anja [> >]
Vandenberk, Bert [> >]
Willems, Rik [> >]
Everaerts, Stephanie [> >]
Belmans, Ann [> >]
Bogaerts, Kris [> >]
Verleden, Geert M. [> >]
Troosters, Thierry [> >]
Ninane, Vincent [> >]
Brusselle, Guy G. [> >]
Janssens, Wim [> >]
American journal of respiratory and critical care medicine
Yes (verified by ORBi)
United States
[en] composite ; macrolide ; readmission ; time to event ; treatment failure
[en] Rationale: Azithromycin prevents acute exacerbations of chronic obstructive pulmonary disease (AECOPDs); however, its value in the treatment of an AECOPD requiring hospitalization remains to be defined.Objectives: We investigated whether a 3-month intervention with low-dose azithromycin could decrease treatment failure (TF) when initiated at hospital admission and added to standard care.Methods: In an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial, patients who had been hospitalized for an AECOPD and had a smoking history of >/=10 pack-years and one or more exacerbations in the previous year were randomized (1:1) within 48 hours of hospital admission to azithromycin or placebo. The study drug (500 mg/d for 3 d) was administered on top of a standardized acute treatment of systemic corticosteroids and antibiotics, and subsequently continued for 3 months (250 mg/2 d). The patients were followed for 6 months thereafter. Time-to-first-event analyses evaluated the TF rate within 3 months as a novel primary endpoint in the intention-to-treat population, with TF defined as the composite of treatment intensification with systemic corticosteroids and/or antibiotics, a step-up in hospital care or readmission for respiratory reasons, or all-cause mortality.Measurements and Main Results: A total of 301 patients were randomized to azithromycin (n = 147) or placebo (n = 154). The TF rate within 3 months was 49% in the azithromycin group and 60% in the placebo group (hazard ratio, 0.73; 95% confidence interval, 0.53-1.01; P = 0.0526). Treatment intensification, step-up in hospital care, and mortality rates within 3 months were 47% versus 60% (P = 0.0272), 13% versus 28% (P = 0.0024), and 2% versus 4% (P = 0.5075) in the azithromycin and placebo groups, respectively. Clinical benefits were lost 6 months after withdrawal.Conclusions: Three months of azithromycin for an infectious AECOPD requiring hospitalization may significantly reduce TF during the highest-risk period. Prolonged treatment seems to be necessary to maintain clinical benefits.

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