| Autor: |
Vermeersch, Kristina, Gabrovska, Maria, Aumann, Joseph, Demedts, Ingel K, Corhay, Jean-Louis, Marchand, Eric, Slabbynck, Hans, Haenebalcke, Christel, Haerens, Michiel, Hanon, Shane, Jordens, Paul, Peché, 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, BACE trial investigators |
| Přispěvatelé: |
UCL - (MGD) Service de pneumologie, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
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| Zdroj: |
American journal of respiratory and critical care medicine, Vol. 200, no. 7, p. 857-868 (2019) |
| Popis: |
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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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