Moxifloxacin vs amoxicillin/clavulanic acid in outpatient AECOPD: maestral results.
Author(s): Wilson R, Anzueto A, Miravitlles M, Arvis P, Alder J, Haverstock D, Trajanovic M, Sethi S
Affiliation(s): Royal Brompton Hospital, London, UK.
Publication date & source: 2011-12-01, Eur Respir J., [Epub ahead of print]
Bacterial infections causing acute COPD exacerbations (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice.MAESTRAL was a multiregional, randomised, double-blind non-inferiority outpatient study. Patients were >/=60 years, with an Anthonisen type 1 exacerbation, FEV1<60% predicted and >/=2 exacerbations in the last year. Following stratification by steroid use patients received moxifloxacin 400 mg PO q.d. (5-days) or amoxicillin/clavulanic acid 875/125 mg PO b.d. (7-days). The primary endpoint was clinical failure 8-weeks post-therapy in the per protocol (PP) population.Moxifloxacin was non-inferior to amoxicillin/clavulanic acid at the primary endpoint (111/538, 20.6% vs 114/518, 22.0%, 95% CI -5.89, 3.83). In patients with confirmed bacterial AECOPDs, moxifloxacin led to significantly lower clinical failure rates than amoxicillin/clavulanic acid (ITT with pathogens, 62/327, 19.0% vs 85/335, 25.4%, P=0.016). Confirmed bacterial eradication at EOT was associated with higher clinical cure rates at 8-weeks post-therapy overall (P=0.0014) and for moxifloxacin (P=0.003). Patients treated with oral corticosteroids had more severe disease and higher failure rates.The MAESTRAL study showed that moxifloxacin was as effective as amoxicillin/clavulanic acid in the treatment of outpatients with AECOPD. Both therapies were well tolerated.