Antibiotic treatment and factors influencing short and long-term outcomes of acute exacerbations of chronic bronchitis

Robert Wilson ^1*, Paul Jones ², Tom Schaberg ³, Pierre Arvis ⁴, Isabelle Duprat-Lomon ⁵ and Pierre Sagnier ⁶

¹ Royal Brompton Hospital, London, United Kingdom
² St George Hospital Medical School, London, United Kingdom
³ Zentrum für Pneumologie, Diakoniekrankenhaus, Rotenburg, Germany
⁴ Medical Affairs, Bayer Pharma, Puteaux, France
⁵ Global HEOR, Bayer Pharma, Puteaux, France
⁶ Global HEOR, Bayer Plc, Uxbridge, United Kingdom

^* To whom correspondence should be addressed. E-mail: r.wilson{at}rbh.nthames.nhs.uk.

Accepted 30 December 2005

Abstract

Background: The MOSAIC study compared moxifloxacin to 3 standard antibiotic regimens in Anthonisen type 1 acute exacerbations of chronic bronchitis (AECB). Further exploratory analyses were performed to identify prognostic factors of short and long term clinical outcomes, and their value for clinical research.

Methods: Outpatients 45 years were screened between AECB episodes, randomized to treatment upon presenting with an AECB, assessed 7-10 days after study treatment, and followed monthly until a new AECB or up to 9 months. Logistic regression assessed the predictive factors for clinical cure (return to pre-AECB status) and clinical success (cure or improvement), and a stepwise Cox regression model time to a composite event (failure of study treatment, new AECB, or further antibiotic treatment for AECB).

Results: In multivariate analyses, clinical cure was positively influenced by treatment with moxifloxacin (Odds Ratio=1.499), while cardiopulmonary disease (OR=0.58), FEV1 <50% predicted (OR=0.48) and >4 AECB in previous year (OR=0.68) predicted poorer outcome. For clinical success, treatment with moxifloxacin had a positive influence (OR=1.57), while cardiopulmonary disease (OR: 0.41) and use of acute bronchodilatators (OR; 0.50) predicted poorer outcome. The occurrence of the composite event was influenced by antibiotic treatment (Hazard Ratio=0.82), age >65 years (HR=1.22), FEV1<50% predicted (HR=1.27), >4 AECB in previous year (HR=1.63) and acute bronchodilator use (HR=1.48). For the composite event the beneficial effect of moxifloxacin was primarily seen in patients aged >65 years.

Conclusion: Despite selection of a homogeneous population of chronic bronchitis patients between group differences relating to antibiotic treatment could still be confounded by factors related to medical history, severity of disease and use of concomitant medicators. Design of future clinical trials should take these factors into account.

Keywords: antibiotic, exacerbation of chronic bronchitis, moxifloxacin, prognostic factor, treatment outcome

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