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[Efficacy and safety of telithromycin in the treatment of acute exacerbation of chronic obstructive pulmonary disease].

Abstract：

UNLABELLED:The aim of this study was to evaluate the clinical efficacy of telithromycin administered for 5 days at a dosage of 800 mg/day, in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) presenting with at least 2 of Anthonisen's criteria including the increase of purulence. METHODOLOGY:During this multicenter (211 private lung specialists), prospective, non-comparative, open-labeled French study, 365 patients were included between April 2002 and March 2003. Clinical efficacy was assessed on D12-D19 by the rate of clinical success as defined by recovery or clinical improvement (main endpoint) according to the number of exacerbation episodes during the previous year. RESULTS:On D12-D19 clinical success rate in the per protocol global population was 88.0% and respectively 87.9% in patients with or=4 episodes in the previous year. These success rates were similar to those in the intent-to-treat population. Safety, assessed on 359 patients, was satisfactory, with mainly digestive disorders related to the treatment in 3.9% of the patients. No treatment-related serious adverse events were observed. CONCLUSION:This study, conducted among private practitioners in France according to COPD classification as defined by official recommendations, validates the results obtained in previous studies. Our results confirm the place attributed to telithromycin in the treatment of patients presenting with AECOPD without chronic respiratory failure, according to ongoing official recommendations.

journal_name

Med Mal Infect

journal_title

Medecine et maladies infectieuses

authors

Benhamou D,Zuck P,Piperno D,Tremolieres F,Groupe Investigateur.

doi

10.1016/j.medmal.2005.08.008

keywords:

subject

Has Abstract

pub_date

2005-09-01 00:00:00

pages

455-62

issue

9

eissn

0399-077X

issn

1769-6690

pii

S0399-077X(05)00220-9

journal_volume

35

pub_type

临床试验,杂志文章,多中心研究

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