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


METHODS
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=3 episodes in the previous year and 88.6% 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.


CONCLUSIONS
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.
Benhamou
D
D
Service de pneumologie, hôpital de Bois-Guillaume, 76031 Rouen cedex, France. daniel.benhamou@chu-rouen.fr
Zuck
P
P
Piperno
D
D
Tremolieres
F
F
D000208:Acute Disease; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D005260:Female; D005602:France; D006801:Humans; D048628:Ketolides / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011331:Private Practice; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications* / Q000188:drug therapy*; D012307:Risk Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D048628:Ketolides; C106791:telithromycin