Efficacy and safety of gemifloxacin in the treatment of acute exacerbation of chronic obstructive pulmonary disease: open prospective multicentre study

Abstract

Objective: to study the clinical and antibacterial efficacy and safety of gemifloxacin in the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE COPD) hospitalized into pulmonology departments. Study design: open non-comparative prospective study. Settings: 25 different pulmonology centres in Russia. A total of 222 patients with AE COPD (156 males and 66 females, mean age 56,4 ± 11,9 years) were included in the study. The majority of patients (70.3 %) were classified as I type Anthonisen of AE COPD. All patients received oral gemifloxacin (Factive ® , Veropharm, Russia) 320 mg once daily for 7 days. Clinical and bacteriological outcomes and treatment safety were assessed at the end of therapy (7–8 days of study) and at follow up (14–16 days of study). At the end of therapy (7–8 days) statistically significant improvements were noted in all symptoms of AE COPD (improvement of cough, dyspnea, sputum volume and purulence). No clinical improvement was seen in 5.6 % of patients, so the clinical success rate of gemifloxacin therapy was 94.4 %. Sputum cultures were performed in 73.0 % of patients and in 60.4 % of them respiratory pathogens were isolated. The leading pathogens were Streptococus pneumoniae (37.7 %) and Haemophilus influenzae (27.8 %). Eradication and presumed eradication of all pathogens were 69.4 % and 26.9 %, respectively. The bacteriological success rate of gemifloxacin therapy was 96.3 %. A total of 15 patients reported adverse events (AEs), most frequent AEs was diarrhea (4.7 %). All AEs were no severe and transitory, and did not require the withdrawal of antibiotic therapy. Oral gemifloxacin had high clinical and bacteriological efficacy in hospitalized patients with AE COPD. The treatment with gemifloxacin was generally well tolerated and was convenient to patients.