Efficacy and Tolerability of Moxifloxacin in 2338 Patients With Acute Exacerbation of Chronic Bronchitis
Abstract
Objective: A post-marketing surveillance (PMS) study was conducted to evaluate the efficacy and tolerability of moxifloxacin 400mg once daily in patients with acute exacerbation of chronic bronchitis (AECB) treated by pulmonologists and pulmonary specialists in community-based practice settings.
Patient and methods: 2338 patients with AECB (54% male; 46% female) were included in the analysis. PMS studies are prospective, open, uncontrolled and observational in design. All therapeutic decisions were made by the attending physician, based on their clinical practice and experience. This approach was adopted in order to provide valuable information on the safety and efficacy of moxifloxacin therapy in routine clinical practice.
, http://www.100md.com
Results: The main symptoms of AECB (cough, expectoration, dyspnoea, chest pain and fever) were either resolved or improved in 80-97% of patients. Most patients (65%) improved within 3 days of starting moxifloxacin therapy and
91.6% by day 5. Mean time to improvement was 3.2 ± 1.6 days. Overall, 96.1% of patients were judged by their physician to be either cured or improved following moxifloxacin therapy. Approximately 57% of patients had previously been treated with an antibiotic for their last episode of AECB. The antibiotics used were mostly macrolides (18.2% of patients), beta-lactams (16.9%), tetracycline/ doxycycline (9.9%) and quinolones (9.5%). The tolerability of moxifloxacin therapy was rated as 'very good' or 'good' in 95.4% of patients. Adverse events were reported in only 1.5% of patients.
, 百拇医药
Conclusion: In conclusion, moxifloxacin 400mg once daily was effective and well tolerated in this group of patients with AECB, combined with a rapid onset of action and a similarly high clinical success rate to that observed in controlled comparative clinical trials.
Introduction
In 1996 an estimated 14 million men and women in the US had chronic bronchitis, similar to the number who had asthma.[1] From these surveys chronic bronchitis appeared to have increased markedly compared with two decades earlier. High rates of respiratory disease are also reported in other industrialised countries. For example, approximately 10% of the adult population in Germany are estimated to have chronic bronchitis.[2] In Spain, an epidemiological study involving over 4000 men and women estimated the prevalence of chronic obstructive pulmonary disease (COPD) at 9.1%, with wide variations between the geographic regions covered (from 4.9 to 18%).[3]
, 百拇医药
Acute exacerbations of chronic bronchitis (AECB) are recurrent episodes of worsening symptoms, such as increased breathlessness (dyspnoea), an increase in sputum volume, and occurrence of purulent sputum.[4] Dyspnoea is perhaps the most distressing and disabling symptom of chronic bronchitis. Importantly, in patients with advanced respiratory illness, AECB tend to increase in frequency and severity, and may have a significant impact on morbidity and quality of life, as well as on mortality.[2,5]
, 百拇医药
The aetiology of AECB is multifactorial, with bacterial infection suspected in 50% of cases.[6] Empirical antibiotic therapy for AECB remains controversial.[7] Nevertheless, most patients, particularly those with more severe episodes, appear to benefit from antibiotic therapy.[8] The most common bacterial species isolated are nontypable Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae. In addition, atypical bacteria, mainly Chlamydia pneumoniae, are thought to be involved in up to 10% of cases. The challenge in treating patients with AECB is to find an appropriate antimicrobial treatment regimen that is both effective and provides reliable coverage against the range of pathogens likely to be encountered.
, 百拇医药
Moxifloxacin is a novel 8-methoxy-fluoroquinolone with a broad spectrum of activity against commonly encountered respiratory tract pathogens.[9-16] Rapid bactericidal activity against both Gram-positive and Gram-negative organisms and a high degree of penetration into body tissues and fluids have been demonstrated with moxifloxacin.[17,18] Moxifloxacin possesses activity against penicillin-and macrolide-resistant strains of S. pneumoniae, and beta-lactamase-negative and -positive Haemophilus strains, as well as against atypical pathogens.[19]
, 百拇医药
Short-course (5-day) therapy with moxifloxacin 400mg once daily has been shown to be effective and well tolerated in the treatment of patients with AECB.[20] In controlled clinical trials versus commonly used antimicrobial regimens, moxifloxacin 400mg once daily for 5 days produced bacteriological and/or clinical success rates of around 90% or higher.[21-27] Moreover, moxifloxacin is reported to provide rapid relief from the signs and symptoms of AECB, with around two-thirds of patients clinically improved by day 3.[28-31]
, 百拇医药
The aim of this post-marketing surveillance (PMS) study, involving over 2300 patients with AECB treated in general practice settings in Germany, was to investigate the efficacy and tolerability of treatment with moxifloxacin 400mg once daily. In particular, the study examined the time-course of onset of improvement and recovery, as well as patient acceptance and satisfaction with treatment in general and in comparison with previous antibiotic AECB therapies., 百拇医药(J. Barth, H. Landen)
Objective: A post-marketing surveillance (PMS) study was conducted to evaluate the efficacy and tolerability of moxifloxacin 400mg once daily in patients with acute exacerbation of chronic bronchitis (AECB) treated by pulmonologists and pulmonary specialists in community-based practice settings.
Patient and methods: 2338 patients with AECB (54% male; 46% female) were included in the analysis. PMS studies are prospective, open, uncontrolled and observational in design. All therapeutic decisions were made by the attending physician, based on their clinical practice and experience. This approach was adopted in order to provide valuable information on the safety and efficacy of moxifloxacin therapy in routine clinical practice.
, http://www.100md.com
Results: The main symptoms of AECB (cough, expectoration, dyspnoea, chest pain and fever) were either resolved or improved in 80-97% of patients. Most patients (65%) improved within 3 days of starting moxifloxacin therapy and
91.6% by day 5. Mean time to improvement was 3.2 ± 1.6 days. Overall, 96.1% of patients were judged by their physician to be either cured or improved following moxifloxacin therapy. Approximately 57% of patients had previously been treated with an antibiotic for their last episode of AECB. The antibiotics used were mostly macrolides (18.2% of patients), beta-lactams (16.9%), tetracycline/ doxycycline (9.9%) and quinolones (9.5%). The tolerability of moxifloxacin therapy was rated as 'very good' or 'good' in 95.4% of patients. Adverse events were reported in only 1.5% of patients.
, 百拇医药
Conclusion: In conclusion, moxifloxacin 400mg once daily was effective and well tolerated in this group of patients with AECB, combined with a rapid onset of action and a similarly high clinical success rate to that observed in controlled comparative clinical trials.
Introduction
In 1996 an estimated 14 million men and women in the US had chronic bronchitis, similar to the number who had asthma.[1] From these surveys chronic bronchitis appeared to have increased markedly compared with two decades earlier. High rates of respiratory disease are also reported in other industrialised countries. For example, approximately 10% of the adult population in Germany are estimated to have chronic bronchitis.[2] In Spain, an epidemiological study involving over 4000 men and women estimated the prevalence of chronic obstructive pulmonary disease (COPD) at 9.1%, with wide variations between the geographic regions covered (from 4.9 to 18%).[3]
, 百拇医药
Acute exacerbations of chronic bronchitis (AECB) are recurrent episodes of worsening symptoms, such as increased breathlessness (dyspnoea), an increase in sputum volume, and occurrence of purulent sputum.[4] Dyspnoea is perhaps the most distressing and disabling symptom of chronic bronchitis. Importantly, in patients with advanced respiratory illness, AECB tend to increase in frequency and severity, and may have a significant impact on morbidity and quality of life, as well as on mortality.[2,5]
, 百拇医药
The aetiology of AECB is multifactorial, with bacterial infection suspected in 50% of cases.[6] Empirical antibiotic therapy for AECB remains controversial.[7] Nevertheless, most patients, particularly those with more severe episodes, appear to benefit from antibiotic therapy.[8] The most common bacterial species isolated are nontypable Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae. In addition, atypical bacteria, mainly Chlamydia pneumoniae, are thought to be involved in up to 10% of cases. The challenge in treating patients with AECB is to find an appropriate antimicrobial treatment regimen that is both effective and provides reliable coverage against the range of pathogens likely to be encountered.
, 百拇医药
Moxifloxacin is a novel 8-methoxy-fluoroquinolone with a broad spectrum of activity against commonly encountered respiratory tract pathogens.[9-16] Rapid bactericidal activity against both Gram-positive and Gram-negative organisms and a high degree of penetration into body tissues and fluids have been demonstrated with moxifloxacin.[17,18] Moxifloxacin possesses activity against penicillin-and macrolide-resistant strains of S. pneumoniae, and beta-lactamase-negative and -positive Haemophilus strains, as well as against atypical pathogens.[19]
, 百拇医药
Short-course (5-day) therapy with moxifloxacin 400mg once daily has been shown to be effective and well tolerated in the treatment of patients with AECB.[20] In controlled clinical trials versus commonly used antimicrobial regimens, moxifloxacin 400mg once daily for 5 days produced bacteriological and/or clinical success rates of around 90% or higher.[21-27] Moreover, moxifloxacin is reported to provide rapid relief from the signs and symptoms of AECB, with around two-thirds of patients clinically improved by day 3.[28-31]
, 百拇医药
The aim of this post-marketing surveillance (PMS) study, involving over 2300 patients with AECB treated in general practice settings in Germany, was to investigate the efficacy and tolerability of treatment with moxifloxacin 400mg once daily. In particular, the study examined the time-course of onset of improvement and recovery, as well as patient acceptance and satisfaction with treatment in general and in comparison with previous antibiotic AECB therapies., 百拇医药(J. Barth, H. Landen)