Five day moxifloxacin therapy compared with 7 day clarithromycin therapy for the treatment of acute exacerbations of chronic bronchitis

Abstract

In this multinational, randomized, double-blind study, the efficacy and safety of a 5 day course of moxifloxacin 400 mg orally od was compared with that of a 7 day course of clarithromycin 500 mg orally bd. in 750 patients with acute exacerbations of chronic bronchitis, characterized by at least two of the symptoms: sputum purulence, increased sputum volume or increased dyspnoea. Seven days after the end of therapy, clinical cure was achieved for 89% (287 of 322) of efficacy-evaluable patients in the moxifloxacin group and 88% (289 of 327) of patients in the clarithromycin group (95% CI, -3.9%, 5.8%). At follow-up (21-28 days post-treatment), the continued clinical cure rates were 89% (256 of 287) for moxifloxacin and 89% (257 of 289) for clarithromycin. A total of 342 pathogenic bacteria were isolated from the sputum of 287 patients. The most common pathogens were Haemophilus influenzae (37%), Streptococcus pneumoniae (31%) and Moraxella catarrhalis (18%). Seven days post-treatment, a successful bacteriological response was obtained for 77% (89 of 115) of patients in the moxifloxacin group and 62% (71 of 114) of patients in the clarithromycin group, indicating superiority of moxifloxacin (95% CI, 3.6%, 26.9%). Both treatments were well tolerated with few adverse events. This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 5 day course of moxifloxacin 400 mg od was clinically equivalent and bacteriologically superior to a 7 day course of clarithromycin 500 mg bd.

Patient stratification in the management of acute bacterial exacerbation of chronic bronchitis: the role of levofloxacin 750 mg

“…As ABECB is known to diminish QoL [2][3][4][5] and increase the likelihood of hospitalisation and repeated antibacterial courses [7,25,26], results from a daily diary and a respiratory healthcare utilisation questionnaire were utilised to demonstrate the rapid resolution of symptoms in both uncomplicated and complicated levofloxacin patients. Others have also suggested improved symptom resolution, health status and healthcare utilisation with quinolones in selected ABECB patients [27][28][29].…”

“…As a concentration-dependent agent [28][29][30][31][32][33], therapeutic outcome with levofloxacin is most closely linked to area under the concentration-time curve/minimum inhibitory concentration (MIC) or maximum concentration/MIC ratios. This pharmacodynamic principle, paired with levofloxacin's favourable safety index (which allows flexible dosing), supports the approach of using higher doses, such as the 750-mg dose, to achieve rapid microbiological eradication, rapid resolution of the clinical signs and symptoms of infection, and to allow for a shorter duration of therapy.…”

Sputum colour and bacteria in chronic bronchitis exacerbations: a pooled analysis

“…Baseline data were pooled from six clinical trials with similar methodologies comparing moxifloxacin with other antimicrobials in patients with an AECB (table 1) to determine the relationship between infection and sputum colour [6][7][8][9][10]. All clinical trials were prospective, randomised, controlled, multicentre studies conducted in Europe and North America.…”

Efficacy and safety of levofloxacin in the context of other contemporary fluoroquinolones: a review

“…40 An initial clinical study 41 assessing the use of levofloxacin in mild to moderate AECB therapy (500 mg once daily for 5-7 days) showed clinical response in 92% of patients. In somewhat more severe AECB, studies assessing moxifloxacin 42,43 (400 mg once daily for 5 days) or gatifloxacin (400 mg once daily for 5 days) 44 as AECB treatment reported response rates of 89% and 91%, respectively. Such excellent results are to be expected with agents that penetrate well into the site of infection and are highly active against the causative pathogens of AECB.…”