The use of moxifloxacin in smoking patients with exacerbation of chronic bronchitis
A recent international multicenter double-blind study on the effectiveness of moxifloxacin in exacerbating chronic bronchitis (ACB) in smokers involved 1,935 patients who had previously had episodes of ACB. Over 12 months of follow-up, BCS occurred in 733 patients who were randomized into two groups in a 1: 1 ratio. Patients in the main group received moxifloxacin 400 mg once daily for 5 days. Patients in the control group received standard treatment, including 500 mg amoxicillin 2 times daily or 500 mg clarithromycin 2 times daily or cefuroxime axetil 250 mg 2 times daily for 7 days.
The clinical evaluation of the patients was carried out before the exacerbation (to determine the initial state), during and after the treatment (to determine the time of return to the initial state). In addition, patients were observed for 9 months after treatment to assess long-term results, including the time until the next exacerbation. The primary endpoint of the study was the clinical efficacy of the treatment, which was evaluated 7-10 days after the end of treatment.
The results of the study showed a significantly higher clinical efficacy in the moxifloxacin group (70.9% compared to 62.8% in the control group). Microbiological efficacy was also significantly higher with moxifloxacin compared to the control group (92% and 81%, respectively).
The number of patients requiring an additional prescription for antibacterial drugs was lower in the moxifloxacin group (31% versus 40% with standard treatment, p = 0.03).
The remission period (the time until the next exacerbation of chronic bronchitis) was approximately two weeks longer with moxifloxacin.
Adverse events, considered to be possibly or probably related to the drugs studied, were observed in 7.1% of patients receiving moxifloxacin and 4.8% of patients in the control group. Of the 43 serious adverse events occurring during the study, 19 were observed in the moxifloxacin group and 24 in the control group. Two serious adverse events were considered to be possibly related to the drugs studied, both observed in the standard treatment group. The study drugs were stopped in 4 patients in each group (1.1%) due to the development of adverse events. During the study, 9 deaths were recorded, 3 in the moxifloxacin group and 6 in the control group, none of which was associated with the use of the drugs studied.