Levofloxacin versus cefuroxime axetil in the treatment of acute exacerbation of chronic bronchitis: results of a randomized, double-blind study

Abstract

A randomized, double-blind, double-dummy, three-arm parallel design, multicentre study was conducted among adult patients with acute exacerbation of chronic bronchitis (AECB) in order to compare the efficacy and safety of two different doses of levofloxacin with cefuroxime axetil. A total of 832 patients were randomized to receive oral levofloxacin (250 mg od or 500 mg od) or oral cefuroxime axetil (250 mg bd) for 7-10 days. The primary efficacy analysis was based on the clinical response in patients with bacteriologically confirmed AECB, determined 5-14 days after the end of therapy (per-protocol population). Of 839 patients enrolled (at 71 centres in 14 countries), seven were not treated, giving an intention-to-treat (ITT) population of 832. In total, 281 patients received levofloxacin 250 mg, 280 received levofloxacin 500 mg and 271 received cefuroxime axetil. The cure rates in the ITT population were: levofloxacin 250 mg, 70% (196/281); levofloxacin 500 mg, 70% (195/280); cefuroxime axetil, 61% (166/271); those in the per-protocol population were: 78% (121/156), 79% (108/137) and 66% (88/134), respectively. Both doses of levofloxacin were at least as effective as cefuroxime axetil and were active against the main pathogens of clinical relevance (Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis). All three treatment regimens were equally well tolerated. In conclusion, the results show that levofloxacin (250 mg and 500 mg) od is effective and well tolerated in the treatment of AECB in adult patients.

Guidelines for the management of adult lower respiratory tract infections

“…Levofloxacin and moxifloxacin are active against most of the strains of S. pneumoniae and H. influenzae and achieve high concentrations in bronchial secretions several times higher than the required MIC to treat these microorganisms [215][216][217][218][219]. In addition, they are active against Gram negative bacilli other than P. aeruginosa.…”

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

“…Thus, in severely ill patients (peak flow Յ300 L/min), 84 of 112 patients (75%) receiving PO levofloxacin (500 mg once daily) responded, compared with 74 of 117 patients (63%) receiving PO cefuroxime axetil. 40 In patients who were hospitalized or receiving concomitant steroids and theophylline, response rates were 76% (48/63) and 60% (34/57), respectively. Overall pathogen eradication in the per-protocol population was superior for levofloxacin-treated patients compared with cefuroxime axetil-treated patients (77% [98/127] vs 68% [84/124], respectively).…”

“…4 Even in severely ill patients, success rates approach 80% with agents such as levofloxacin. 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.…”

“…56,58 These findings contrast with those of PO moxifloxacin (25% in US and German trials) and gatifloxacin (29% in US trials), which were investigated in the late 1990s. 59,60 Later (Phase IV) studies of levofloxacin in generally sicker and older patients (eg, those with AECB) report rates of 19% to 21% in Europe, 40,45 South America, 40,45 and South Africa. 40 For common-class ADRs, rates for levofloxacin appear to be among the lowest of the class, irrespective of racial, geographic, or chronologic factors.…”

“…59,60 Later (Phase IV) studies of levofloxacin in generally sicker and older patients (eg, those with AECB) report rates of 19% to 21% in Europe, 40,45 South America, 40,45 and South Africa. 40 For common-class ADRs, rates for levofloxacin appear to be among the lowest of the class, irrespective of racial, geographic, or chronologic factors. 55,56 Thus, rates for GI reactions are 5.1% (class range, 3.4%-15%); CNS reactions, 0.2% to 1.1% (class range, 0.2%-5.4%); and dermatologic reactions, 0.2% (class range, 0.2% to exceptionally 5%).…”