Prulifloxacin vs Levofloxacin for Exacerbation of COPD after Failure of Other Antibiotics

Abstract

The chronic course and evolution of chronic obstructive pulmonary disease (COPD) is often characterized by periods of exacerbation of symptoms, which have a negative impact on the quality of life of patients, as well as on the evolution of COPD, and represent a significant cause of medical intervention and hospitalization. Very few data are available on the efficacy of rescue antibiotics in patients with acute exacerbation of COPD (AECOPD) unresponsive to previous treatment. The aim of this study was to evaluate the efficacy of two fluoroquinolones in AECOPD previously treated without success. The FADOI-FLOR study is a randomized, single-blind, non-inferiority comparison between levofloxacin and prulifloxacin. Primary end-point was "therapeutic success" at Day 10 of treatment, defined as disappearance of signs/symptoms or decrease of at least three points of a global score of symptomatology (maximum score = 15). 258 patients were enrolled (128 levofloxacin and 130 prulifloxacin), in 25 centers. A very high proportion of patients in the two groups had therapeutic success at Day-10 (levofloxacin 93.0% vs prulifloxacin 96.7%, population intention-to-treat; 94.6% vs 99.1%, population per-protocol). Earlier therapeutic success (within 7 days) was achieved in 32.0% and 36.2% of patients receiving levofloxacin or prulifloxacin, respectively. At 3-month follow-up, re-exacerbations occurred in 17.8% of patients treated with levofloxacin and 14.2% of those receiving prulifloxacin (p = 0.44). In conclusion, fluoroquinolones are very effective in the treatment of AECOPD resistant to other antibiotics.

Prulifloxacin Effectiveness in Moderate-to-Severe Acute Exacerbations of Chronic Bronchitis: Α Noninterventional, Multicentre, Prospective Study in Real-Life Clinical Practice—The “AIOLOS” Study

“…In addition, prulifloxacin demonstrated a manageable safety profile, with the incidence rate of related AEs being 1.3%, similar to that reported in other studies with fluoroquinolones of a similar design and follow-up duration [16,22,23]. e observed events are among those expected based on accumulated safety data for prulifloxacin and the class of fluoroquinolones [17,26]. Physicians rated the tolerability of prulifloxacin as "very good" or "good" in 94.4% of the patients.…”

“…In one RCT, the response rate (clinical cure/ improvement) of treatment with prulifloxacin for 10 days was approximately 85% [13]. In addition, a 92.5% treatment success rate was reported in a trial comparing prulifloxacin to amoxicillin/clavulanate [12], while a response rate of 96.7% on Day 10 of prulifloxacin treatment was shown in a sample of patients with COPD suffering an acute exacerbation unresponsive to previous antibiotics [17]. Similarly, the current study demonstrated a 91.7% symptom improvement rate at the 7-10-day postbaseline follow-up visit.…”

Antibiotics for treatment of acute exacerbation of chronic obstructive pulmonary disease: a network meta-analysis

“…Ultimately, 19 articles, published between 1996 and 2016, that assessed 5906 patients were collected for our systematic review (Fig. 1 , Table 1 ) [ 19 – 37 ]. One of the included trials contained four intervention arms [ 36 ].…”

<p>How Do Innate Immune Cells Contribute to Airway Remodeling in COPD Progression?</p>

“…87 Fluoroquinolones have been found to inhibit NF-κB activation, and thereby reduce the levels of IL-1, IL-6, and TNF-α in an animal model of COPD. 87 Giusti et al 88 conducted a randomized controlled trial to determine whether fluoroquinolones could exert additional benefits in patients with acute exacerbations of COPD, apart from its anti-infective effects. 89 Other antibiotics, such as ceftaroline, which could counteract the effects of cigarette smoking, induces TLR expression in bronchial epithelial cells and monocytes, and may increase the effectiveness of the innate immune response to pathogen activity in the lungs of patients with COPD.…”