title: Efficacy and safety of short course (5-day) moxifloxacin vs 7-day ceftriaxone in the treatment of acute exacerbations of chronic bronchitis (AECB).
abstract: The aim of this multicenter, open, randomized study was to compare the efficacy and tolerability of a 5-day treatment course with oral moxifloxacin (MXF) vs a 7-day course with i.m. ceftriaxone (CRO) in 476 patients with acute exacerbations of chronic bronchitis (AECB), and to conduct a cost minimization analysis of the two treatments from the perspectives of both the Italian National Health Service (INHS) and society. The study was conducted in Italy. Clinical success rates at test-of-cure in the 423 patients of the PP (Per Protocol) population (primary efficacy parameter) were 90.6% and 89.0% for MXF and CRO, respectively. Statistical non-inferiority of MXF vs CRO was confirmed. Similar results were found between study drugs on the secondary efficacy parameters, including success at end-of-treatment (95.3% for MXF vs 92.9% for CRO), success at test-of-cure in bacteriologically-positive patients (94.1% vs 90.7%) and eradication/presumed eradication rates (91.7% vs 93.3%). ITT (Intention-to-Treat) analysis confirmed these data. There was a low incidence of adverse events (10.8% vs 9.1%). During a 6-month follow-up period, relapse rates were lower for MXF vs CRO (23.3% vs 28.3%; p > .05). Compared with CRO, MXF was associated with cost savings per patient ranging from Euro226.57 (INHS perspective) to Euro448.23 (societal perspective), with lower hospitalization rate the major variable contributing to reduced costs. MXF appears to be an ideal candidate for AECB treatment.
authors.affiliation: Pneumology Department, University of Pavia, Italy. grassicarlo@tiscali.it
authors.forename: C
authors.initials: C
authors.lastname: Grassi
authors.forename: L
authors.initials: L
authors.lastname: Casali
authors.forename: E
authors.initials: E
authors.lastname: Curti
authors.forename: M
authors.initials: M
authors.lastname: Tellarini
authors.forename: C
authors.initials: C
authors.lastname: Lazzaro
authors.forename: G
authors.initials: G
authors.lastname: Schito
mesh_terms: D000208:Acute Disease; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D001372:Aza Compounds; D029481:Bronchitis, Chronic / Q000188:drug therapy* / Q000191:economics; D002443:Ceftriaxone / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D003365:Costs and Cost Analysis; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009313:National Health Programs / Q000191:economics; D011804:Quinolines; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D002443:Ceftriaxone; D000077266:Moxifloxacin