Comparative efficacy and safety of five-day moxifloxacin and seven-day ceftriaxone treatment of AECB: results of the SMART study
C. Grassi, G. Schito, L. Casali, E. Curti, M. Tellarini (Pavia, Genova, Perugia, Milano, Italy)
Source: Annual Congress 2002 - Acute exacerbations of COPD: aetiology and therapy
Session: Acute exacerbations of COPD: aetiology and therapy
Session type: Thematic Poster Session
Number: 3376
Disease area: Airway diseases, Respiratory infections
Abstract Objective : This study was designed to evaluate efficacy and safety of two different treatments, moxifloxacin (MXF) and ceftriaxone (CRO), in patients with acute exacerbations of chronic bronchitis (AECB). Healthcare (and non) related costs were also evaluated. Methods : 476 patients with AECB (Anthonisen II and II) were randomised to moxifloxacin (400 mg OD orally for 5 days) or ceftriaxone (1g OD intramuscularly for 7 days) in a multicenter clinical trial in Italy. Test-of-Cure (TOC) was 10 days after end of treatment and included clinical/microbiological response. Cost minimisation analyses (CMA) from the Italian National Healthcare (INHC) and societal perspectives were undertaken. Results : In 423 patients (213 MXF, 210 CRO) per protocol (PP) clinical success rates at TOC (90,6% MXF and 89,0% CRO) were statistically equivalent [95% CI for the +1,6% difference: -4,2 % - + 7,4%]. AECB relapse rates during 6 months follow-up were 23,3% (MXF) and 28,3% (CRO). Bacterial eradication in 66 patients was 92,1% with MXF and 94,6% with CRO. Adverse events (AE) were similar in both groups. MXF allowed a cost-saving, mainly due to hospitalisation and drug costs, ranging from € 314,80 (INHS perspective) to 395,58 (societal perspective) per patient. Conclusions : In AECB patients a 5-day oral treament with moxifloxacin was as effective and safe as 7-day intramuscular treatment with ceftriaxone. Economic analysis showed a cost-saving of €314,80-395,58 per patient treated with MXF. In addition to shorter treatment duration and lower rate of exacerbations, other potential benefits of MXF included better compliance and reduced health care costs.
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C. Grassi, G. Schito, L. Casali, E. Curti, M. Tellarini (Pavia, Genova, Perugia, Milano, Italy). Comparative efficacy and safety of five-day moxifloxacin and seven-day ceftriaxone treatment of AECB: results of the SMART study. Eur Respir J 2002; 20: Suppl. 38, 3376
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