Efficacy and safety of cefditoren pivoxil for exacerbations of chronic obstructive pulmonary disease: A prospective multicenter interventional study

Abstract Oral antibiotic therapy for patients with acute exacerbationsof chronic obstructive pulmonary disease(COPD) usually involves an aminopenicillinwith clavulanic acid, a macrolide, or a quinolone. To date, however, the clinical efficacy and safety of the oral cephalosporin cefditorenpivoxil has not been evaluated in Japanese patients with acute exacerbationsof COPD. We conducted a prospective, multicenter, single arm, interventional study from January 2013 to March 2017 to determine the efficacy and safety of oral administration of 200 mg cefditorenpivoxil three times daily for 7 days in a cohort of 29 eligible patients from 15 hospitals. The mean age (SD) of participants was 73.1 (8.1) years and 28 had a smoking history (the mean [SD] of smoking index, 1426.7 [931.7]). The primary efficacy endpoint was clinical response (cure rate) at test of cure, which was set at 5–10 days after treatment ceased. Of the 23 patients finally analyzed, cure was achieved in 15 (65.2%), while 8 (34.8%) remained uncured. Previous experience of acute exacerbationssignificantly affected the cure rate: none of the three patients who had at least two prior exacerbationswere cured, while 15 of the 20 patients with one or fewer prior exacerbationswere cured (p = 0.032). The microbiological eradication rate was 88.9% at test of cure. During treatment, mild pneumonia was reported as an adverse event in one patient (3.4%) but resolved within 10 days of onset. We conclude that cefditorenpivoxil represents a viable alternative for antibiotic therapy in patients with few prior exacerbations.