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Cefpodoxime as ..

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Fluoroquinolones have been historically preferred over beta-lactam antibiotics for the treatment of cystitis due to superior cure rates.1-3 However, emerging fluoroquinolone resistance to Escherichia coli (E. coli), the predominant uropathogen implicated in urinary tract infections, has prompted further investigation of the use of alternative broad-spectrum antibiotics in the treatment of uncomplicated cystitis.4 The most up to date Infectious Disease Society of America (IDSA) guidelines for acute, uncomplicated cystitis, released in 2011, advocate for limited use of fluoroquinolones due to high resistance rates. Alternatively, the guidelines recommend first line treatment with trimethoprim-sulfamethoxazole, nitrofurantoin, fosfomycin, and pivmecillinam (a beta-lactam antibiotic available in Europe). The guidelines support the use of certain beta-lactam antibiotics as second line alternatives, but highlight the inferior cure rates and increased adverse events with beta-lactams when compared to first line agents.5 While many studies have demonstrated the inferiority of beta-lactam antibiotics in the treatment of urinary tract infections when compared to fluoroquinolones, limited data exists assessing the use of cefpodoxime, a broad spectrum, third generation cephalosporin, in the treatment of uncomplicated cystitis.2-4

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Hooton, et al. conducted a randomized, double blind, non-inferiority trial assessing the efficacy of short-course cefpodoxime in comparison to standard short-course ciprofloxacin for the treatment of acute, uncomplicated cystitis. Otherwise healthy females between the ages of 18 and 55 with a diagnosis of acute, uncomplicated cystitis, as evidenced by pyuria with a WBC count ≥ to 8 cells/mm3 and symptoms of frequency, urgency, or dysuria, were eligible for inclusion. Patients were excluded if they had anatomic urinary tract abnormalities, antimicrobial exposure within 2 weeks of the study, an allergy to the study drugs, or diabetes mellitus. Eligible patients were randomized in a 1:1 ratio to cefpodoxime 100mg twice daily for 3 days or ciprofloxacin 250mg twice daily for 3 days. The primary outcome assessed was overall clinical cure at 30 days, and secondary outcomes were clinical and microbiological cure at first follow-up, and vaginal E. coli colonization at each follow-up. A sample size of 226-280 patients was calculated for an 80-85% power at a 5% significance level using a 10% non-inferiority margin for cefpodoxime.4

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A total of 300 women were enrolled in the study. Baseline characteristics were similar between groups except for significantly fewer patients with less than 105 CFU/mL of uropathogen and significantly more patients with previous UTI or pyelonephritis at enrollment in the cefpodoxime group compared to the ciprofloxacin group. The majority of UTIs were caused by E. coli (75%). The primary outcome of overall clinical cure at 30 days was achieved in 93% (139/150) of patients on ciprofloxacin compared to 82% (123/150) of patients on cefpodoxime when patients lost to follow up were considered clinically cured (difference of 11%). When patients lost to follow-up were considered unresponsive to treatment, the primary outcome was achieved in 83% (124/150) of patients in the ciprofloxacin group, compared to 71% (106/150) of patients in the cefpodoxime group (difference of 12%). A per-protocol analysis ...

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