Cefpodoxime failed to meet treatment potential for acute cystitis in women
Hooton TM. JAMA. 2012;307:583-589.
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Compared with standard therapy ciprofloxacin for acute uncomplicated cystitis in women, cefpodoxime did not meet noninferiority criteria in a randomized trial. Therefore, researchers from the University of Miami and the University of Washington do not support cefpodoxime as first-line therapy in this patient population.
Thomas M. Hooton, MD, of the University of Miami, and colleagues set out to assess whether cefpodoxime would have clinically acceptable efficacy and tolerance compared with standard therapy ciprofloxacin. The researchers hypothesized that cefpodoxime would be noninferior to ciprofloxacin by a 10% margin.
“Although extended-spectrum cephalosporins such as cefpodoxime have good activity against [urinary tract infection] pathogens, the expected efficacy with beta-lactam drugs has in general been low compared with trimethoprim-sulfamethoxazole or fluoroquinolones,” the researchers wrote in the study. “We have speculated that the lower clinical response with beta-lactams compared with other first-line antimicrobials may be due to their poorer activity in eradicating the uropathogen from the vaginal flora.”
From 2005 to 2009, researchers evaluated data on 300 women aged 18 to 55 years. Half of the women were treated with 100 mg oral cefpodoxime twice daily for 3 days, and the second half were given 250 mg oral ciprofloxacin twice daily for 3 days. Outcomes were assessed between 5 and 9 days and between 28 and 30 days after therapy completion.
At 30-day follow-up, the overall clinical cure rate was 93% for ciprofloxacin compared with 82% for cefpodoxime. Moreover, cefpodoxime did not meet the noninferiority margin of 10% for achieving clinical cure.
Compared with a microbial cure rate of 96% with ciprofloxacin, the cure rate was 81% in women assigned cefpodoxime (difference of 15%; 95% CI, 8-23). Vaginal Escherichia coli colonization was observed at first follow-up in 40% of women assigned cefpodoxime vs. only 16% of women assigned ciprofloxacin.
“As recommended in recently published guidelines, nitrofurantoin, trimethoprim/sulfamethoxazole (except in areas where the resistance prevalence is known to be high), fosfomycin and pivmecillinam (not available in the United States) should be considered before fluoroquinolones and beta-lactams such as cefpodoxime for patients with uncomplicated cystitis,” the researchers wrote.
Disclosure: This research was supported by grants P01 DK053369 and SCOR P50 DK64540 from the National Institute of Diabetes and Digestive and Kidney Diseases.
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