Cephalosporin antibiotic inferior to ciprofloxacin for cystitis

February 15, 2012

Short-term use of the cephalosporin antibiotic cefpodoxime proxetil (Vantin) for the treatment of women with uncomplicated cystitis did not meet criteria for noninferiority for achieving clinical cure compared with ciprofloxacin (Cipro, Proquin), say researchers from the University of Miami Miller School of Medicine.

Short-term use of the cephalosporin antibiotic cefpodoxime proxetil (Vantin) for the treatment of women with uncomplicated cystitis did not meet criteria for noninferiority for achieving clinical cure compared with ciprofloxacin (Cipro, Proquin), say researchers from the University of Miami Miller School of Medicine.

"We wanted to see if cefpodoxime was comparable to the gold standard, but it wasn’t," said first author Thomas M. Hooton, MD. "It didn’t perform as well as we would have liked, so we do not see it as a good alternative to ciprofloxacin."

The clinical trial by Dr. Hooton and colleagues, published in JAMA (2012; 307:583-9), was designed to assess whether cefpodoxime would have clinically acceptable efficacy and tolerance compared with ciprofloxacin. The study, conducted from 2005 to 2009, included 300 women ages 18 to 55 years with acute uncomplicated cystitis. Outcomes were assessed at 5 to 9 days and 28 to 30 days after completion of therapy.

Intent-to-treat and per-protocol analyses were performed. Patients were randomized to oral ciprofloxacin, 250 mg twice daily for 3 days, or oral cefpodoxime, 100 mg twice daily for 3 days. Overall clinical cure was defined as not requiring antimicrobial treatment during follow-up through the 30-day follow-up visit.

The authors found that the overall clinical cure rate with the intent-to-treat approach was 93% for ciprofloxacin compared with 82% for cefpodoxime. The test of noninferiority was not statistically significant. In an alternative intent-to-treat analysis in which patients who were lost to follow-up were considered to have not responded to treatment, the clinical cure rate was 83% for ciprofloxacin compared with 71% for cefpodoxime.

The clinical cure rate at the first follow-up visit (average, 5 days after treatment) was 93% for ciprofloxacin compared with 88% for cefpodoxime. The microbiologic cure rate at the first follow-up visit (average, 5 days after treatment) was 96% for ciprofloxacin compared with 81% for cefpodoxime.

The authors said the study data do not support the use of cefpodoxime as a first-line fluoroquinolone-sparing antimicrobial for acute uncomplicated cystitis.

Dr. Hooton has been a consultant for Pinnacle Pharmaceuticals, Pfizer, Inc., and Alita Pharmaceuticals.

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