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Extended-release Cipro found effective for UTI. (Study of New Formulation).

SAN DIEGO--Extended-release ciprofloxacin appears to be as effective and safe as the conventional twice-daily formulation for the treatment of uncomplicated urinary tract infections in women, Dr. Ernie Riffer reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

"It decreased the number of phone calls," noted Dr. Riffer, an internist in group practice in Phoenix, Ariz.

The new formulation provides an immediate release of 35% of the medication while prolonging release of the remaining 65%. Bayer Corp. filed a new drug application for Cipro XR with the Food and Drug Administration in March 2002.

Clinical cure of uncomplicated urinary tract infection was achieved at days 4-11 among 95% of 198 women who were treated with 500 mg of extended-release ciprofloxacin once daily for 3 days, compared with 93% of 220 women treated with 250 mg of immediate-release ciprofloxacin twice daily for 3 days. At a follow-up visit 25-50 days after the end of therapy, continued clinical cure rates were 89% for extended-release and 87% for twice-daily ciprofloxacin, he said during the conference, also sponsored by the American Society for Microbiology.

At baseline, 99% of all isolates--82% of which were Escherichia coli--were susceptible to ciprofloxacin. Bacteriologic eradication was achieved in 94% of both treatment groups at days 4-11, with 97% of E. coli strains eradicated in both groups. At the later visit between days 25 and 50, bacteriologic eradication persisted in 86% of the extended-release group and 81% with the immediate-release formulation. Recurrence was 8% for both groups.

Drug-related adverse events, including headache and vaginitis, were reported by 10% of the extended-release patients and 9% of the other group. No serious drug-related adverse events were reported; one patient in the extended-release group stopped the drug due to a side effect.
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Author:Tucker, Miriam E.
Publication:OB GYN News
Date:Nov 15, 2002
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