Back to Scientific Program
Back to Annual Meeting
Efficacy and Safety Of Proquin® XR VS. Immediate-Release Ciprofloxacin [C-IR] In the Treatment Of Acute Cystitis
Neal D. Shore*
Grand Strand Urology/Carolina Urologic Research Center, Myrtle Beach, SC
Introduction: ProQuin® XR (P-XR) is a novel once-daily prolonged-release formulation of ciprofloxacin that delivers a controlled 500-mg dose to the upper gastrointestinal (GI) tract. The objective of this study was to compare the efficacy and safety of P-XR 500mg QD with immediate release ciprofloxacin (C-IR) 250mg BID, each administered orally for 3 days, in the treatment of acute cystitis in women.
Methods: Eligible women with symptoms of acute cystitis and a positive pretreatment urine culture (≥105 CFU/mL) were enrolled in this randomized, double-blind trial. Patients were assessed at a Test-of-Cure (TOC) visit (4 to 11 days post-treatment) and a Late Post-Treatment (LPT) visit (4 to 6 weeks post-treatment) for microbiological and clinical outcomes, and safety.
Results: The primary efficacy endpoint, microbiological eradication rate at TOC, in the P-XR group (254/272, 93.4%) was non-inferior to the C-IR group (225/251, 89.6%) (95% CI of difference: -0.99%, 8.59%). Clinical cure rates were also equivalent. The frequencies of nausea and diarrhea were significantly lower in the P-XR group than in the C-IR group (nausea: P-XR, 0.6%; C-IR, 2.2%; p=0.033; diarrhea: P-XR, 0.2%; C-IR, 1.4%; p=0.037).
Conclusions: P-XR was as efficacious as C-IR in the treatment of acute cystitis, but with reduced GI side effects, including a 7-fold reduction in diarrhea and a 3-fold reduction in nausea.
Financial support for this study was provided by Depomed, Inc., Menlo Park, CA.
Back to Scientific Program
Back to Annual Meeting
