Study Results Show Safety and Efficacy Profile of Once-Daily Cipro XR is Comparable to Conventional Cipro in Treating Complicated Urinary Tract Infections

CHICAGO -- Study results announced this week show that once-daily 1000mg Cipro XR (ciprofloxacin* extended-release tablets) was comparable in safety and efficacy to conventional Cipro (ciprofloxacin HCl) in the treatment of complicated urinary tract infections (UTIs), including acute uncomplicated pyelonephritis (AUP).

The study, which evaluated 1000mg Cipro XR taken once-daily and 500mg conventional Cipro taken twice daily for 7-14 days, demonstrated clinical cure in 97 percent of Cipro XR patients compared with 94 percent of patients receiving conventional Cipro. The results of the US and Canadian multi-center clinical trial were presented at the annual meeting of the American Urological Association (AUA) by Dr. David Talan, Professor of Medicine, UCLA School of Medicine and the lead investigator of the study. Cipro XR 1000mg is currently under review by the U.S. Food and Drug Administration (FDA).

"For many years, fluoroquinolones have been recommended empirical therapy for treatment of complicated UTIs. Research has documented that ciprofloxacin has high activity against E. coli, the pathogen that causes the majority of these infections," said Dr. Talan. "This new extended release formulation of ciprofloxacin may provide a convenient once-daily treatment option for these difficult-to treat infections."

The once-daily formulation was developed using a bilayer matrix of the active ingredient ciprofloxacin. It enables the rapid release of ciprofloxacin, which distributes to the serum and tissues within hours. This is followed by a second extended release of the active ingredient, which produces 24-hour urine concentrations.

Urinary tract infections are a serious health problem, accounting for millions of physician visits each year. UTIs are most often caused by bacteria and are frequently treated with antibiotics, such as fluoroquinolones.

Complicated UTI can be defined as a symptomatic infection with significant bacteria in the urine and associated with structural or functional urinary tract abnormality. Such abnormalities or risk factors predisposing patients to complicated UTIs are numerous, including stones, neurogenic bladder disorder, urinary tract instrumentation, catheterization, and metabolic conditions such as diabetes. Complicated UTI is often associated with recurrent infections and frequently involves multi-resistant microorganisms and can be associated with increased morbidity, mortality and length of stay in hospitalized patients.

AUP is an upper urinary tract infection involving the kidney and renal pelvis and most commonly results from inadequately treated cystitis. Every year in the United States, about 250,000 women develop pyelonephritis, and 100,000 are hospitalized.

The prospective, randomized, double-blind, North American multicenter clinical trial included 435 patients (343 with cUTI and 92 with AUP) and compared 1000mg once-daily Cipro XR to a twice-daily 500 mg dose of conventional Cipro. Adult male and female patients were evaluated based on the presence of cUTI (at least one clinical sign of a UTI and one underlying condition, such as use of a catheter), or AUP (symptoms of fever, chills and flank pain). Evaluation was based on bacteriologic and clinical outcomes.

For cUTI and AUP combined, bacteriological eradication (evaluated 5 to 11 days post-therapy) was achieved in 89 percent of patients treated with once-daily Cipro XR and 85 percent of patients treated with conventional twice-daily Cipro. In addition, clinical cure (evaluated 5 to 11 days post-therapy) was observed in 97 percent of patients treated once a day with Cipro XR 1000mg, compared with 94 percent of patients receiving the traditional Cipro 500mg twice daily. Eradication of E. coli, the most predominant organism causing infections in study patients, was 97 percent for each group (evaluated 5 to 11 days post-therapy). Rates of drug-related adverse events were similar in both groups. The most common adverse events for Cipro XR 1000mg occurring in at least 2 percent of patients were nausea (3 percent) and diarrhea (2 percent).

Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the healthcare and medical products industry.

* as ciprofloxacin(1) and ciprofloxacin hydrochloride

(1) Does not comply with the loss on drying test and residue on ignition

test of the USP monograph.

Source: Bayer Pharmaceuticals Corporation