Five Days of LEVAQUIN® (levofloxacin) as Effective as 10 Days of Ciprofloxacin in Complicated Urinary Tract Infections and Acute Pyelonephritis

Data presented today at a major medical meeting found that LEVAQUIN® (levofloxacin) 750 mg tablets administered once-daily for five days is as effective as standard therapy of ciprofloxacin (400/500 mg) for 10 days for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP)1.

Ortho-McNeil, Inc., the company that markets LEVAQUIN® in the U.S., presented the data during a scientific session at the annual meeting of the American Urological Association (AUA), held here this week.

Each year, urinary tract infections account for more than eight million physician visits. They occur in the kidneys, ureters, bladder or the urethra and often are recurrent, resulting in treatment with several courses of antibiotics. Complicated UTIs occur nearly as frequently in men as in women and often occur in people who are susceptible to bacterial infections because of a weakened immune system. Complicated UTIs also may be caused by structural or functional difficulties that interfere with the flow of urine, such as kidney stones.

Pyelonephritis is an infection of one or both kidneys caused by bacteria. It is estimated that more than 250,000 Americans suffer from AP every year, with 10 to 30 percent of cases resulting in hospitalization.

“A short course of five, once-daily doses of LEVAQUIN® 750 mg is as effective as 10 twice-daily doses of ciprofloxacin in treating complicated urinary tract infections and acute pyelonephritis,” said Norman R. Rosenthal, MD, vice president, Medical Affairs, on behalf of Ortho-McNeil, Inc. “These findings will be important to the health care professionals that treat patients with these conditions.”

The multi-center, double-blind, randomized study of 1,109 patients with either cUTI or AP was designed to assess the efficacy and safety of LEVAQUIN® (750 mg QD / five days) versus ciprofloxacin (400/500 mg BID / 10 days). Endpoints evaluated microbiological eradication, clinical response and safety.

The microbiological eradication rates in the AP and cUTI subjects were comparable in both treatment groups, including subjects with various other complicating factors such as bacteremia, a form of blood infection. Clinical results, as defined by resolution of or improvement in urinary symptoms, were similar for both the LEVAQUIN® (750 mg QD / five days) and the ciprofloxacin (400/500 mg BID / 10 days) groups. The most commonly reported adverse events with both treatments were nausea, headache, and diarrhea, however, there were no significant differences in the frequency of these events between the two groups. LEVAQUIN® was generally well tolerated.

Since its U.S. introduction in 1996, LEVAQUIN® has gained widespread use in the treatment of adults for a variety of bacterial infections caused by susceptible pathogens2, including: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections (mild to moderate), chronic bacterial prostatitis, complicated and uncomplicated urinary tract infections (mild to moderate) and acute pyelonephritis (mild to moderate). LEVAQUIN® is available in 250 mg, 500 mg and 750 mg doses in both oral and I.V. formulations. The safety profile of LEVAQUIN® is similar across doses.