Healthcare Industry News: Ortho-McNeil
News Release - May 19, 2007
Five Days of LEVAQUIN(R) as Effective as 10 Days of Ciprofloxacin in Complicated Urinary Tract Infections and Acute PyelonephritisANAHEIM, Calif., May 19 (HSMN NewsFeed) -- 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).
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 healthcare 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 pathogens, 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.
Important Safety Information
The most common drug-related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%). The safety and efficacy of LEVAQUIN in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. LEVAQUIN is contraindicated in persons with a history of hypersensitivity to LEVAQUIN, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions, as well as some of unknown etiology have been reported in patients receiving therapy with quinolones, including LEVAQUIN.
These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
As with other quinolones, LEVAQUIN should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.
Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including LEVAQUIN, during and after therapy. This risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. The quinolone should be discontinued in patients experiencing pain, inflammation, or rupture of a tendon.
Some quinolones, including LEVAQUIN, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. LEVAQUIN should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.
Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx®* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after LEVAQUIN administration.
For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full Prescribing Information on http://www.levaquin.com.
PriCara (TM), Unit of Ortho-McNeil, Inc.
Ortho-McNeil, Inc. is headquartered in Raritan, N.J. PriCara, Unit of Ortho-McNeil, Inc. provides innovative, high-quality, prescription medicines, education and resources for primary healthcare providers and their patients in the areas of pain, gastrointestinal and infectious diseases. For more information about the company, please visit http://www.PriCara.com.
*Videx is a registered trademark of Bristol-Myers Squibb Company
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