*Five Days Of LEVAQUIN(R) As Effective As 10 Days Of Ciprofloxacin In Complicated Urinary Tract Infections And Acute Pyelonephritis Five Days Of LEVAQUIN(R) As Effective As 10 Days Of Ciprofloxacin In Complicated Urinary Tract Infections And Acute Pyelonephritis
22 May 2007
Data presented Saturday at a major medical meeting found that LEVAQUIN(R) (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 last 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(R) (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
Ortho-McNeil, Inc.
http://www.PriCara.com∞
http://www.medilexicon.com/medicalnews.php?newsid=71635∞

*Researcher Makes Major Biofilm Dispersion Breakthrough Researcher Makes Major Biofilm Dispersion Breakthrough
16 Oct 2006
A Binghamton University biologist's discovery of a molecule that induces the dispersion of biofilms will likely mean a sea change in health care, manufacturing, shipping and pharmaceutics over the coming years.
David Davies has found and is in the process of synthesizing a compound that will cause biofilm colonies to disperse, thus leaving individual bacteria up to 1,000 times more susceptible to disinfectants, antibiotics and immune functions. It's a discovery that will most certainly drive worldwide biofilm research in new directions and that could help put some of the most virulent cells in all of nature out of business.
Biofilms are complex aggregations of bacteria marked by the excretion of a protective and adhesive matrix. They develop almost anywhere that water and solids, or solids and gases meet, which means they are virtually everywhere. They are formed when individual microorganisms embed themselves in a gelatinous structure of their own making. When traveling alone in planktonic form, most bacteria are of small consequence and generally easy to manage, even with antibacterial hand soaps. But when they form biofilms, bacteria seem to gain super powers.
In human terms the characteristic ?slime? of biofilms, which comprises organic polymers that can grow to several centimeters thick and cover large areas, spells all kinds of big trouble.
Biofilms, for instance, fog your contacts, help to rot your teeth, and cause a host of diseases from cystic fibrosis and ulcers to colitis and ear infections. They are a leading cause of hospital infections and non-healing wounds, and were even at the root this past summer of corrosion that forced the replacement of 16 miles of the Alaska pipeline. As a result of that incident, 400,000 barrels a day of production from the largest oil field in the United States was suspended. The indefinite shut down, at a cost equal to 8 percent of U.S. petroleum output, led to immediate increases in the price of crude oil, and drove up fuel oil and gas prices.
Annual worldwide costs of biofilm infection and remediation are in the high billions, even according to the most modest estimates, and they are costs borne by industries and consumers worldwide. Name a manufacturing process and biofilms are probably a serious and costly issue. They have even been discovered in pipes at factories producing prepadine, the anti-bacterial, iodine-based solution that doctors swab on patients to ?prep? them for surgery.
The small molecule Davies is working with appears to be one of the few known examples anywhere in nature of a communication signal that remains effective across species, family and phyla. In fact, though the evidence isn't yet in on that, Davies predicts the compound may also prove to have communicative effect even across bacterial kingdoms.
?I consider this the Holy Grail of research in biofilms,? he said. ?It's a new paradigm in the way we look at how bacteria regulate their behavior.?
An associate professor of biology at Binghamton University, Davies' prominence in his field was already secured when he showed in the late 1990s that bacteria ?talk to one another? through cell-to-cell communication and that such signaling is key to biofilm formation. Davies discovered the molecular medium of that communication in Pseudomonas aeruginosa, a biofilm-forming microorganism that is arguably the most common organism on the planet.
The dispersion autoinducer Davies is now investigating has shown itself to be effective in dispersing biofilms containing Pseudomonas aeruginosa, Streptococcus mutans (strep), Escherichia coli (E coli) and Staphylococcus aureus (staph) whether those bacteria exist in a pure or mixed-culture biofilm.
The dispersion-inducing molecule provokes genetic and physiological changes in the biofilm bacteria, causing them to disperse and return to a planktonic state. In lay terms, Davies has discovered at the very least how to tell four of the most problematic organisms around to pack up and get out of Dodge. And in so doing, the bacteria become easier to kill than the average mosquito. Davies' feels certain his discovery will dramatically change the way infections are treated.
?I think people will start inducing dispersion to disaggregate biofilms and, then, treat them concurrently, and with significantly greater efficacy, with antibiotics.?
He envisions his discovery first making its way to market as a topical treatment for cuts, lacerations and minor burns, perhaps even as an additive in adhesive bandages. But his major interest, and something he hopes to turn his attention towards in earnest in the coming year, is the area of non-healing wounds. Davies watched his diabetic great-aunt lose both of her feet to amputation after bacterial biofilm infections set in.
?If we can treat those kinds of wounds and clear up the infection, they will heal. We know that from wound debridement studies,? he said. ?I really think we can make a difference with these people, and if that was the only thing we did, it would be worth everything we're doing.?
http://www.medilexicon.com/medicalnews.php?newsid=54217∞