Ortho-McNeil, Inc. New Study Supports Use of LEVAQUIN as a Guideline-Concordant Antibiotic for the Treatment of Community-Acquired Pneumonia (CAP)

Published: Oct 28, 2008

WASHINGTON, Oct. 27 /PRNewswire/ -- Ortho-McNeil presented interim results from a retrospective analysis examining medical resource utilization during hospitalization of adult patients for community-acquired pneumonia (CAP). The results showed that patients treated with LEVAQUIN (levofloxacin) were observed to have had a shorter average length of stay (LOS) and shorter average duration of intravenous antibiotic therapy (LOIV) compared to patients treated with ceftriaxone plus azithromycin. The study included data from 949 hospitalized (non-ICU) adult patients collected from four U.S. hospitals from 2005-2007.

The 2007 Infectious Disease Society of America (IDSA) / American Thoracic Society (ATS) Antibiotic Guidelines for the management of CAP with Guideline-Concordant (GC) antibiotics recommends that clinicians choose among concordant regimens for the treatment of CAP in a non-ICU setting with a fluoroquinolone, such as LEVAQUIN, or combination treatment with a beta-lactam plus a macrolide. The interim data supports the use of LEVAQUIN in the treatment of CAP as recommended by the Guidelines.

The interim study results were presented at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) / Infectious Disease Society of America (IDSA) 46th Annual meeting in Washington, D.C.

"For many years, LEVAQUIN has been an effective treatment option for patients affected by community-acquired pneumonia and a variety of other bacterial infections," said Dr. Christopher Frei, lead author and Assistant Professor, The University of Texas at Austin. "These interim results support the use of LEVAQUIN as a guideline-concordant antibiotic therapy for treatment of hospitalized (non-ICU) patients with CAP."

Data were collected from hospitalized adult patients with a principal CAP diagnosis and positive chest x-ray. Direct ICU admissions and cases contracted in a healthcare setting were excluded. Patients who received antibiotics recommended in the guideline (n=484) were treated with either 750mg daily dose of LEVAQUIN or 1mg of ceftriaxone plus 500mg of azithromycin. Patients with CAP (n= 465) who were treated with an antibiotic therapy that deviated from the guidelines demonstrated greater mortality rates (1.7% vs. .2%), average LOS (6.3 vs. 4.9 days) and average duration of LOIV (5.1 vs. 4.1 days) compared to patients treated with an antibiotic therapy recommended in the guidelines. Baseline differences were noted between these groups and the group who received guideline-recommended therapy were older and had more comorbidities, more corticosteroid use and less pre-admission antibiotic use.

Among all CAP patients who received antibiotic therapy recommended in the IDSA/ATS Guidelines (n=484), those in the LEVAQUIN group (n=309) had statistically significant lower average LOS of 4.6 days versus 5.5 days for those in the ceftriaxone plus azithromycin group (n=175). Additionally, patients in the LEVAQUIN group had a shorter average duration of LOIV of 3.6 days versus 5.0 days for those treated with ceftriaxone plus azithromycin. Baseline differences noted between these groups include higher rates of chronic heart failure and pre-admission antibiotic use in the patients who received ceftriaxone plus azithromycin.

It should be recognized that costs and resource utilization are of importance when considering certain healthcare decisions. These results may be helpful to hospital decision makers who are responsible for selecting drugs as treatment options for CAP in hospitalized patients.

LEVAQUIN IV is marketed to healthcare providers in the U.S. by Ortho-McNeil, division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Community-Acquired Pneumonia (CAP)

Community-acquired pneumonia (CAP) is pneumonia acquired in the outpatient or community setting and is a growing health concern, affecting more than 915,000 Americans over age 65 each year. Streptococcus pneumoniae (Pneumococcus) accounts for 16% to 60% of CAP and is the leading cause of the condition. Many patients who present with CAP (58 to 89%) have one or more chronic diseases, including: COPD, cardiovascular disease, neurological disease, diabetes or a history of substance abuse. Pneumonia is also the third most common cause for hospitalization in patients 65 and older and the seventh most frequent cause of death.


LEVAQUIN is indicated for adults with community-acquired pneumonia due to methicillin-susceptible S aureus, S pneumoniae (including multidrug-resistant S pneumoniae [MDRSP]), H influenzae, H parainfluenzae, K pneumoniae, M catarrhalis, C pneumoniae, L pneumophila, or M pneumoniae. MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC greater than or equal to 2 micrograms/mL), 2nd generation cephalosporins, eg, cefuroxime, macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Efficacy of the LEVAQUIN 750 mg/once-daily/5-day regimen has been demonstrated for community-acquired pneumonia caused by S pneumoniae (excluding MDRSP), H influenzae, H parainfluenzae, M pneumoniae, or C pneumoniae.

Important Safety Information

Fluoroquinolones, including LEVAQUIN(R), are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants. Tendon ruptures that required surgical repair have been reported in patients receiving fluoroquinolones, including levofloxacin, during and after therapy; cases occurring up to several months after completion of therapy have been reported. If patient is determined to have tendinitis or tendon rupture, discontinue therapy.

Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin or other quinolone antibacterials. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions and some of unknown etiology, have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may include effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure, and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. Discontinue levofloxacin at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity.

Severe hepatotoxicity (including acute hepatitis and fatal events) not associated with hypersensitivity has also been reported. Discontinue immediately if signs and symptoms of hepatitis develop.

Central nervous system effects, including convulsions, confusion, anxiety, depression, and insomnia, may occur after the first dose. As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders that may predispose them to seizures or lower the seizure threshold.

Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including levofloxacin. If diarrhea occurs, evaluate for CDAD and treat appropriately.

Rare cases of peripheral neuropathy have been reported in patients receiving quinolones, including levofloxacin. Discontinue if symptoms of neuropathy occur to prevent the development of an irreversible condition.

Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. Levofloxacin 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.

Moderate to severe photosensitivity/phototoxicity reactions can be associated with the use of quinolones after sun or UV light exposure. Blood glucose disturbances have been reported with use of quinolones, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin.

Safety and efficacy in pregnant women and nursing mothers have not been established. The risk-benefit assessment indicates that levofloxacin is only appropriate in pediatric patients for treatment of inhalational anthrax (post-exposure). The safety in pediatric patients treated for more than 14 days has not been studied.

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 not be taken within 2 hours before or after levofloxacin administration.

The most common adverse drug reactions (greater than or equal to 3%) in US clinical trials were nausea, headache, diarrhea, insomnia, constipation, and dizziness.

For additional information on Warnings, Precautions, Adverse Reactions, Drug Interactions, and Use in Specific Populations, including Boxed Warning please visit www.LEVAQUIN.com or click on http://www.levaquin.com/levaquin/isi_fpi.html.

* Videx is a registered trademark of Bristol-Myers Squibb Company.

About Ortho-McNeil

Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is committed to providing innovative, high-quality prescription medicines and resources in the areas of bacterial infection and cardiovascular disease for healthcare providers and their patients in hospitals and other care facilities. For more information, visit www.ortho-mcneil.com.

CONTACT: Media: Amy Firsching, +1-908-218-7583, IR: Lesley Fishman,
+1-732-524-3922, or Louise Mehrotra, +1-732-524-6491

Web site: http://www.LEVAQUIN.com/

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