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Head-To-Head Fluoroquinolone Study Shows Quicker Recovery With Moxifloxacin Compared to Levofloxacin

KENILWORTH, N.J., Jan. 24 /PRNewswire-FirstCall/ -- Significantly more elderly patients treated with AVELOX(R) (moxifloxacin HCl) for community-acquired pneumonia (CAP) recovered at days 3 to 5 of a 7 to 14 day course of treatment than those treated with LEVAQUIN (levofloxacin), according to results of a clinical study published in the current issue of Clinical Infectious Diseases.(1) The first comparative, head-to-head evaluation of two fluoroquinolone antibiotics in hospitalized elderly CAP patients showed that 97.9 percent of AVELOX patients recovered at days 3 to 5 compared to 90.0 percent of LEVAQUIN patients (P=0.01). There was no significant difference between the two treatments with regard to cardiac safety, the primary endpoint of the study, or clinical cure rates 5 to 21 days after the end of treatment, the primary efficacy endpoint.

Additional analyses examined cure rates across CAP severity and age subgroups, including mild to moderate CAP, severe CAP, CAP in patients 65-74 years of age, and CAP in patients 75 years of age or older. Patients treated with AVELOX achieved a cure rate of 90 percent or greater in all CAP severity and age subgroups. The rates of investigator-reported drug-related adverse events in the study were similar for both treatment regimens.

The clinical study, called CAPRIE (Community-Acquired Pneumonia Recovery In the Elderly), is one of only a few studies that have specifically evaluated CAP treatment among elderly (age 65 or older) and very elderly (age 75 or older) patients. These patients are 60 percent more likely to contract CAP than the general population.(2)

"The incidence of pneumonia increases with age and elderly pneumonia patients are a vulnerable patient population that faces a high mortality rate when they enter a hospital," said Dr. Antonio Anzueto, lead study author and associate professor of medicine, University of Texas Health Science Center, San Antonio. "The CAPRIE study findings not only reinforce that AVELOX is an effective and safe treatment option for elderly patients with CAP, but also show that more patients taking AVELOX recovered at days 3 to 5 compared to patients taking LEVAQUIN."

Each year, there are nearly one million cases of community-acquired pneumonia among the elderly in the United States and among those age 85 or older, at least 1 in 20 have to be hospitalized.(3,4) The disease is the fifth leading cause of death in the elderly and research has shown that the appropriate and timely administration of antibiotics to elderly CAP patients may lead to decreased mortality and faster hospital discharge.(5)

Study Design
The CAPRIE study was a prospective, randomized, controlled, double-blind, double-dummy, comparative study conducted at 47 centers across the United States. Patients were stratified by CAP severity before randomization to I.V./oral AVELOX 400 mg once daily or I.V./oral LEVAQUIN 500 mg once daily for seven to 14 days. The study enrolled 394 patients, of which 281 were valid for the primary efficacy analysis. Most patients had multiple co-morbidities, including chronic obstructive pulmonary disease (COPD), cardiac disease and diabetes, and 16 percent of patients had severe CAP.

About Community-Acquired Pneumonia (CAP)
Community-acquired pneumonia affects 5.6 million adults in the United States annually, resulting in nearly two million cases of hospitalization.(6,7) It is the fifth leading cause of death among people older than 65 years, and a larger percentage of these patients have frequent co-morbidities and require hospitalization and longer hospital and intensive care unit (ICU) stays.(8,9) The cost of treating CAP patients is estimated at $10 billion per year, with 92 percent of those costs spent on hospitalized care.(10) Community-acquired pneumonia is a particular concern for seniors and people with chronic illnesses or impaired immune systems, although it also affects young and healthy people. The elderly population is 60 percent more likely than the general population to be affected by CAP.(11)

About AVELOX
AVELOX, available in tablet and I.V. formulations, was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering- Plough. AVELOX offers patients a once-daily dosing regimen that does not require dosage adjustment when switching from I.V. to oral therapy. AVELOX patients suffering from renal impairment do not need to have their dosage adjusted.

AVELOX is approved to treat: Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis; Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae; Uncomplicated Skin and Skin Structure Infections (uSSSI) caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes; Complicated Skin and Skin Structure Infections (cSSSI) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae; and Complicated Intra-Abdominal Infections (cIAI) including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.

* MDRSP, multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotic classes: penicillin (MIC greater than or equal to 2 mcg/mL), second generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

SAFETY INFORMATION about AVELOX
AVELOX is generally well tolerated, with adverse events being similar to standard therapy. The most common side effects caused by AVELOX, which are usually mild, include dizziness, nausea and diarrhea. Patients should be careful about driving or operating machinery until they are sure that AVELOX is not causing dizziness. Patients should inform a health care professional of other side effects.

Patients who have ever had an allergic reaction to AVELOX or any of the other group of antibiotics known as "quinolones," such as levofloxacin should avoid taking AVELOX.

Patients who have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat should avoid taking AVELOX. These medications include quinidine, procainamide, amiodarone and sotalol.

AVELOX is not for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. AVELOX is not for children under the age of 18 years.

Convulsions have been reported in patients receiving quinolone antibiotics. Patients should be sure to let their physician know if they have a history of convulsions.

Many antacids and multivitamins may interfere with the absorption of AVELOX and may prevent it from working properly. Patients should take AVELOX either 4 hours before or 8 hours after taking these products.

Please see full prescribing information for AVELOX available at www.AVELOXUSA.com.

Source: Schering-Plough Corporation

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