If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Avelox as Effective as Multi-Dose Combination Therapy for Intra-Abdominal Infections Results published in current Annals of Surgery KENILWORTH, NJ -- July 25, 2006 -- Schering-Plough Corporation today reported that monotherapy with the once-daily, broad-spectrum antibiotic Avelox (moxifloxacin HCl) was as effective and well tolerated as a standard multi-dose combination antibiotic regimen in the treatment of patients with complicated intra-abdominal infections (cIAI), according to results of a study involving 681 patients published in the current issue of the Annals of Surgery.(1) Avelox, the only marketed fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) as monotherapy to treat cIAI, was shown to be effective at eradicating the most common bacteria that cause cIAI, including E. coli and B. fragilis. In the study, patients who took 400 mg once daily of Avelox intravenous (I.V.) followed by oral monotherapy achieved similar clinical cure rates (80%) at the test-of-cure visit (the primary efficacy endpoint) as patients who took a standard regimen of I.V. piperacillin-tazobactam followed by oral amoxicillin-clavulanate (78%). Importantly, Avelox demonstrated a significantly higher cure rate of 82% – compared to 55% for the combination therapy – among patients who acquired their cIAI in a hospital setting (including both mild-to-moderate and more severe hospital-acquired infections). Hospital-acquired infections are often caused by more resistant bacteria than community-acquired infections. Clinical cure rates for patients with community-acquired infections were similar between the two treatment groups. The incidence of adverse events in the study due to any cause was similar for the two treatment groups, with the majority being mild or moderate in nature. The most common adverse events were nausea, hypokalemia, abdominal pain and constipation. The incidence of drug-related serious adverse events or premature discontinuation due to adverse events was similar for the two treatment groups. "The results of this study are important because complicated intra-abdominal infections are typically caused by mixed bacteria and require both surgery or drainage of the infection site and broad-spectrum antibiotic therapy for effective treatment," said Mark Malangoni, MD, lead study investigator and Professor of Surgery at Case Western Reserve University School of Medicine and Surgeon-in-Chief at MetroHealth Medical Center in Cleveland. "Avelox has demonstrated potent activity against the bacteria most common in these infections and is a safe and effective treatment. It also can be continued as a once-daily tablet, which is convenient for patients." Avelox is indicated to treat polymicrobial cIAI infections, including infections caused by mixed aerobic and anaerobic bacteria (bacteria that thrive without oxygen) commonly seen in patients with cIAI.(2,3) "One fixed dose of Avelox offers physicians a convenient treatment option with no dose adjustment required as symptoms improve and patients transition from intravenous (hospital-based) to oral therapy," said Joseph S. Solomkin, MD, Professor in the Department of Surgery and Director of Research of the Division of Trauma/Critical Care at the University of Cincinnati College of Medicine, and a leading expert in the field. "The key benefit of staying with the same agent is the knowledge that the patient responded to it intravenously and can continue with the oral form when they leave the hospital." Complicated intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue. The biggest challenge to effective cIAI treatment is early recognition of the problem; the sooner the infection is diagnosed, the greater the chance that the physician will prescribe an effective treatment.(4) In the absence of effective cIAI therapy, treatment failure and mortality rates increase. Clinical practice guidelines recommend that antimicrobial therapy should begin as soon as infection is suspected, before an exact diagnosis is confirmed.(5) There are approximately 3.5 million annual cases of cIAI in the United States.(6) About the Study A total of 656 patients were included in the intent-to-treat analysis and of these 379 were found valid to assess efficacy (183 Avelox/196 piperacillin–tazobactam). Patient baseline medical characteristics were similar for the two treatment groups. The duration of combined I.V./oral treatment in the study was 5–14 days. This study served as the basis for FDA approval of Avelox for the treatment of cIAIs in November 2005. About Complicated Intra-Abdominal Infections (cIAI) Generally, cIAI are acquired when the integrity of the gastrointestinal (GI) tract is affected as a result of previous surgery, intrinsic disease or trauma. The leakage of bacteria from within the GI tract into adjacent tissues results in infection. In the case of post-surgical infections, cIAI are caused by nosocomial bacteria specific to the surgical site and to the specific hospital and unit. About Avelox Avelox is approved for use in adult patients (18 years of age and older) for the treatment of: 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 S. pneumoniae (including multi-drug resistant strains*), H. influenzae, M. catarrhalis, methicillin-susceptible S. aureus, K. pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae; uncomplicated skin and skin structure infections (uSSSI) caused by methicillin-susceptible S. aureus or S. pyogenes; complicated skin and skin structure infections (cSSSI) caused by methicillin-susceptible S. aureus, E. coli, K. pneumoniae or Enterobacter cloacae; and complicated intra-abdominal infections (cIAI) including polymicrobial infections such as abscesses caused by E. coli, Bacteroides fragilis, S. anginosus, S. constellatus, E. faecalis, Proteus mirabilis, Clostridium perfringens, B. 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 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" 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. 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. REFERENCES:
SOURCE: Schering-Plough
|
