• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Study Describes New Once-Daily Treatment Regimen for Complicated Intra-Abdominal Infections

Posted on: Monday, 1 November 2004, 09:00 CST

WASHINGTON, Nov. 1 /PRNewswire/ -- A new study shows that sequential (I.V./P.O.) monotherapy with Avelox(R) (moxifloxacin HCl) once-daily for complicated intra-abdominal infections (cIAI) was as effective as therapy with I.V. piperacillin-tazobactam four-times daily followed by oral amoxicillin-clavulanate twice-daily, a widely-used therapy for this type of infection.

The study, presented at the 44th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), also showed that Avelox patients had a higher clinical cure rate (81.5 percent) than comparator therapy patients (54.8 percent) when their infection was acquired in a hospital setting. Higher cure rates with Avelox were also observed in infections caused by B. fragilis (85.4 percent vs. 72.0 percent comparator therapy), one of the most common anaerobic bacteria causing these infections.(1)

Intra-abdominal infections cause significant problems in clinical practice and consume substantial hospital resources, including emergency department services, operating room time, laboratory services and antibiotic therapy. Patient outcomes are heavily influenced by rapid diagnosis, appropriate intervention and by the timeliness and efficacy of antibiotic therapy.(2) Current antibiotic treatment for IAI typically involves use of two or more antibiotics in combination (61% of all patient uses) to ensure adequate antibacterial coverage, including activity against anaerobic bacteria.(3)

"In this Phase III study of complicated intra-abdominal infections, once-daily sequential therapy with Avelox provided efficacy comparable to standard daily therapy with piperacillin-tazobactam four-times daily followed by amoxicillin/clavulanate twice daily," said Joseph Solomkin, MD, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio, and lead author of the cIAI treatment guidelines released by the Infectious Diseases Society of America (IDSA) last year. "We are encouraged by these data that Avelox monotherapy may prove to be a promising treatment option for complicated intra-abdominal infections."

In this prospective, double-blind trial, 681 patients were enrolled. Six hundred fifty-six (328 patients received Avelox, 328 received comparator therapy) were included in the safety population and 379 patients (182 Avelox and 197 comparator therapy) were included in the efficacy population. Patients were stratified by disease severity, and then randomized to receive I.V. to oral Avelox (400 mg every 24 hours) or I.V. piperacillin-tazobactam (3.0/0.375g every 6 hours) to oral amoxicillin-clavulanate (800mg/114mg every 12 hours) for five to 14 days. Clinical cure and bacteriologic eradication rates were recorded at the Test-of-Cure (TOC) visit at 25-50 days post-therapy.

In patients valid for efficacy, clinical cure rates (79.7 percent Avelox vs. 78.2 percent comparator therapy) and bacteriologic eradication rates (77.9 percent Avelox vs. 77.4 percent comparator therapy) were similar. While clinical cure rates were higher in Avelox patients with B. fragilis (85.4 percent vs. 72.0 percent comparator therapy) and hospital-acquired (81.5 percent vs. 54.8 percent comparator therapy) infections, outcomes were similar in patients with intra-abdominal abscesses (76.3 percent Avelox vs. 77.6 percent comparator therapy), in patients with community-acquired infections (79.4 percent Avelox vs. 82.5 percent comparator therapy) and for patients with infections caused by E. coli bacteria (76.7 percent Avelox vs. 76.9 percent comparator therapy).

Adverse events were similar in both Avelox and comparator therapy groups. The three most common drug-related adverse events were diarrhea (5 percent Avelox vs. 8 percent comparator therapy), nausea (5 percent Avelox vs. 4 percent standard therapy), and an increase in gamma glutamyl transferase (2 percent Avelox vs. 2 percent comparator therapy). Discontinuation (10.4 percent Avelox vs. 8.5 percent comparator therapy) due to an adverse event and death (1.8 percent Avelox vs. 2.1 percent comparator therapy) were comparable in both groups.

About Complicated Intra-abdominal Infections (cIAI)

Complicated intra-abdominal infections extend beyond the inside of the abdominal organs (such as the stomach and pancreas) into the cells of the abdominal wall and are associated either with abscess formation or inflammation of abdominal tissue, or peritonitis. These infections may occur on their own or can also occur following trauma to the abdominal organs (e.g., appendicitis, pancreatitis) and require surgery or I.V. treatment to be resolved.(4)

About Avelox

Avelox is approved to treat: Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; and Uncomplicated Skin and Skin Structure Infections (uSSSI) caused by Staphylococcus aureus or Streptococcus pyogenes.

* 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.

Important Safety Considerations

Avelox is a prescription medication that is generally well tolerated. The most common side effects, which are usually mild, include nausea, diarrhea, and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness.

You should not take Avelox if you have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. You should avoid taking Avelox if you have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol.

If you are pregnant or planning to become pregnant while taking Avelox, talk to your healthcare provider before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Avelox is not recommended for children under the age of 18 years. Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. You should take Avelox either four hours before or eight hours after taking these products.

Be sure to inform your healthcare provider of any medical conditions you have and all prescription and non-prescription medications or supplements you are taking. If you have any concerns about your medication or side effects, please contact your healthcare provider.

For Avelox prescribing information and indicated organisms, log on to http://www.aveloxusa.com/ or call Bayer Clinical Communications at 800-288-8371.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG.

Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) Solomkin, J, et al. Guidelines for the Selection of Anti-infective

Agents for Complicated Intra-abdominal Infections. Clinical

Infectious Diseases 2003;37:997-1005

(2) Solomkin, J, et al. Guidelines for the Selection of Anti-infective

Agents for Complicated Intra-abdominal Infections. Clinical

Infectious Diseases 2003;37:997-1005

(3) AMR 2003

(4) Solomkin, J, et al. Guidelines for the Selection of Anti-infective

Agents for Complicated Intra-abdominal Infections. Clinical

Infectious Diseases 2003;37:997-1005

Bayer Pharmaceuticals Corporation

CONTACT: Staci Gouveia of Bayer Pharmaceuticals Corporation,+1-203-812-6152, or Fax, +1-203-812-5824

Web site: http://www.bayerpharma.com/http://www.aveloxusa.com/

Source: PRNewswire

More News in this Category