Prospective, randomised, double-blind study shows Avelox® monotherapy to be a highly effective, safe and convenient treatment option in vulnerable patient populations

Leverkusen, 06 September 2006 – Avelox® (moxifloxacin HCl) 400mg sequential intravenous to oral monotherapy given once a day is as effective as the potent combination of high-dose ceftriaxone plus high-dose levofloxacin in hospitalised patients with community-acquired pneumonia (CAP) according to new data presented at the 16th Annual Congress of the European Respiratory Society (ERS) in Munich, Germany.

Avelox® (moxifloxacin HCl) 400mg sequential intravenous to oral monotherapy given once a day is as effective as the potent combination of high-dose ceftriaxone plus high-dose levofloxacin in hospitalised patients with community-acquired pneumonia (CAP) according to new data presented at the 16th Annual Congress of the European Respiratory Society (ERS) in Munich, Germany.

In MOTIV, hospitalised patients received either 400mg IV/PO moxifloxacin once daily for seven to 14 days or the comparator regimen, a combination of IV ceftriaxone 2g once daily plus IV levofloxacin 500mg twice daily, followed by oral levofloxacin 500mg twice daily, for seven to 14 days. Clinical evaluation, cardiac events and chest x-rays were all assessed by independent data review committees. In terms of clinical cure at the test-of-cure visit, no significant difference was found in the two treatment groups regardless of disease severity or patient age. The cure rates at the test-of-cure in the per protocol population were 86.9% vs. 89.9% (p=NS) and in the intent-to-treat population 79.6% vs. 83.9% (p=NS). Additionally, both treatments were well tolerated, with similar adverse event profiles.

“The results of the MOTIV study are important because CAP is a particular concern for patients with chronic illnesses or impaired immune systems and is a common cause of hospitalisation worldwide,” said Dr. Antoni Torres, Professor of Pulmonology at the University of Barcelona and one of the MOTIV lead investigators. “CAP can critically affect older patients who may be struggling with existing health conditions such as heart disease and diabetes”, he added. “As a monotherapy given just once-a-day, these results reinforce that moxifloxacin is an effective, safe and convenient therapy for CAP patients with severe pneumonia treated in the hospital setting.”

Dr. Tobias Welte, from the Medizinische Hochschule Hannover in Germany, presented data from CAPNETZ summarising CAP statistics from Germany. It is estimated that about 800.000 people suffer annually from the disease and about a third of these need to be hospitalised. With a mortality rate of 6-8 % CAP is the 6th leading cause of death in Germany. Potent antibiotics are needed to kill the pathogens causing CAP and help patients recover quickly.

Moxifloxacin has also shown excellent efficacy in the treatment of other respiratory tract infections such as AECB (acute exacerbations of chronic bronchitis). This was reflected in the talk of Dr. Rob Wilson from the Royal Brompton Hospital London, who summarised findings of the MOSAIC trial. In a post-hoc analysis of this study published this year, key prognostic factors influencing patient outcomes in AECB were identified: The only factors which predicted a positive outcome were the choice of antibiotic treatment, in particular moxifloxacin whereas a poor outcome was predicted by patient age >65 years, frequent exacerbations, co-morbid cardiopulmonary disease, low forced expiratory volume and the need for bronchodilators. Future clinical trials should take these factors into account, emphasised Dr. Wilson.

Dr. Sanjay Sethi, Associate Professor in the Department of Medicine at State University of New York (SUNY), Buffalo, United States, took a closer look at the AECB patient and discussed current efforts to better define exacerbations and improve their outcome. He explained that exacerbations are inflammatory events, and that in 50% of AECB episodes, bacterial infection of the lower airways incites this inflammation. Therefore effective antibiotics are important in AECB therapy to not only hasten clinical resolution but also to eradicate bacteria and reduce airway inflammation. Use of fluoroquinolones with superior bacterial eradication like moxifloxacin can reduce the number of relapses by increasing the time interval between exacerbations and thus improve patients’ quality of life.

The presentations were given on Tuesday, 5 September 2006 at the symposium “Not all patients are the same – optimising the outcomes in respiratory tract infections” during the 16th Annual Congress of the European Respiratory Society and supported by an educational grant from Bayer HealthCare.

Full Speaker credentials:

• Rob Wilson, Head of Infection Firm at the Royal Brompton Hospital, London, United Kingdom
• Sanjay Sethi, Associate Professor in the Department of Medicine at the State University of New York (SUNY) at Buffalo School of Medicine and Biomedical Sciences, New York, United States
• Tobias Welte, Professor and Head of the Department of Pulmonary and Infectious Disease Medicine at the Medizinische Hochschule Hannover, Germany
• Antoni Torres, Professor (Pulmonology) at the Faculty of Medicine, University of Barcelona, Chief of the Pulmonary Department and Senior Consultant at the Hospital Clinic, Barcelona, Spain

About Avelox
In Europe , Avelox® IV (+ oral sequential therapy) is approved to treat Community Acquired Pneumonia (CAP), and Complicated Skin and Skin Structure Infections (cSSSI). Avelox® Oral is approved to treat Community Acquired Pneumonia (CAP) – except severe cases, Acute.

Bacterial Sinusitis (ABS) where adequately diagnosed, and Acute Exacerbations of Chronic Bronchitis (AECB).

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