Experts attending the 5^th International Moxifloxacin Symposium, heard how the rapid action and fast symptom relief offered by Aveloxâ (moxifloxacin), Bayer's new respiratory fluoroquinolone, will have an important role in reducing the enormous burden that community-acquired respiratory tract infections continue to place on patients and healthcare resources worldwide.

PARIS, FRANCE, November 17, 2001  -  Experts attending the 5^th International Moxifloxacin Symposium, heard how the rapid action and fast symptom relief offered by Aveloxâ (moxifloxacin), Bayer's new respiratory fluoroquinolone, will have an important role in reducing the enormous burden that community-acquired respiratory tract infections continue to place on patients and healthcare resources worldwide. The meeting heard how acute exacerbation of chronic bronchitis (AECB) alone affects 15 million people in the USA and over 20 million across Europe, and agreed that there's a real need to get patients back to normal as quickly as possible in order to reduce the escalating costs to society as well as the individual burden of lower respiratory tract infections.

Commenting on the situation, Professor Paul Léophonte, Professor of Pneumology at Paul Sabatier University, Toulouse, France, said, "We live in a world where patients have increasingly busy lives and are under greater pressure to return to work as fast as possible. They demand antibiotics that will relieve symptoms quickly, are convenient and well-tolerated - hence the trend towards shorter courses of drugs. The primary care physician, therefore, needs a thorough understanding of the available respiratory antimicrobials so that his choice will achieve a fast, positive, clinical response so that the patient is minimally inconvenienced by their infection", he concluded. Presenting data on the clinical effectiveness of moxifloxacin, Dr Marc Miravitlles, Co-ordinator of Clinical and Basic Research, Department of Pneumology, Hospital Vall d'Hebron, Barcelona, Spain, explained that this therapy has been assessed in a number of regulatory clinical trials and several 'real-world' studies in a primary care setting.

The latter were undertaken in Germany, Spain, and the USA with over 30,000 patients examined. The studies used patient questionnaires which highlighted the impact of the exacerbation on the patients' physical and mental health, as well as on their overall ability to perform normal duties and activities.
Results from these and earlier Phase IIIb clinical trials consistently showed that around two-thirds of patients reported feeling better by day three of treatment. These results are supported by the IMPAC study which found that moxifloxacin, in 441 patients, achieved faster symptom relief (from cough, shortness of breath and recovery from fever), and that patients were likely to return to work sooner. Moreover patients under moxifloxacin reported significantly less days of symptoms in AECB (6 days vs 5 days, p=0.02). Discussing the impact of sinustis, Dr Gavin Corcoran, Medical Research - anti-infectives, Bayer Corporation, explained, "As with AECB, acute bacterial sinusitis (ABS) is not only associated with a reduced quality of life for patients, but also contributes significant direct costs to the health care system resulting from second prescriptions for the same indication and health resource utilization."

He went on to present results of a study in which patients with ABS received treatment for 10 days with either: moxifloxacin 400 mg once daily, levofloxacin 500 mg once daily, or amoxicillin clavulanate 875/125 mg BID. The effect of each therapy on 'practice time use' was measured by the rate of second prescriptions (for sinusitis or treatment of medication side effects) during therapy, and for 14-days after treatment. The study also evaluated the rate of symptom relief at day three of antibiotic therapy.

Commenting on the results of this study, Dr Corcoran said, "The consistent, favourable patterns exhibited by moxifloxacin suggest significant benefits to healthcare providers, physicians and patients in terms of cost savings and overall satisfaction." Discussing the alarming rise in clinical failures, and the need to preserve the efficacy of an antimicrobial class, Dr Karl Weiss, Clinical Assistant Professor, Faculty of Medicine, University of Montreal, Canada, explained that during the last decade there has been an unexpectedly rapid evolution of antimicrobial resistance in the respiratory pathogens for community - and hospital-acquired pneumonia. "In order to choose the optimal therapy for patients, it is essential that physicians are aware of the prevalence and mechanisms of resistance, and their implications on the effectiveness of the various antimicrobials," he concluded.

Concluding the session, Professor Lionel Mandell, Chief Division of Infectious Diseases, McMaster University, Canada, gave an update on the safety profile of moxifloxacin. He said, "Moxifloxacin was designed to provide optimal pharmacodynamics, lower resistance potential and rapid efficacy with a low side effect profile. Typical class effects have been seen with moxifloxacin but at lower rates than comparator agents, and most of these events have been mild in nature and transient. With over 8 million patient uses, no major adverse events have been observed. Moxifloxacin has proven to be a safe and efficacious antimicrobial agent for the treatment of RTIs.

Moxifloxacin has been submitted for approval in 85 countries and has been launched in 66. Please see enclosed backgrounder which lists the countries where moxifloxacin (Avelox^®) is now available.

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