Avelox® Monotherapy Shows Strong Performance In Treating Hospitalized Pneumonia Patients

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 May 2008 - 0:00 PDT

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A recently published study in Clinical Infectious Diseases shows that Avelox® (moxifloxacin HCl) monotherapy is as powerful as a high dose combination regimen of ceftriaxon plus levofloxacin in the treatment of hospitalised patients with community-acquired pneumonia (CAP). A total of 569 patients at 69 centres in 17 countries from Southern and Northern Europe, Latin America and South Africa were treated in the MOTIV(1) trial (MOxifloxacin Treatment IV). The prospective, multi-centre, randomised, double-blind, non-inferiority study, was sponsored by Bayer Schering Pharma and assessed by three independent committees of international experts.

"The results of MOTIV reinforce that moxifloxacin is an effective and well tolerated therapy for CAP patients in the hospital setting. Moreover, the once daily monotherapy provides a very convenient treatment option for the patient as well as for the healthcare professional," said Dr. Antoni Torres, Professor of Pulmonology at the University of Barcelona (Spain) and one of the lead investigators of MOTIV. "It was very important to see comparable clinical cure rates with moxifloxacin monotherapy when tested against a highly potent combined comparator regimen, and this study further demonstrates the efficacy of moxifloxacin in treating CAP."

CAP is one of the major causes of morbidity and mortality in developed countries; in fact mortality rates ranging from 4% to 14% have been reported for patients requiring hospitalization.(2, 3, 4) In up to 50% of all hospitalized CAP patients, the causative pathogen is Streptococcus pneumoniae.(5) Moxifloxacin, a member of the fluoroquinolone class of antibiotics (PEG-group 4), has excellent activity against S. pneumoniae, along with the additional advantage of a once daily dosing.(6, 7) Although a number of studies have confirmed the efficacy of moxifloxacin in the treatment of mild to moderate CAP,(8, 9, 10, 11) only limited data on its use in patients hospitalised with more serious CAP are available. The MOTIV study was conducted to fill this information gap.

"Pneumonia is of particular concern for the elderly and for people who suffer from chronic illnesses or who have an impaired immune system," explained Dr. Martin Springsklee, Vice President, Global Medical Affairs, Bayer Schering Pharma. "With Avelox, we offer an effective and reliable treatment option, so that patients may recover as fast as possible from this debilitating disease."

About MOTIV

The per protocol (PP) population of MOTIV consisted of 569 patients, 291 in the moxifloxacin and 278 in the comparator arm. Patients in the moxifloxacin arm received sequential intravenous (IV)/oral moxifloxacin 400mg once daily. Patients in the comparator arm received IV ceftriaxon 2g twice daily plus IV levofloxacin 500mg twice per day and later be switched to oral levofloxacin 500mg twice daily. Both groups were treated for a total of 7-14 days. At the test-of-cure assessment, there was no significant difference in the clinical cure rates obtained with the two treatments (86.9% moxifloxacin group vs. 89.9% comparator group; 95% CI: -8.1-2.2%) irrespective of the severity of pneumonia. Both regimens were well tolerated and there were no significant differences in the incidence of adverse effects or mortality between both treatment arms.

About Avelox®

World-wide Avelox is currently approved in 109 countries for the oral formulation and 90 countries for the intravenous (IV) formulation. Avelox IV is approved to treat Community Acquired Pneumonia (CAP), complicated Skin and Skin Structure Infections (cSSSI) and complicated Intra Abdominal Infections (cIAI). Avelox tablets are approved to treat Community Acquired Pneumonia (CAP) except severe cases, Acute Bacterial Sinusitis (ABS) where adequately diagnosed, and Acute Exacerbations of Chronic Bronchitis (AECB). Licensed indication(s) can differ from country to country. For Avelox prescribing information and indicated organisms visit http://www.avelox.com.

About Bayer

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Forward Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

(1) Torres A et al.: Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia. The MOTIV study: a randomised clinical trial. Clin Infect Dis 2008

(2) Jokinen C, Heiskanen L, Juvonen H, Kallinen S, Karkola K, Korppi M et al.: Incidence of community-acquired pneumonia in the population of Four Municipalities in Eastern Finland. Am J Epidemiology 1993, 997-88

(3) Lim WS, Macfarlane JT, Boswell TC, Harrison TC, Rose D, Leinonen MC et al.: SCAPA: Study of Community Acquired Pneumonia Aetiology in adults admitted to hospital: implications for management guidelines. Thorax 2001; 56: 296-301

(4) Laurichesse H, Sotto A, Bonnet E, Abraham B, Neau D, Badiaga S, Gaillat J, Fabbro-Peray P; Infectio-Sud Study Group: Pre- and in-hospital management of community-acquired pneumonia in southern France, 1998-1999, Eur J Clin Microbil Infect Dis 2001; 20:770.78

(5) Marrie TJ: Pneumococcal pneumonia: epidemiology and clinical features. Semin Respir Infect 1999; 14: 227-36

(6) Zhanel GG, et al. A review of new fluoroquinolones: focus on their use in respiratory tract infections. Treat Respir Med 2006; 5: 437-465

(7) Blondeau JM. A review of the comparative in-vitro activities of 12 antimicrobial agents, with a focus on five new 'respiratory quinolones. J Antimicrob Chemother 1999; 43(Suppl B): 1-11.

(8) i Finch R, Schurmann D, Collins O, et al.: A randomized controlled trial of sequential intravenous (i.v.) and oral moxifloxacin compared with sequential i.v. and oral co-amoxiclav with or without clarithromycin in patients with community acquired pneumonia requiring initial parenteral treatment. Antimicrob Agents Chemother 2002; 46:1746-1754

(9) Hoeffken G, Meyer HP, Winter J, Verhoef L; CAP Study Group: The efficacy and safety of two oral moxifloxacin regimens compared to oral clarithromycin in the treatement of community-acquired pneumonia. Respir Med 2001; 95:553-64

(10) Torres A, Muir JF, Corris P, et al.: Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia. Eur Respir J 2003; 21:135-43

(11) Welte T, Petermann W, Schuermann D, Bauer TT, Reimnitz P; MOXIRAPID Study Group. Treatment with sequential intravenous or oral moxifloxacin was associated with faster clinical improvement than was standard therapy in hospitalised patients with community-acquired pneumonia who received initial parenteral therapy. The MOXIRAPID Study Group. Clin Infect Dis 2005; 41:1697-705