To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Ariflo Improves Pulmonary Function In COPD Patients URL: http://www.pslgroup.com/dg/13792E.htm Doctor's Guide October 12, 1999
MADRID, SPAIN -- October 12, 1999 -- Results of a new study(1) demonstrate that SmithKline Beecham's investigational compound Ariflo® (SB 207499)(2) improved lung function, symptoms and quality of life measurements among people suffering from the serious and potentially fatal respiratory disorder known as chronic obstructive pulmonary disease (COPD). Findings from this Phase II study, presented today at the annual meeting of the European Respiratory Society* (ERS) in Madrid, Spain, suggest Ariflo may represent a major therapeutic advance against COPD.
COPD is a progressive disorder characterized by airflow obstruction.(3) The term COPD is used to define a group of diseases that cause airflow blockage and include chronic bronchitis, emphysema or a combination of these disorders.
"The results of this study are very encouraging," said Professor Peter Barnes of the Royal Brompton National Heart & Lung Institute, London, UK. "COPD is a devastating lung disease for which we can currently do little but provide symptomatic relief. With Ariflo, we have a compound, which potentially targets not only the symptoms of the disease but also the multiple underlying components of airway obstruction and inflammation. This is a highly promising development," he added.
PDE4 Inhibition: A New Therapeutic Approach
Ariflo is a member of a novel class of agents known as selective phosphodiesterase 4 (PDE4) inhibitors. PDE4 inhibitors have the potential to reduce lung inflammation in COPD. PDE4 inhibitors increase levels of the naturally occurring substance found in cells called cyclic adenosine monophosphate (cAMP), a key modulator of inflammatory cell activation.
Preclinical data indicate that PDE4 inhibition with Ariflo may reduce:
- Bronchoconstriction
- Inflammation and the resulting destruction of the airways
- Symptoms such as cough and breathlessness
Study Results Promising
A total of 424 patients with relative fixed lung obstruction and a poor response to a bronchodilator participated in the double-blind, placebo-controlled, randomized, dose-ranging study which measured pulmonary function and quality of life using accepted assessment scales. Patients were randomized in a double-blind method to six weeks' treatment with placebo or Ariflo at doses up to 15 mg twice daily.
The results showed that, at a dose of 15 mg twice daily, Ariflo significantly improved lung function as measured by Forced Expiratory Volume (FEV1), an important measure of airflow in the lungs. At the end of the study, patients treated with 15 mg of Ariflo twice daily showed, on average, a 10 percent improvement (130 mL) in FEV1 from baseline and experienced an improvement in breathlessness. Additionally, more than a third of these patients (38 percent) used bronchodilators less than usual.
The study also demonstrated an improvement in the St. George's Respiratory Questionnaire (SGRQ) -- a disease specific tool validated to measure quality of life in COPD patients.
In this study, Ariflo was generally well tolerated with the most common treatment-related adverse events being nausea, diarrhea and abdominal pain.
COPD: Fifth Leading Cause of Death Worldwide
It is estimated that worldwide as many as 600 million people have COPD,(4) including approximately 25 percent of Americans over age 40.(5) In 1996, COPD was the fifth leading cause of death worldwide(5) and current trends suggest it will become the third leading cause of death by the year 2020.(6)
The primary trigger for COPD is cigarette smoking. The vast majority of patients with COPD are current or former smokers, and it is estimated that 80 to 90 percent of all COPD cases are caused by smoking.(7) The likelihood of dying as a result of COPD is 10 times higher for a smoker than for a non-smoker,(8) which reinforces the importance of smoking cessation. Other potential risk factors for developing COPD include childhood asthma, occupational exposure and air pollution.
The European Respiratory Society is the biggest respiratory organization in Europe with more than 5,000 members from 81 countries. Its members consist of scientists, researchers and other respiratory health professionals dedicated to promoting respiratory medicine in Europe.
References
(1) Compton CH, Gubb J, Cedar E, Bakst A, Nieman RB, Amit O, Ayres J, Brambilla C. Ariflo® (SB 207499), an oral, selective PDE4 inhibitor improves health status in patients with COPD. Presented, European Respiratory Society Meeting, October 12, 1999.
(2) Trademark SmithKline Beecham Pharmaceuticals plc, Harlow, UK.
(3) Petty T. The worldwide epidemiology of chronic obstructive pulmonary disease. Curr Opin Pulm Med 1998;2:84-89.
(4) World Health Organisation. The world health report 1997.
(5) World Health Organisation. The world health report 1997.
(6) Murray, CJL, Lopez, AD. The Global Burden of Disease and Injury,1.
(7) American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1995;152:S77-S120.
(8) American Lung Association. Chronic Obstructive Pulmonary Disease (COPD). American Lung Association Fact Sheet, September, 1998. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.