To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ATS: COPD Patients Improve Quality of Life With Foradil (Formoterol Fumarate) URL: http://www.pslgroup.com/dg/1D0AEA.htm Doctor's Guide May 8, 2000
TORONTO, ON -- May 8, 2000 -- New data from phase III clinical trials presented today at the 96th American Thoracic Society meeting suggest that Foradil(R) (formoterol fumarate), Novartis' fast-onset, long-acting bronchodilator (beta2-agonist), may help patients with chronic obstructive pulmonary disease (COPD) enjoy a better quality of life. "When dealing with a chronic respiratory condition such as COPD, the treatment goal is to enhance the patient's quality of life,'' said Kenneth Chapman, MD, Professor of Medicine, University of Toronto, and Director of the Asthma Center and Pulmonary Rehabilitation Program, Toronto Western Hospital, University Health Network. "Compared to placebo, formoterol-treated patients suffered fewer exacerbations, were more active, and were less disabled by their condition, all areas that are critical to the quality of life of COPD patients.'' The first phase III study showed that inhaled formoterol dry powder (Foradil) can improve quality of life for COPD patients, while reducing the number of "bad days'' these patients experience. The extensive, 12-week, multicenter clinical trial examined lung function and quality of life in 780 patients with COPD and compared inhaled Foradil (12mcg or 24mcg twice daily) via the Aerolizer to inhaled ipratropium bromide (40mcg four times a day), and with placebo. Quality of life (which included scores for symptoms, activities and disease impacts) improved significantly in patients treated with Foradil (p being less that 0.01 for the two Foradil groups compared with placebo). For patients on ipratropium, this change was not statistically different compared to placebo. Patients logged their "bad days,'' defined as days with high symptom scores and/or a 20 percent fall from baseline in peak expiratory flow (PEF). Patients on Foradil had 10-14 percent fewer bad days compared with placebo and 8-11 percent fewer bad days compared with ipratropium (p being less than 0.01). The 2 percent difference between ipratropium and placebo was non-significant. During the study, patients receiving Foradil also experienced a significantly greater bronchodilator effect (AUC-FEV1), compared with ipratropium and placebo. Both treatments were well tolerated, noted the investigators. A second phase-III study of one year in 854 patients compared Foradil (12 or 24mcg given twice daily) with oral slow-release theophylline and placebo. The effect on lung function (AUC-FEV1) improved significantly with both Foradil doses compared with placebo. Theophylline was also significantly more effective than placebo, but the improvement was limited to those patients who were classed as "reversible'' (a bronchodilator effect of more than 15 percent after inhaling salbutamol 200mcg). With Foradil, the improvement was seen in all patients irrespective of reversibility. This may be valuable for the treatment of COPD, where patients tend to have poorly reversible airway obstruction. As in the 12-week trial comparing formoterol with ipratropium, there were no tolerability issues for formoterol during the theophylline trial. There were also fewer treatment-related adverse effects with formoterol (9 percent at 12 mcg b.i.d. and 8 percent at 24 mcg b.i.d.) than theophylline (32 percent). Foradil is already marketed for use in chronic bronchitis and emphysema, (commonly known as COPD), in all EU countries except France, Germany, Sweden and UK. A new drug application for Foradil as a treatment for COPD patients will be submitted to the US regulatory authorities later this year. It is administered by an easy-to-use, inhaler called the Aerolizer, with which patients can "hear, feel and see'' that they have correctly taken their medication. These features may be particularly beneficial for the elderly population of COPD patients. COPD is a common chronic lung disease and leading cause of mortality world-wide, with 2.25 million deaths a year (4.2 percent of total deaths). By 2025, the World Health Organization estimates that COPD will be the third leading cause of death globally. A major cause of COPD is cigarette smoking. Foradil is made by Novartis, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Novartis Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested more than CHF 4.2 billion in R&D. Headquartered in Basle, Switzerland, Novartis employs about 82,400 people and operates in more than 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. 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