New Study Compares Tiotropium (SPIRIVA^®) To Salmeterol In Treating Chronic Obstructive Pulmonary Disease
Tiotropium (SPIRIVA^®) patients had greater improvements in key measures, data show

BERLIN, GERMANY, September 24, 2001 - Tiotropium (SPIRIVA^®) was shown to be effective in treating patients with chronic obstructive pulmonary disease (COPD) and superior to the long-acting beta agonist salmeterol in several key measurements, according to data from a long-term clinical trial presented today at the annual meeting of the European Respiratory Society.

A six-month study involving 623 COPD patients showed that patients receiving tiotropium, a once-daily inhaled anticholinergic, had significantly improved lung-function measurements compared to patients receiving either placebo or salmeterol. Further, patients receiving tiotropium showed significant improvements in breathlessness and health-related quality of life versus placebo.

According to the data, patients who received either tiotropium or salmeterol showed statistically significant improvement in pre- and post-dose FEV1, the volume of air measured during forced exhalation, versus patients who took placebo. Tiotropium was shown to be significantly superior to salmeterol in lung function, as measured by FEV1, during the course of the study. There was no evidence of a loss of effectiveness of tiotropium during the course of the study.

Shortness of breath, known as dyspnea, represents the most disabling respiratory symptom for patients with COPD. In the study, patients receiving tiotropium reported a statistically significant improvement in shortness of breath versus patients who received placebo. There was no significant improvement in shortness of breath in patients treated with salmeterol versus placebo.

At the end of the study, tiotropium patients also reported statistically significant improvements in health-related quality of life as measured by the St. George's Respiratory Questionnaire, versus patients who took placebo. Using the same measure, the effects of salmeterol were not significantly different from placebo.

In this study the most common side effect associated with tiotropium was dry mouth. The proportion of patients who reported side effects was similar in all three treatment groups. However, the number of patients who withdrew from the study due to side effects was lower in the tiotropium group than in either the salmeterol group or the placebo group.

"These data show that we were able to provide COPD patients in this trial with positive and sustained therapeutic benefit," says Dr James Donohue, Professor of Medicine at the University of North Carolina in Chapel Hill.

Just found this, so thought id post it, as a few on it.   I would be pleased if anyone else on it would let us know how you get on with it.

Floppy   xxxx

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From: <NOBR>FloppyAutum2</NOBR> Sent: 28/02/2004 18:54 Spiriva, a novel anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva works through targeting of the primary reversible component of COPD—constriction of the airways. Spiriva helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. According to treatment guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), long-acting bronchodilators such as Spiriva are the preferred treatment option for COPD maintenance therapy. “Spiriva provides significant improvements in key measures of lung function and represents a major advance in the treatment of all stages of COPD,�?said Dennis E. Doherty, MD, chairman of the National Lung Health Education Program and professor of medicine and chief of the Division of Pulmonary and Critical Care Medicine at the University of Kentucky Medical Center. “Spiriva will become a first-line maintenance treatment for patients with mild to severe COPD. Patients may be able to control their symptoms for a full 24 hours with scheduled once-a-day use of Spiriva, allowing them to breathe easier, reduce their reliance on rescue medications and help them achieve a more normal lifestyle.�? In clinical trials, Spiriva demonstrated significant bronchodilation that was sustained over the duration of the studies. In trials, Spiriva demonstrated significant improvements in lung function over Atrovent® (ipratropium bromide), a current first line therapy for COPD, which were maintained over one year. In addition, in one-year, placebo-controlled studies, patients treated with Spiriva required fewer doses of rescue medications. Clinical studies both ongoing and completed include more than 9,400 patients. Spiriva was generally well tolerated. The most common adverse reaction patients reported in Spiriva clinical trials was dry mouth, which was usually mild and often resolved during treatment. Floppy   xxxxx