Important new data from the analysis of combined data from the two pivotal Symbicort(R) studies, announced today at the 5th International Multidisciplinary Conference on Chronic Obstructive Pulmonary Disease (COPD5), reveals that budesonide added to formoterol (Symbicort(R)) and/or terbutaline significantly reduces mortality in severe COPD over one year, compared to the bronchodilators formoterol and/or terbutaline alone.
Today's results show fewer deaths in the Symbicort / budesonide group compared with the bronchodilator group (p=0.036), with an associated hazard ratio of 0.564 (p=0.039). This represents a 44% reduction in all-cause
mortality over one year for patients treated with Symbicort / budesonide(1).
"Previous findings have shown the beneficial effects of combination budesonide and formoterol, i.e. Symbicort, therapy in significantly reducing COPD exacerbations", explained Professor Peter Calverley, Aintree Chest
Centre, University of Liverpool. "Today's presentation further demonstrates the link between COPD exacerbations and an increased risk of mortality, reinforcing the importance of reducing these events, as indicated by COPD
The re-analysis comprised data from 1834 patients with severe COPD evenly distributed between the two treatment groups, i.e. budesonide added to bronchodilators compared to bronchodilators alone.
The survival benefits in this analysis also appear to corroborate the findings in the three year prospective TORCH (TOwards a Revolution in COPD health) study(2), presented at the American Thoracic Society Congress in 2006, which has reported a 17% reduction in mortality for fluticasone/salmeterol compared with placebo.
The retrospective pooled analysis also showed that health-related quality of life (HRQL) - as measured by the St. Georges Respiratory Questionnaire (SGRQ), an independently validated tool for measuring quality of life in COPD
- was the strongest predictor of mortality in COPD, over and above any other reported predictor (e.g. lung function, breathlessness, Body Mass Index and age), equating to better quality of life leading to lower risk of premature
death(3). Using the SGRQ, a change of four points is defined as clinically meaningful, equating to a patient being able to walk up a flight of stairs without stopping or to being able to sleep without disruption from coughing.
The data presented today suggests that SGRQ scores may have a role in identifying patients at increased risk of mortality over 1 year.
"Previous studies have demonstrated that budesonide/ formoterol is a very effective treatment in preventing COPD exacerbations, leading to clinically important improvements in health-related quality of life", explained Professor
Paul Jones, St George's Hospital Medical School, London "Today's data are important, suggesting as it does that a combination of budesonide and formoterol may provide a tangible survival benefit as well as improving the
patients quality of life".
The pooled-analysis, presented today at COPD5, is based upon the data from two 1-year prospective Symbicort studies in COPD (Calverley et al. (4) and Szafranski et al(5)), both published in the European Respiratory Journal in
"Randomised, controlled trials are the best way of determining whether therapy is effective in COPD. However, re-analysis of pooled data from comparable clinical trials, as we did in this case, can provide new and
potentially important clinical insights", Professor Calverley concluded.