Results of the TOwards a Revolution in COPD Health (TORCH) study, the largest of its kind, have been published in the New England Journal of Medicine and represent a landmark in COPD, a disease which kills more people each year than breast cancer and lung cancer combined.
The results show important benefits of Seretide in the treatment of patients with COPD. The three-year study was designed to investigate reductions in death from any cause as the primary endpoint and also measured improvements in exacerbations (or worsening of symptoms) and quality of life as key secondary findings. The results from TORCH have been submitted to the regulatory authorities for consideration for inclusion into Seretide prescribing information.
In this study Seretide Diskus (50/500µg) treatment was associated with a 17.5% reduction in the risk of dying from any cause over three years (p=0.052) compared to placebo. This did not meet the predetermined level of statistical significance ofp=0.050. Seretide, when compared with placebo, also showed a 25% (p<0.001) reduction in the rate of exacerbations, which are a worsening of the patient's condition often causing increased difficulty in breathing. Exacerbations are a major cause of hospitalisation and have significant physical and psychological effects on patients, many of whom never fully recover from the impact.
Those treated with Seretide also showed an improvement in health related quality of life and FEV1, an established measure of lung function in patients with COPD, vs placebo over the three years of the study (p<0.001). While typically the health status of patients with COPD declines over time, patients receiving Seretide showed an improvement and their health status at the end of the three years remained above the baseline that they started from at the beginning of the study. For patients with COPD quality of life is severely affected, patients frequently experience anxiety, hopelessness and depression. In addition fatigue, commonly aggravated by sleep disturbances, and breathlessness, can not only severely limit physical activity, but in turn can also impact on a patient's economic and social roles. Up to 75% of patients with COPD report difficulty in the simplest of everyday activities, such as being out of breath after walking upstairs.
Commenting on the results, lead investigator Professor Peter Calverley said: "We are very proud of undertaking such an ambitious study. This is the first time a study has been carried out to investigate whether a medicine can have an impact on both survival and improvements in quality of life in patients with COPD. The steering committee for TORCH believes that these results are clinically important and have progressed our understanding of this disabling and potentially fatal disease, so that we can make informed choices in the treatment and management of our patients."
There was an increased risk of pneumonia seen as adverse events or serious adverse events in the inhaled corticosteroid containing arms of the TORCH study. The number of deaths while on treatment which were attributable to pneumonias, as adjudicated by the Clinical Endpoints Committee, was in the placebo group, in the salmeterol group, in the fluticasone propionate group, and in the Seretide group. Treatment with Seretide did not appear to be associated with an increased risk of COPD patients dying from pneumonia. There were no increases in bone or eye disorders in patients treated with Seretide compared with placebo.
Current guidelines state that in addition to relieving symptoms, preventing exacerbations and improving health-related quality of life, reducing mortality is a goal of COPD treatment. TORCH is the first study to investigate whether medication can affect survival in patients with COPD; to date smoking cessation, home oxygen treatment and lung volume reduction surgery are the only therapies shown to improve survival in patients with COPD.
Darrell Baker, head of the Respiratory Medicines Development Centre for GSK, said: "We are delighted with the results of this landmark study. The results have been submitted to regulatory authorities world-wide for consideration for inclusion into Seretide prescribing information."
The TORCH study was sponsored by GlaxoSmithKline.