It was the first large-scale trial to directly compare the two different treatment approaches. The researchers recruited 1,323 patients with severe COPD and randomized them to receive one of two treatments - either SFC or tiotropium - for two years. They analysed number and type of exacerbations, health status as measured by the St. George’s Respiratory Questionnaire (SGRQ), lung function (post-dose forced expiratory volume in one second) and study withdrawal rate. The study was double-blinded and double-dummy controlled, and all patients underwent identical intensification of treatment before beginning the trial to standardize their clinical conditions.
While exacerbation rates between the two treatment groups were statistically indistinguishable, there were differences in the treatment that the exacerbations required. Oral corticosteroids were used more often to treat the tiotropium group, whereas patients on SFC required antibiotics more frequently.
“This finding provides indirect evidence that these treatments affect apparently similar patients in different ways that affect clinical judgment,” explained Jadwiga Wedzicha, M.D., of the Royal Free & University College Medical School in London. “This difference warrants further study to determine the factors that affect therapeutic choice.” Most strikingly, mortality was significantly lower in the SFC group during the study period, even though the trial was not powered to detect such a difference. There was more than a 50 percent reduction in the risk of on-therapy all-cause death at any time during the study period for the SFC patients. Patients undergoing SFC treatment were also significantly less likely to withdraw from the trial than others.
MEDICA.de; Source: American Thoracic Society (ATS)