Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease Export

@article{citeulike:2973215, abstract = {Background Long-acting beta-agonists and inhaled corticosteroids are used to treat chronic obstructive pulmonary disease (COPD), but their effect on survival is unknown. Methods We conducted a randomized, double-blind trial comparing salmeterol at a dose of 50 {micro}g plus fluticasone propionate at a dose of 500 {micro}g twice daily (combination regimen), administered with a single inhaler, with placebo, salmeterol alone, or fluticasone propionate alone for a period of 3 years. The primary outcome was death from any cause for the comparison between the combination regimen and placebo; the frequency of exacerbations, health status, and spirometric values were also assessed. Results Of 6112 patients in the efficacy population, 875 died within 3 years after the start of the study treatment. All-cause mortality rates were 12.6\% in the combination-therapy group, 15.2\% in the placebo group, 13.5\% in the salmeterol group, and 16.0\% in the fluticasone group. The hazard ratio for death in the combination-therapy group, as compared with the placebo group, was 0.825 (95\% confidence interval [CI], 0.681 to 1.002; P=0.052, adjusted for the interim analyses), corresponding to a difference of 2.6 percentage points or a reduction in the risk of death of 17.5\%. The mortality rate for salmeterol alone or fluticasone propionate alone did not differ significantly from that for placebo. As compared with placebo, the combination regimen reduced the annual rate of exacerbations from 1.13 to 0.85 and improved health status and spirometric values (P<0.001 for all comparisons with placebo). There was no difference in the incidence of ocular or bone side effects. The probability of having pneumonia reported as an adverse event was higher among patients receiving medications containing fluticasone propionate (19.6\% in the combination-therapy group and 18.3\% in the fluticasone group) than in the placebo group (12.3\%, P<0.001 for comparisons between these treatments and placebo). Conclusions The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients. (ClinicalTrials.gov number, NCT00268216 .) 10.1056/NEJMoa063070}, author = {Calverley, Peter M. and Anderson, Julie A. and Celli, Bartolome and Ferguson, Gary T. and Jenkins, Christine and Jones, Paul W. and Yates, Julie C. and Vestbo, Jorgen and Investigators, The T.}, citeulike-article-id = {2973215}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa063070}, citeulike-linkout-1 = {http://content.nejm.org/cgi/content/abstract/356/8/775}, citeulike-linkout-2 = {http://view.ncbi.nlm.nih.gov/pubmed/17314337}, citeulike-linkout-3 = {http://www.hubmed.org/display.cgi?uids=17314337}, day = {22}, doi = {10.1056/NEJMoa063070}, journal = {N Engl J Med}, keywords = {aecopd, causeofdeath, copd, death, ics, laba, rct, torch}, month = {February}, number = {8}, pages = {775--789}, posted-at = {2009-06-02 05:11:36}, priority = {2}, title = {Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease}, url = {http://dx.doi.org/10.1056/NEJMoa063070}, volume = {356}, year = {2007} }

TY - JOUR ID - citeulike:2973215 L3 - citeulike-article-id:2973215 N2 - Background Long-acting beta-agonists and inhaled corticosteroids are used to treat chronic obstructive pulmonary disease (COPD), but their effect on survival is unknown. Methods We conducted a randomized, double-blind trial comparing salmeterol at a dose of 50 {micro}g plus fluticasone propionate at a dose of 500 {micro}g twice daily (combination regimen), administered with a single inhaler, with placebo, salmeterol alone, or fluticasone propionate alone for a period of 3 years. The primary outcome was death from any cause for the comparison between the combination regimen and placebo; the frequency of exacerbations, health status, and spirometric values were also assessed. Results Of 6112 patients in the efficacy population, 875 died within 3 years after the start of the study treatment. All-cause mortality rates were 12.6% in the combination-therapy group, 15.2% in the placebo group, 13.5% in the salmeterol group, and 16.0% in the fluticasone group. The hazard ratio for death in the combination-therapy group, as compared with the placebo group, was 0.825 (95% confidence interval [CI], 0.681 to 1.002; P=0.052, adjusted for the interim analyses), corresponding to a difference of 2.6 percentage points or a reduction in the risk of death of 17.5%. The mortality rate for salmeterol alone or fluticasone propionate alone did not differ significantly from that for placebo. As compared with placebo, the combination regimen reduced the annual rate of exacerbations from 1.13 to 0.85 and improved health status and spirometric values (P<0.001 for all comparisons with placebo). There was no difference in the incidence of ocular or bone side effects. The probability of having pneumonia reported as an adverse event was higher among patients receiving medications containing fluticasone propionate (19.6% in the combination-therapy group and 18.3% in the fluticasone group) than in the placebo group (12.3%, P<0.001 for comparisons between these treatments and placebo). Conclusions The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients. (ClinicalTrials.gov number, NCT00268216 .) 10.1056/NEJMoa063070 IS - 8 JF - N Engl J Med EP - 789 TI - Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease VL - 356 SP - 775 KW - aecopd KW - causeofdeath KW - copd KW - death KW - ics KW - laba KW - rct KW - torch AU - Calverley, Peter AU - Anderson, Julie AU - Celli, Bartolome AU - Ferguson, Gary AU - Jenkins, Christine AU - Jones, Paul AU - Yates, Julie AU - Vestbo, Jorgen AU - Investigators, The PY - 2007/02/22/ UR - http://dx.doi.org/10.1056/NEJMoa063070 ER -