According to data from the DYNAGITO trial, a 52-week study involving more than 7,800 COPD patients, Stiolto Respimat (tiotropium bromide and olodaterol) was superior to Spiriva Respimat (tiotropium bromide) in reducing COPD exacerbations. The data was published today in The Lancet Respiratory Medicine and reported by Boehringer Ingelheim.
The DYNAGITO study results show that treatment with Stiolto Respimat resulted in a 7% lower rate of moderate-to-severe COPD exacerbations compared with Spiriva Respimat alone. The results did not reach the targeted significance level (p=0.01) as pre-defined in the study, however.
The study results also show Stiolto Respimat significantly reduced COPD symptoms and improved health-related quality of life, as measured by the COPD Assessment Test (CAT), compared to Spiriva Respimat.
“The findings from the DYNAGITO trial show that Stiolto Respimat provides a clinically important benefit compared to Spiriva Respimat, a well-established treatment approved by the FDA to reduce the risk of COPD exacerbations,” said Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of TexasHealth Science Center at San Antonio, who served as an investigator and co-author for DYNAGITO.
No new side effects or safety concerns were identified in the study, providing additional confirmation in a COPD population at risk for COPD exacerbations, that Stiolto Respimat has a similar safety profile to Spiriva Respimat.