New Large-Scale Trial Results Show Stiolto® Respimat® Prevents COPD Exacerbations Better Than Spiriva® Respimat®
RIDGEFIELD, Conn., March 29, 2018 /PRNewswire/ -- Boehringer Ingelheim announced today that data from the DYNAGITO trial, a 52-week study involving more than 7,800 people across a broad range of COPD patients, comparing Stiolto Respimat (tiotropium bromide and olodaterol), a dual bronchodilator, and Spiriva Respimat (tiotropium bromide) in the reduction of COPD exacerbations, were published today in The Lancet Respiratory Medicine.
tiotropium bromide olodaterol
"Exacerbations can have a significant negative impact on people with COPD because they can cause permanent lung damage and possibly lead to lengthy hospitalizations or even death. Therefore, COPD treatment strategies should include steps to reduce the risk of exacerbations," said Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of Texas Health Science Center at San Antonio, who served as an investigator and co-author for DYNAGITO. "Because exacerbations can cause COPD to progress more quickly, studies such as DYNAGITO are important to understand how medicines can help prevent exacerbations from affecting patients."
A COPD exacerbation, or a flare-up, is a sudden worsening of symptoms, such as increased breathlessness, cough, mucus production and extreme fatigue. In addition to the detrimental effects on patients' health, COPD exacerbations have a significant burden on the healthcare system as a whole.
The DYNAGITO study results show that treatment with Stiolto Respimat resulted in a 7 percent lower rate of moderate-to-severe COPD exacerbations compared with Spiriva Respimat alone (p=0.0498), not reaching the targeted significance level (p=0.01) as pre-defined in the study. 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 Anzueto.
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.
About the Respimat InhalerThe RESPIMAT inhaler was designed to get the medicine deep into patients' lungs as a slow-moving mist. Unlike dry powder inhalers that require a deep breath to inhale the medicine, the RESPIMAT inhaler operates independent of inspiratory effort, helping patients effectively breathe the medicine into their lungs while minimizing inhalation effort.
As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).
Boehringer Ingelheim's RESPIMAT family of products includes five FDA-approved medicines for COPD and asthma.
Indication for STIOLTO RESPIMAT
STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.About Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.SOURCE Boehringer Ingelheim Pharmaceuticalshttps://www.prnewswire.com/https://www.prnewswire.com/