INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced data from the landmark 52-week DYNAGITO® trial which show that in people with COPD (chronic obstructive pulmonary disease), Spiolto® Respimat® (tiotropium/olodaterol 5/5µg) lowers the rate of moderate-to-severe exacerbations compared with Spiriva® Respimat® (tiotropium). The pre-specified significance level of p<0.01 for the primary endpoint of DYNAGITO® was not met.1 Treatment with tiotropium/olodaterol resulted in a 7% lower rate of moderate-to-severe COPD exacerbations compared with tiotropium alone (p=0.0498).1 This study, involving more than 7,800 people with COPD over 1 year, was published today in The Lancet Respiratory Medicine.1
“The results of DYNAGITO® are of value, as they show that tiotropium/olodaterol can lower the rate of moderate-to-severe exacerbations in many patients compared to tiotropium – a tough comparator which has consistently demonstrated exacerbation risk reduction through long-term, real-world experience,” said study investigator Professor Peter M.A. Calverley, Professor of Pulmonary Medicine, University of Liverpool, UK. “These data support evidence-based expert recommendations that dual bronchodilator LAMA/LABA therapy has a central role in the management of people with COPD, in terms of symptom improvement and exacerbation risk reduction.”7
COPD is a progressive, yet treatable condition that significantly impacts patients’ lives, restricting their daily activities from early on in the disease.8,9,10 COPD exacerbations, or flare-ups, are sudden episodes of increased breathlessness, cough and mucus production that can last for several days or even weeks.11These episodes can be seriously disabling, resulting in a need for urgent medical care, including hospitalisation, and sometimes lead to death.11
Further DYNAGITO® data demonstrated that tiotropium/olodaterol was associated with fewer moderate-to-severe exacerbations that needed intervention with a systemic corticosteroid, with or without antibiotics, compared with tiotropium:1*
- A 20% lower rate of moderate-to-severe exacerbations that required treatment with a systemic corticosteroid (p=0.0068).1*
- A 9% lower rate of exacerbations where the use of both a systemic corticosteroid and antibiotics were needed (p=0.0447).1*
- No difference was observed in the rate of exacerbations that required treatment with antibiotics only (p=0.2062).1*
No new side effects or safety concerns were identified in the DYNAGITO® study.1 These data also show that tiotropium/olodaterol has a similar safety profile to tiotropium.1
Reducing symptoms and the future risk of exacerbations are key treatment goals for COPD.7 According to the international GOLD† 2018 Strategy recommendations, LAMA/LABA treatments such as tiotropium/olodaterol play a central role in the management of COPD and help to achieve these treatment goals.7
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For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/results-landmark-dynagito-trial
* The pre-specified significance level of p<0.01 for the primary endpoint of DYNAGITO® was not met
† Global Initiative for Chronic Obstructive Lung Disease
