Final results from landmark DYNAGITO® trial published in The Lancet Respiratory Medicine

Boehringer Ingelheim 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.11 These 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

About COPD
COPD is a growing world health priority and the World Health Organization predicts it will become the third leading cause of death by 2030.12 It is a progressive disease that limits airflow in and out of the lungs, making it difficult for patients to breathe and limiting their involvement in daily activities, even from very early on in the disease.8,9,10 Long-term prognosis for patients following hospitalisation for COPD exacerbation is poor, with 50% of patients dying within five years.7

About DYNAGITO®
The 52-week DYNAGITO® study is the first to investigate, as a primary endpoint, whether the LAMA/LABA tiotropium/olodaterol offers reduction in the annualised rate of moderate and severe exacerbations beyond the LAMA tiotropium in patients with moderate to very severe COPD (FEV1 < 60%) with at least one moderate or severe exacerbation requiring treatment with systemic glucocorticoids and/or antibiotics or hospitalisation in the previous 12 months.1 The DYNAGITO® trial is part of the large-scale TOviTO® Phase III clinical trial programme involving over 16,000 patients, designed to investigate the efficacy and safety of tiotropium/olodaterol in COPD.1,2,3,4,5,13,14,15,16,17

About Spiolto® Respimat® (tiotropium/olodaterol)
Tiotropium/olodaterol is approved as once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. It is built on tiotropium, the active ingredient in Spiriva® and is enhanced by olodaterol (Striverdi®) which was specifically designed to complement the efficacy of tiotropium. Tiotropium/olodaterol provides significant improvements in lung function, COPD symptoms and quality of life over tiotropium – right from the initial stages when suitable patients need maintenance therapy.2,3,4,5,6
Tiotropium/olodaterol is administered via Respimat®, the only inhaler available that actively delivers a unique mist, meaning a person just needs minimal effort breathing in for the medication to go deep into the lungs.‡,18,19,20,21,22

About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com