​CHEST: New Sub-Analyses Show Improvement in COPD Patient Outcomes with Spiolto® Respimat®

  • Studies show significant improvement with Spiolto® Respimat® in lung function across a range of age groups of patients* with COPD studied compared to tiotropium, olodaterol and placebo1
  • Additionally, night-time rescue medication use and shortness of breath has been reduced with Spiolto® Respimat®2,3

Ingelheim 28 October, 2015 — Boehringer Ingelheim today announced the presentation of several new post-hoc analyses from the TONADO® 1&2 and OTEMTO® 1&2 studies at the American College of CHEST Physicians Annual Meeting in Montreal. One analysis showed significant lung function improvement, as measured by FEV1 AUC0–3, with once daily Spiolto® Respimat® in COPD patients*across a range of age groups, including those over 65 years of age.1 In addition, a second analysis indicated that Spiolto® Respimat® reduces the frequency of night-time rescue medication use, as measured by puffs needed per night2 and these reductions were sustained for up to 52 weeks. In a third analysis the improvement of dyspnea (or shortness of breath), as measured by the Transition Dyspnea Index (TDI), was shown in COPD patients, compared to tiotropium, olodaterol and placebo.3

From early in the course of COPD, decreasing lung function makes it more and more difficult for patients to breathe. When many patients are first diagnosed their condition is already declining rapidly. To cope with feeling breathless, patients reduce their activity and change their lifestyles. Once symptoms start to prevent normal daily activities there is a downward spiral of reduced physical activity leading to worsening symptoms, further dyspnea and even further sedentary behavior.4 This in turn results in a large physical and emotional impact on people living with the disease.5

Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim
Dr William Mezzanotte,
Vice President and
Head of Respiratory
Medicine at
Boehringer Ingelheim

“The post-hoc data presented at the CHEST meeting demonstrate that Spiolto®Respimat® may provide improvement across several important clinical outcomes. These results further support the evidence of the benefit of using Spiolto® Respimat® in patients requiring COPD maintenance treatment. Providing optimal treatment right from the start of maintenance therapy can give patients the best chance of managing their symptoms, keeping active and limiting their need for rescue medication ”, said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim.

The most common adverse events in the TONADO® 1&2 and OTEMTO® 1&2 studies were nasopharyngitis (common cold), cough and back pain.

For more information see US press release: http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2015/10-27-2015-new-sub-analyses-presented-stiolto-respimat-across-range-patient-reported-outcomes-measures.html

For further information visit: http://www.boehringer-ingelheim.com/respiratory/respiratory-overview

OTEMTO®Respiratory Medicine publication: http://www.resmedjournal.com/article/S0954-6111(15)30034-2/abstract

About Spiolto® Respimat®
To date, Spiolto® Respimat® has been approved in more than 20 EU/EEA countries, the US, Canada and Australia for use in the treatment of patients with COPD.

Spiolto® Respimat® is built on tiotropium, the active ingredient in Spiriva® - the world’s most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities.6 It is enhanced by olodaterol†, a unique and effective long-acting beta2-agonist with a fast onset of action,7 specifically designed to complement the efficacy of Spiriva®. Spiolto® is delivered by Respimat®, which actively‡ delivers a unique mist, meaning the patient just needs to take a slow deep breath.8-14

About COPD
COPD is a chronic, progressive, treatable but incurable lung disease that affects 210 million people worldwide.15 It is a growing world health priority and is predicted to become the 3rd leading cause of death by 2030.16

For people with COPD, decreasing lung function causes breathlessness and stops them from being active. This can lead to a downward spiral of worsening symptoms and even further inactivity,4 contributing to an increased risk of disability and death.17

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

Footnotes

* Included were patients requiring maintenance treatment

† Marketed as Striverdi® Respimat®

‡ Respimat® delivers a metered dose of medication in a mist at the push of a button requiring just a slow deep breath from a patient

Referências

  1. Ferguson, G. Lung Function Response with Tiotropium + Olodaterol Maintenance Treatment in Patients with COPD in the TONADO and OTEMTO Studies: a Subgroup Analysis by Age. CHEST; October 24-28, 2015; Montreal.
  2. Abrahams, R. Effect of Tiotropium + Olodaterol on the Use of Night-Time Rescue Medication in Patients with COPD: Results from Four Randomized, Double-Blind Studies. CHEST; October 24-28, 2015; Montreal.
  3. Ferguson, G. Tiotropium + Olodaterol Provides Improvements in SGRQ and Dyspnea Compared with Monotherapy Components in Patients with COPD: Results from Four Randomized, Double-Blind Studies. CHEST; October 24-28, 2015; Montreal
  4. Reardon JZ, Lareau SC, ZuWallack R. Functional status and quality of life in chronic obstructive pulmonary disease. Am J Med 2006; 119: 32-37.
  5. Confronting COPD in America: Executive Summary. New York, NY: Schulman, Ronca, and Bucuvalas Inc; 2001:1-20.
  6. BI data on file.
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  8. Newman SP, Brown J, Steed KP, Reader SJ, Kladders H. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat® with conventional metered-dose inhalers with and without spacer devices. Chest 1998; 113:957-63.
  9. Pitcairn G, Reader S, Pavia D, Newman S. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med 2005; 18(3):264-72.
  10. Peterson JB, Prisk GK, Darquenne C. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008; 21(2):159–68.
  11. Dalby R, Spallek M, Voshaar T. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9.
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  13. Dalby RN, Eicher J, Zierenberg B. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-55.
  14. Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006;1(3): 251–59.
  15. WHO. Global Alliance Against Chronic Respiratory Diseases. Chronic Respiratory Diseases. http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf[Last accessed June 2015]
  16. WHO. Chronic respiratory diseases, Burden of COPD. http://www.who.int/respiratory/copd/burden/en/index.html
  17. Casaburi R. Activity promotion: a paradigm shift for chronic obstructive pulmonary disease therapeutics. Am Thorac Soc 2011; 8(4):334-37.