WISDOM trial suggests only a minority of COPD patients benefit from the addition of an ICS on top of Spiriva®+LABA, and these are clearly identifiable4

Document ID: PC-MY-100462

01/03/2019

Author: Boehringer Ingelheim


Long term ICS use is associated with systemic and local side effects.5-8 Data from WISDOM suggests that only a minority of patients will benefit from the addition of an ICS to LAMA/LABA. These patients have 3 characteristics - Severe/very severe airflow limitation, a history of ≥2 exacerbations per year & blood eosinophil ≥300 cells per μL.9

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References

1. Pitcairn G et al. J Aerosol Med 2005;3:264-272.
2. Anderson A. Int J Chron Obstruct Pulmon Dis 2006;1:251-259.
3. Dalby R et al. Med Devices: Evidence and Research 2011;4:145-155.
4. Magnussen H et al. N Engl J Med 2014;371(14):1285-1294.
5. Price D, et al. Prim Care Respir J 2013; 22: 92–100;
6. Global Initiative for Chronic Obstructive Lung Disease. Updated 2017. Available at: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/;
7. Festic E, et al. COPD 2016; 13: 312–26;
8. Loke YK, et al. Thorax 2011; 66: 699–708.
9. Calverley PMA et al. Am J Respir Crit Care Med 2017. doi:10.1164/rccm.201612-2525LE

PC-MY-100570
Production date: Mar 2019

What is 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 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.[1-4]

Tiotropium/olodaterol is administered via Respimat®, the only inhaler available that actively delivers a unique mist. This means the patient just needs to take a slow deep breath to get the medication deep into the lungs.*[5-9]
 

What is the safety profile of Spiolto® Respimat® (tiotropium/olodaterol)?

Spiolto® Respimat® (tiotropium/olodaterol) has a comparable adverse event profile to the component monotherapies.[10]

Adverse event incidence was generally balanced across all treatment groups, with the majority being mild to moderate in severity.[10]

Spiolto® Respimat® safety and tolerability profile was established in patients treated for up to 52 weeks.[10]

The proportion of patients who discontinued due to adverse events with Spiolto® Respimat® was comparable to that of Spiriva® (tiotropium) and Striverdi® (olodaterol).[10]

The percentage of patients reporting an adverse event with Spiolto® Respimat® was comparable to that of Spiriva®.[10]

For full safety profile, please refer to the Local Prescribing Information.

What are the contraindications of Spiolto® Respimat® (tiotropium/olodaterol)?[4]

Spiolto® Respimat® is contraindicated in patients with hypersensitivity to tiotropium or olodaterol or to any of the excipients.

Spiolto® Respimat® is also contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium.

For information on warnings and precautions, please refer to the Local Prescribing Information.
 
References

[1] Maltais F et al. Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD. Thorax 2014;69:A186-A187

[2] Ferguson F et al. Efficacy of tiotropium+olodaterol in patients with COPD by initial disease severity and treatment intensity: a post hoc analysis. Adv Ther. 2015; 32(6): 523-526

[3] Singh D et al. Tiotropium+olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015; 10: 1312-1319

[4] Spiolto® Respimat® Summary of Product Characteristics, February 2017

[5] Newman SP et al. 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: 957-963

[6] Pitcairn G et al. 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): 264-272

[7] Dalby R et al. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9

[8] Dalby RN et al. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155

[9] Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis 2006; 1(3): 251–259

[10] Buhl R, et al. Eur Respir J. 2015;45:969-979.

[11] Spiriva® Respimat® Summary of Product Characteristics January 2017.

[12] Striverdi® Respimat® Summary of Product Characteristics March 2016.