Real-World Effectiveness of GIOTRIF® vs Osimertinib - Data from Japan
21/07/2023 | Author: Boehringer Ingelheim
Document ID: PC-SG-101881
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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:
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[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.
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[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.
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[3]
Singh D et al. Tiotropium+olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015; 10: 1312-1319.
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[4]
Spiolto® Respimat® Summary of Product Characteristics, February 2017.
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[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.
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[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.
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[7]
Dalby R et al. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004; 283: 1-9.
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[8]
Dalby RN et al. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011; 4: 145-155.
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[9]
Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis 2006; 1(3): 251-259.
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[10]
Buhl R, et al. Eur Respir J. 2015;45:969-979.
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[11]
Spiriva® Respimat® Summary of Product Characteristics January 2017.
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[12]
Striverdi® Respimat® Summary of Product Characteristics March 2016.