Real-World Effectiveness of GIOTRIF® vs Osimertinib - Data from Japan
Document ID: PC-SG-101881
21/07/2023
Author: Boehringer Ingelheim
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PC-SG-101881
Production date: Apr 2023
Production date: Apr 2023
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]
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.
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.
[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.