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Long-term safety of tiotropium delivered by Respimat ® SoftMist ™ Inhaler: patient selection and special considerations

View Article: PubMed Central - PubMed

ABSTRACT

Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler® dry powder inhaler (DPI) device, and since 2007 as the Respimat® SoftMist™ Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI. Although tiotropium bromide delivered via the HandiHaler DPI has been clearly shown to improve lung function, dyspnea, and quality of life and to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD), there is accumulating evidence regarding the use of tiotropium HandiHaler in other respiratory diseases characterized by airflow limitation, such as asthma and cystic fibrosis. Developed more recently, tiotropium delivered via the Respimat SMI appears to have a similar efficacy and safety profile to the HandiHaler DPI, and early data raising the possibility of safety concerns with its use in COPD have been refuted by more recent evidence. The benefits over the HandiHaler DPI, however, remain unclear. This paper will review the evidence for tiotropium delivered via the Respimat SMI inhaler, in particular as an alternative to the HandiHaler DPI, and will focus on the safety profile for each of the chronic lung diseases in which it has been trialed, as well as an approach to appropriate patient selection.

No MeSH data available.


Related in: MedlinePlus

GINA guidelines for management of asthma.Notes: Note the recommendation to add tiotropium in steps 4 and 5, after maximizing other medical therapy. Reproduced with permission from Global Initiative for Asthma (GINA) Teaching Slide Set, 2015 Update (Slide 63).33 aFor children 6–11 years, theophylline is not recommended, and preferred Step 3 is medium-dose ICS. bFor patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy. cTiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years.Abbreviations: BDP, beclomethasone dipropionate; BUD, budesonide; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids; LABA, long-acting β-2 agonist; theoph, theophylline; IgE, Immunoglobulin E; OCS, oral corticosteroid.
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f2-tcrm-12-1433: GINA guidelines for management of asthma.Notes: Note the recommendation to add tiotropium in steps 4 and 5, after maximizing other medical therapy. Reproduced with permission from Global Initiative for Asthma (GINA) Teaching Slide Set, 2015 Update (Slide 63).33 aFor children 6–11 years, theophylline is not recommended, and preferred Step 3 is medium-dose ICS. bFor patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy. cTiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years.Abbreviations: BDP, beclomethasone dipropionate; BUD, budesonide; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids; LABA, long-acting β-2 agonist; theoph, theophylline; IgE, Immunoglobulin E; OCS, oral corticosteroid.

Mentions: In most guidelines, tiotropium is suggested for asthmatic patients with persisting evidence of disease activity despite being established in alternative inhaled regimens. The GINA (Global Initiative for Asthma) guidelines recommend adding tiotropium if an adult patient’s symptoms are not controlled by medium- or high-dose ICS (2,000 μg beclomethasone equivalent) plus long-acting β-2-agonist therapy (Figure 2).33 The American Thoracic Society guidelines state that the use of long-acting muscarinic antagonists should be reserved only for moderate-to-severe asthmatics.34 Such recommendations are corroborated by the manufacturer’s recommendation.35 A meta-analysis conducted in 201522 found that the benefit of tiotropium is greatest in patients with poorly controlled asthma. They found that while tiotropium confers spirometric improvement in asthma patients regardless of severity, patients with severe asthma demonstrated larger benefits, particularly improvement in the quality of life.22 Although data from these trials and guidelines appear to encourage the use of tiotropium in poorly controlled asthmatics, it should be noted that these trials often have strict exclusion criteria. In particular, patients with underlying cardiac disorders are often excluded. Given the small increase in adverse events with increasing doses of tiotropium,36 caution should be exercised before prescribing tiotropium in patients with underlying cardiac disease. Attempts should also be made to ensure compliance with existing therapy prior to adding further agents to existing therapy regimes, as it has been reported that up to 80% of patients with poorly controlled asthma have poor compliance rates.36


Long-term safety of tiotropium delivered by Respimat ® SoftMist ™ Inhaler: patient selection and special considerations
GINA guidelines for management of asthma.Notes: Note the recommendation to add tiotropium in steps 4 and 5, after maximizing other medical therapy. Reproduced with permission from Global Initiative for Asthma (GINA) Teaching Slide Set, 2015 Update (Slide 63).33 aFor children 6–11 years, theophylline is not recommended, and preferred Step 3 is medium-dose ICS. bFor patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy. cTiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years.Abbreviations: BDP, beclomethasone dipropionate; BUD, budesonide; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids; LABA, long-acting β-2 agonist; theoph, theophylline; IgE, Immunoglobulin E; OCS, oral corticosteroid.
© Copyright Policy
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5036544&req=5

f2-tcrm-12-1433: GINA guidelines for management of asthma.Notes: Note the recommendation to add tiotropium in steps 4 and 5, after maximizing other medical therapy. Reproduced with permission from Global Initiative for Asthma (GINA) Teaching Slide Set, 2015 Update (Slide 63).33 aFor children 6–11 years, theophylline is not recommended, and preferred Step 3 is medium-dose ICS. bFor patients prescribed BDP/formoterol or BUD/formoterol maintenance and reliever therapy. cTiotropium by soft-mist inhaler is indicated as add-on treatment for patients with a history of exacerbations; it is not indicated in children <18 years.Abbreviations: BDP, beclomethasone dipropionate; BUD, budesonide; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids; LABA, long-acting β-2 agonist; theoph, theophylline; IgE, Immunoglobulin E; OCS, oral corticosteroid.
Mentions: In most guidelines, tiotropium is suggested for asthmatic patients with persisting evidence of disease activity despite being established in alternative inhaled regimens. The GINA (Global Initiative for Asthma) guidelines recommend adding tiotropium if an adult patient’s symptoms are not controlled by medium- or high-dose ICS (2,000 μg beclomethasone equivalent) plus long-acting β-2-agonist therapy (Figure 2).33 The American Thoracic Society guidelines state that the use of long-acting muscarinic antagonists should be reserved only for moderate-to-severe asthmatics.34 Such recommendations are corroborated by the manufacturer’s recommendation.35 A meta-analysis conducted in 201522 found that the benefit of tiotropium is greatest in patients with poorly controlled asthma. They found that while tiotropium confers spirometric improvement in asthma patients regardless of severity, patients with severe asthma demonstrated larger benefits, particularly improvement in the quality of life.22 Although data from these trials and guidelines appear to encourage the use of tiotropium in poorly controlled asthmatics, it should be noted that these trials often have strict exclusion criteria. In particular, patients with underlying cardiac disorders are often excluded. Given the small increase in adverse events with increasing doses of tiotropium,36 caution should be exercised before prescribing tiotropium in patients with underlying cardiac disease. Attempts should also be made to ensure compliance with existing therapy prior to adding further agents to existing therapy regimes, as it has been reported that up to 80% of patients with poorly controlled asthma have poor compliance rates.36

View Article: PubMed Central - PubMed

ABSTRACT

Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler&reg; dry powder inhaler (DPI) device, and since 2007 as the Respimat&reg; SoftMist&trade; Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI. Although tiotropium bromide delivered via the HandiHaler DPI has been clearly shown to improve lung function, dyspnea, and quality of life and to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD), there is accumulating evidence regarding the use of tiotropium HandiHaler in other respiratory diseases characterized by airflow limitation, such as asthma and cystic fibrosis. Developed more recently, tiotropium delivered via the Respimat SMI appears to have a similar efficacy and safety profile to the HandiHaler DPI, and early data raising the possibility of safety concerns with its use in COPD have been refuted by more recent evidence. The benefits over the HandiHaler DPI, however, remain unclear. This paper will review the evidence for tiotropium delivered via the Respimat SMI inhaler, in particular as an alternative to the HandiHaler DPI, and will focus on the safety profile for each of the chronic lung diseases in which it has been trialed, as well as an approach to appropriate patient selection.

No MeSH data available.


Related in: MedlinePlus