scholarly journals The Role of ICS/LABA Fixed-Dose Combinations in the Treatment of Asthma and COPD: Bioequivalence of a Generic Fluticasone Propionate-Salmeterol Device

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Donald P. Tashkin ◽  
Jill A. Ohar ◽  
Arkady Koltun ◽  
Richard Allan ◽  
Jonathan K. Ward

Both asthma and chronic obstructive pulmonary disease (COPD) are inflammatory chronic respiratory conditions with high rates of morbidity and mortality worldwide. The objectives of this review are to briefly describe the pathophysiology and epidemiology of asthma and COPD, discuss guideline recommendations for uncontrolled disease, and review a new generic option for the treatment of asthma and COPD. Although mild forms of these diseases may be controlled with as-needed pharmacotherapy, uncontrolled or persistent asthma and moderate or severe COPD uncontrolled by bronchodilators with elevated eosinophilia or frequent exacerbations may require intervention with combination therapy with inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs), according to international guidelines. Fixed-dose combinations of ICS/LABA are commonly prescribed for both conditions, with fluticasone propionate (FP) and salmeterol forming a cornerstone of many treatment plans. An oral inhalation powder containing the combination of FP and salmeterol has been available as Advair Diskus® in the United States for almost 20 years, and the first and only substitutable generic version of this product has recently been approved for use: Wixela™ Inhub™. Bioequivalence of Wixela Inhub and Advair Diskus has been established. Furthermore, the Inhub inhaler was shown to be robust and easy to use, suggesting that Wixela Inhub may provide an alternative option to Advair Diskus for patients with asthma or COPD requiring intervention with an ICS/LABA.


Author(s):  
Stan Ejiofor ◽  
Alice M. Turner

This review article summarizes the main treatments for chronic obstructive pulmonary disease, their mechanisms, and the key evidence from trials supporting their use. Drug classes covered were short acting beta agonists (SABA), short acting muscarinic antagonists (SAMA), long acting beta agonists (LABA), long acting antimuscarinics (LAMA), inhaled corticosteroids (ICS), LABA/ ICS combinations, specific phosphodiesterase (PDE4) inhibitors, non-specific PDE inhibitors, mucolytics, and oxygen. Non-specific therapies, such as opiates for relief of dyspnoea and therapies for smoking cessation, are also covered briefly. For each class of drug, mechanisms of action are described, key clinical trial results are reported, and available agents compared. Finally, the place of each drug in therapy is compared between current worldwide guidelines.



2018 ◽  
Vol 96 (3) ◽  
pp. 257-261
Author(s):  
Anna G. Romanovskikh ◽  
Yu. G. Belotserkovskaya ◽  
I. P. Smirnov

Chronic obstructive pulmonary disease (COPD) is an urgent problem of modern healthcare. One of the most frequent approaches to the therapy of the COPD remains the appointment of inhaled corticosteroids (ICSs) and long-acting β2-agonists (LABAs) in fixed-dose combinations. At the same time, the role and place of fixed-dose combinations (ICS/LABA) in COPD therapy is currently being actively discussed. The presented article describes the efficacy and safety of fixed-dose combinations (ICS/LABA) in COPD patients, modern approaches to the appointment of ICS/LABA.



ESC CardioMed ◽  
2018 ◽  
pp. 1050-1053
Author(s):  
Jennifer Quint

The mainstay of pharmacological treatment of chronic obstructive pulmonary disease (COPD) treatment is inhalers, consisting of bronchodilators, both long-acting muscarinic antagonists and long-acting beta agonists, and inhaled corticosteroids. While the muscarinic antagonists and beta agonists act to open up the airways and have bronchodilating effects on smooth muscle thus decreasing breathlessness, inhaled corticosteroids dampen down the inflammatory process. COPD is considered a systemic disease and is associated with cardiovascular co-morbidities, but people with COPD who have cardiovascular disease (CVD) are often the very patients who are excluded from participating in randomized controlled trials of these medications thus making ascertainment of the true relationship between CVD and COPD treatments difficult. Trials suggest that long-acting muscarinic antagonists and long-acting beta agonists are safe when used in appropriate doses in people with COPD who do not have uncontrolled CVD, but in patients with underlying CVD or who use higher doses or more pharmacologically active medications the implications are less clear. Some people would argue that the data that currently exist from trials are not representative of real life and the long-term safety of COPD treatments is not known in the people in whom it matters most.



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