Comparative Effectiveness of Budesonide-Formoterol Combination and Fluticasone-Salmeterol Combination for Asthma Management: A United States Retrospective Database Analysis

Tunceli, Ozgur; Williams, Setareh A.; Kern, David M.; Elhefni, Hanaa; Pethick, Ned; Wessman, Catrin; Zhou, Siting; Trudo, Frank

doi:10.1016/j.jaip.2014.07.016

Cited by 12 publications

(17 citation statements)

References 7 publications

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“…Similar results were obtained when patients received twice-daily maintenance therapy with budesonide/formoterol from a single inhaler [108]. A large real-world study using a retrospective matched cohort population database analysis showed lower rates of exacerbation and healthcare utilisation with the budesonide/formoterol combination than with salmeterol/fluticasone in asthma [109]. This combination treatment was first approved for use in asthma in 2001 and is currently available in a choice of pMDI or DPI devices.…”

Section: Budesonide/formoterol Studies In Asthmamentioning

confidence: 61%

Benefit:Risk Profile of Budesonide in Obstructive Airways Disease

Tashkin

Lipworth

Brattsand³

2019

Drugs

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Airway inflammation is a major contributing factor in both asthma and chronic obstructive pulmonary disease (COPD) and represents an important target for treatment. Inhaled corticosteroids (ICS) as monotherapy or in combination therapy with long-acting β 2-agonists or long-acting muscarinic antagonists are used extensively in the treatment of asthma and COPD. The development of ICS for their anti-inflammatory properties progressed through efforts to increase topical potency and minimise systemic potency and through advances in inhaled delivery technology. Budesonide is a potent, non-halogenated ICS that was developed in the early 1970s and is now one of the most widely used lung medicines worldwide. Inhaled budesonide's physiochemical and pharmacokinetic/pharmacodynamic properties allow it to reach a rapid and high airway efficacy due to its more balanced relationship between water solubility and lipophilicity. When absorbed from the airways and lung tissue, its moderate lipophilicity shortens systemic exposure, and its unique property of intracellular esterification acts like a sustained release mechanism within airway tissues, contributing to its airway selectivity and a low risk of adverse events. There is a large volume of clinical evidence supporting the efficacy and safety of budesonide, both alone and in combination with the fast-and long-acting β 2-agonist formoterol, as maintenance therapy in patients with asthma and with COPD. The combination of budesonide/formoterol can also be used as an as-needed reliever with anti-inflammatory properties, with or without regular maintenance for asthma, a novel approach that is already approved by some country-specific regulatory authorities and currently recommended in the Global Initiative for Asthma (GINA) guidelines. Budesonide remains one of the most well-established and versatile of the inhaled anti-inflammatory drugs. This narrative review provides a clinical reappraisal of the benefit:risk profile of budesonide in the management of asthma and COPD.

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Section: Budesonide/formoterol Studies In Asthmamentioning

confidence: 61%

Benefit:Risk Profile of Budesonide in Obstructive Airways Disease

Tashkin

Lipworth

Brattsand³

2019

Drugs

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“…However, certain reports [14–16] describe differences in clinical efficacy between Symbicort and ADVAIR. Nevertheless, these assessments are challenging because clinical symptom scores are unstable and the clinical visit continuity is very low [17].…”

Section: Discussionmentioning

confidence: 99%

Dry Powder and Budesonide Inhalation Suspension Deposition Rates in Asthmatic Airway-Obstruction Regions

Murayama

Asai

Murayama

et al. 2019

Journal of Drug Delivery

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Steroid inhalation is the standard bronchial asthma therapy and it includes powdered metered doses, dry powder, and nebulizer suspension. However, particle sizes vary widely. The research goal was to demonstrate that different budesonide administration forms and devices have various deposition rates in the airway obstruction region. Here, we compared relative inhalation therapy efficacies and identified therapies that delivered the highest drug doses to the airway obstruction region. Weibel's anatomy data were used to identify the airway obstruction region in asthma. Based on European Standardization Committee data, we investigated the diameters of the drug particles being deposited there and evaluated the average particle size and distribution of the budesonide dosage forms and application devices. Drug dose depositions were measured by HPLC at each stage of a Cascade Impactor. Weibel's anatomy data indicated that the 1st–4th bronchial generations comprised the airway obstruction region and corresponded to the tracheobronchial area. According to the European Standardization, particles 2–6 µm in diameter were readily deposited there. The proportions of particles in this size range were 33.0%, 32.0%, 59.0%, and 78.0% for Turbuhaler, Symbicort, mesh-type NE-U22 suspension, and jet-type NE-C28 suspension, respectively. We localized the airway obstruction regions of bronchial asthma and identified the optimal inhalation therapy particle size. An electric nebulizer was more efficacious for budesonide administration than dry powder delivery. The NE-C28 treatment deposited 2.36x more budesonide in the airway obstruction region than dry powder delivery systems.

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“…Within the respiratory field retrospective studies using databases and or electronic medical records have dominated [16][17][18][19]. Comparisons between different treatment regimens have been made by matching patients using different statistical methods.…”

Section: Types Of Effectiveness Trialsmentioning

confidence: 99%

Effectiveness trials: critical data to help understand how respiratory medicines really work?

Heddini

Sundh

Ekström

et al. 2019

European Clinical Respiratory Journal

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Most of the information about the benefits, safety aspects, and cost effectiveness of pharmacological treatment in the respiratory field has been obtained from traditional efficacy studies, such as randomised controlled trials (RCT). The highly controlled environment of an RCT does not always reflect everyday practice. The collection, analysis, and application of effectiveness data to generate Real World Evidence (RWE) through pragmatic trials or observational studies therefore has the potential to improve decision making by regulators, payers, and clinicians.Despite calls for more RWE, effectiveness data are not widely used in decision making in the respiratory field. Recent advances in data capture, curation, and storage combined with new analytical tools have now made it feasible for effectiveness data to become routine sources of evidence to supplement traditional efficacy data. In this paper, we will examine some of the current data gaps, diverse types of effectiveness data, look at proposed frameworks for the positioning of effectiveness data, as well as provide examples from therapeutic areas. We will give examples of both previous effectiveness studies and studies that are ongoing within the respiratory field. Effectiveness data hold the potential to address several evidentiary gaps related to the effectiveness, safety, and value of treatments in patients with respiratory diseases.

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Comparative Effectiveness of Budesonide-Formoterol Combination and Fluticasone-Salmeterol Combination for Asthma Management: A United States Retrospective Database Analysis

Cited by 12 publications

References 7 publications

Benefit:Risk Profile of Budesonide in Obstructive Airways Disease

Benefit:Risk Profile of Budesonide in Obstructive Airways Disease

Dry Powder and Budesonide Inhalation Suspension Deposition Rates in Asthmatic Airway-Obstruction Regions

Effectiveness trials: critical data to help understand how respiratory medicines really work?

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