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Evidence Derived from Real-World Data: Utility, Constraints, and Cautions
Published in Harry Yang, Binbing Yu, Real-World Evidence in Drug Development and Evaluation, 2021
Other examples of RWE generation from RWD are increasingly populating the literature. An often-cited example is the “Salford Lung Study (SLS)” (Bakerly et al. 2015). The SLS collected EHR data and assessed effectiveness and safety of fluticasone furoate in COPD patients in the United Kingdom. Seventy-five general practitioner clinics, 128 community pharmacies in Salford and South Manchester, and two hospitals participated in a 12-month, open-label, phase 3 study in which 2,799 patients were randomized 1:1 to a once-daily inhaled combination of fluticasone furoate 100 µg and vilanterol 25 µg, or to a continuation of their existing therapy. For a detailed discussion of the SLS case study, and another large observational study on amyotrophic lateral sclerosis (ALS) conducted by PatientsLikeMe, readers are referred to Khosla et al. (2018). In another recently-published review, Webster and Smith (2019) made a case for using RWE in chronic myeloid leukemia (CML). They reported that in CML, RWE has informed early treatment milestones and has provided a window into patient perspectives regarding treatment, and that such information from the real world will help clinicians to better optimize treatments. Thus, RWD and RWE are already aiding clinical decisions and generating insights that are relevant across the healthcare ecosystem.
Nasal problems in the athlete
Published in John W. Dickinson, James H. Hull, Complete Guide to Respiratory Care in Athletes, 2020
A number of useful guidelines exist concerning the pharmacological management of allergic rhinitis. The ARIA (Allergic Rhinitis and its Impact on Asthma) document provides a simple system for classification and treatment; the BSACI (British Society of Allergy and Clinical Immunology) has recently published updated detailed guidelines and associated algorithm. In brief, mild symptoms can be treated with an as-required non-sedating anti-histamine, but anything more persistent or troublesome should be treated with an intranasal corticosteroid (see Table 8.1). Nasal corticosteroids are more effective than anti-histamines and the combination of anti-histamine and anti-leukotriene (e.g. montelukast). Many preparations are available, but newer drugs with lower systemic bioavailability (mometasone furoate, fluticasone propionate, fluticasone furoate) are preferable. Regular use and correct application are essential for optimal benefit (Figure 8.5). Failure to respond to an intranasal steroid alone should prompt consideration of a combined corticosteroid plus topical anti-histamine preparation. Anti-cholinergic sprays (ipratropium bromide) can help reduce watery rhinorrhoea. Intranasal steroids also have a beneficial effect on allergic conjunctivitis, but more troublesome symptoms warrant treatment with topical sodium cromoglicate, nedocromil sodium or topical antihistamine (azelastine, olopatadine). Athletes should be treated along the same lines.
Pharmacokinetics and Pharmacodynamics of Drugs Delivered to the Lung
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Stefanie K. Drescher, Mong-Jen Chen, Jürgen B. Bulitta, Günther Hochhaus
A significant portion of drug delivered by MDI or DPI (40%–90%) reaches the GI tract. The overall amount depends on how much drug is deposited in the oropharynx and swallowed, and how much pulmonary deposited drug is removed from the lung by mucociliary clearance which ultimately reaches the GI tract. The oral bioavailability of the drug (F), which is affected by the hepatic or pre-hepatic first pass effect, determines how much drug enters the systemic circulation from the GI tract. Figure 6.6 illustrates that a drug with lower oral bioavailability is more effective in promoting pulmonary targeting. Fluticasone propionate (FP), ciclesonide, fluticasone furoate, and mometasone furoate have been reported to have a low oral bioavailability of less than 1% (Ventresca et al. 1994; Falcoz et al. 1996). Bioavailabilities of currently used inhaled glucocorticoids range from <1% to 40% (Ryrfeldt et al. 1982; Hochhaus et al. 1992a; Derendorf et al. 1995; Dickens et al. 1999; Daley-Yates et al. 2001). Similarly, oral bioavailabilities of short-acting beta-2-adrenergic drugs vary significantly, from 1.5% to approximately 50% (Hochhaus and Möllmann 1995). These differences likely affect the degree of pulmonary selectivity. According to Rohatagi et al., oral bioavailabilities of approximately 25% or less should not induce clinically relevant systemic side effects as long as a large pulmonary deposition is responsible for a limited amount of drug being swallowed (Rohatagi et al. 1999).
Symptom control in patients with asthma using inhaled corticosteroids/long-acting β2-agonists (fluticasone furoate/vilanterol or budesonide/formoterol) in the US: a retrospective matched cohort study
Published in Journal of Asthma, 2022
Carlyne M. Averell, François Laliberté, Guillaume Germain, Mei Sheng Duh, Robson Lima, Malena Mahendran, David J. Slade
Fluticasone furoate/vilanterol (FF/VI) is an ICS/LABA combination therapy licensed for the once-daily treatment of asthma in adults and adolescents aged ≥12 years in Europe (14) and in adults aged ≥18 years in the United States (US) (15). FF/VI is recommended by GINA as an alternative controller therapy for Step 3 (2). Once-daily use of FF/VI 100/25 mcg has been shown to reduce the risk of severe exacerbations (defined by the European Respiratory Society/American Thoracic Society [ERS/ATS] Task Force as “events that require systemic corticosteroids for ≥3 days and/or hospitalization/emergency room visit for asthma requiring systemic corticosteroids” (10)) and significantly improve lung function compared with FF alone (16). Another study demonstrated that use of FF/VI 100/25 mcg is associated with significant improvement in symptom control, compared with usual care (other ICS ± LABA) (17). Furthermore, data from a UK-based real-world study have demonstrated that FF/VI 100/25 mcg improves asthma control and reduces the risk of exacerbations, in addition to improving quality of life, compared with usual care (other ICS/LABA) (18).
Evaluating fluticasone furoate + vilanterol for the treatment of chronic obstructive pulmonary disease (COPD)
Published in Expert Opinion on Pharmacotherapy, 2019
Fluticasone furoate (FF) is a longer acting inhaled corticosteroid with more potent anti-inflammatory action as compared to other inhaled steroids [14]. FF has a longer duration of action then Fluticasone propionate and Budesonide because of the enhanced occupation of a discrete pocket on the glucocorticoid receptor and longer lung residency [15]. FF also is more resistant to oxidative stress than Fluticasone propionate [16]. A study of FF in five healthy, male subjects [17] revealed that oral bioavailability is low at 1.6% due to extensive hepatic first-pass metabolism. FF is primarily metabolized in the liver. However, following inhalation, FF had a longer ½ life of 17–24 h [18] as compared to after intravenous administration (14 h), thus suggesting prolonged absorption of FF from the lungs into the systemic circulation. This is compared to approximately 9–11 h for fluticasone propionate and allowed for daily dosing [19].
Fluticasone furoate, umeclidinium bromide, and vilanterol as a combination therapy for chronic obstructive pulmonary disease
Published in Expert Review of Respiratory Medicine, 2018
Giulia Parri, Dario Nieri, Maria Adelaide Roggi, Barbara Vagaggini, Alessandro Celi, Pierluigi Paggiaro
The value of FF/VI combination has been already demonstrated both in asthma and COPD, where this combination has shown a better efficacy when compared with ICS or LABA alone [24–26] and a similar efficacy when compared with FP/SALM combination [27,28]. Due to the pharmacologic characteristics of fluticasone furoate (FF), a newest ICS characterized by a high receptor affinity and a long retention time in the airways, the equivalent dose of FF vs. other ICS was very low, with almost null systemic retention [29]. The combination with vilanterol (VI), a very long acting bronchodilator with a rapid onset of action similar to formoterol [30], has allowed the once-daily administration with the possibility to cover all 24 hours as regards both bronchodilation and anti-inflammatory effect. Together with the new device Ellipta, which has improved the characteristics of the Diskus also in terms of inhaled particles dimension [31], this formulation has all the characteristics for improving adherence of the patients to the prescribed long-term regular treatment.