Fluticasone Furoate/Vilanterol Use Trends and Characteristics in Patients With Obstructive Airway Disease: A Real-World Study of 10,374 Patients From India

Introduction Obstructive Airway Diseases (OADs) are the leading cause of death among chronic respiratory diseases worldwide, and novel therapies are direly needed. Fluticasone furoate/vilanterol (FF/Vi) (100/25 µg) is the first once-daily ICS/uLABA marketed in India for COPD since 2021. Considering its limited real-world experience in OAD patients in Indian clinical settings, a large drug utilization study (DUS) was planned. Methodology We conducted a cross-sectional, observational DUS at 1900 outpatient clinics in India from October 2021 to March 2022. Prescription data and medical history of patients who were prescribed the FF/Vi combination were collected. Results It was observed that FF/Vi was prescribed in an almost equal number of patients with COPD (44.2%) and asthma (42.9%). The majority of the patients (74%) were switched from previous ICS/LABA to this ICS/uLABA, while 26% of patients were treatment naïve. The average CAT score was 19.5±7.8 (43.2% GOLD Group C and 32.2% GOLD Group B) in COPD patients, while the average ACQ-5 score was 2.6±1.3 (33.1% GINA Step 3, 29.5% GINA Step 2) in asthmatic patients. Most of the patients (63.9%) had raised biomarkers (Blood eosinophil count >300 cells/μl). Prior history of exacerbation was present in 65% of patients with annual exacerbation rates of 1.2 in COPD, 1.1 in asthma, and 1.2 in asthma-COPD overlap syndrome (ACOS). Leukotriene inhibitors (42%) and LAMAs (30.8%) were common add-on medications. Conclusion We observed a trend towards a shift to once-daily ICS/uLABA (FF/Vi) by physicians, especially in symptomatic and exacerbating OAD patients with underlying comorbidities.

[1]  I. Pavord,et al.  Fluticasone furoate: CAPTAIN of fluticasones in type 2 inflammatory asthma , 2022, Respirology.

[2]  Meilan K. Han,et al.  Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. , 2021, Chronic obstructive pulmonary diseases.

[3]  J. New,et al.  The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease , 2021, Therapeutic advances in respiratory disease.

[4]  I. Pavord,et al.  Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. , 2020, The Lancet. Respiratory medicine.

[5]  T. H. Nguyen,et al.  Prevalence and attributable health burden of chronic respiratory diseases, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017 , 2020, The Lancet. Respiratory medicine.

[6]  Y. Shimizu,et al.  Real-life effectiveness of fluticasone furoate/vilanterol after switching from fluticasone/salmeterol or budesonide/formoterol therapy in patients with symptomatic asthma: Relvar Ellipta for Real Asthma Control Study (RERACS study) , 2020, Journal of thoracic disease.

[7]  C. Janson Treatment with inhaled corticosteroids in chronic obstructive pulmonary disease , 2020, Journal of thoracic disease.

[8]  C. Janson,et al.  SABINA: An Overview of Short-Acting β2-Agonist Use in Asthma in European Countries , 2020, Advances in Therapy.

[9]  C. Janson,et al.  Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme , 2020, European Respiratory Journal.

[10]  Amit S. Gupta,et al.  Cardiovascular comorbidities associated with patients with chronic obstructive pulmonary disease – a hospital-based study , 2019 .

[11]  S. Maroufizadeh,et al.  Global prevalence of asthma-COPD overlap (ACO) in the general population: a systematic review and meta-analysis , 2019, Respiratory research.

[12]  J. New,et al.  Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford Lung Study , 2018, The Journal of asthma : official journal of the Association for the Care of Asthma.

[13]  R. Stanford,et al.  ADHERENCE WITH ONCE-DAILY FLUTICASONE FUROATE/VILANTEROL COMPARED TO TWICE-DAILY BUDESONIDE/FORMOTEROL OR FLUTICASONE PROPIONATE/SALMETEROL IN ASTHMA , 2018, Annals of Allergy, Asthma & Immunology.

[14]  M. Cazzola,et al.  LABA/LAMA fixed-dose combinations in patients with COPD: a systematic review , 2018, International journal of chronic obstructive pulmonary disease.

[15]  Stephen S. Lim,et al.  The burden of chronic respiratory diseases and their heterogeneity across the states of India: the Global Burden of Disease Study 1990–2016 , 2018, The Lancet. Global health.

[16]  N. Hanania,et al.  Asthma COPD overlap: Impact of associated comorbidities. , 2018, Pulmonary pharmacology & therapeutics.

[17]  Meilan K. Han,et al.  Once‐Daily Single‐Inhaler Triple versus Dual Therapy in Patients with COPD , 2018, The New England journal of medicine.

[18]  D. Whalley,et al.  Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD): follow-up interviews on patient-centred outcomes , 2017, npj Primary Care Respiratory Medicine.

[19]  Andrew T. Wright,et al.  Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial , 2017, The Lancet.

[20]  F. Martinez,et al.  Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. , 2017, Respiratory medicine.

[21]  Catherine Harvey,et al.  Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. , 2016, The New England journal of medicine.

[22]  K. Dwan,et al.  Vilanterol and fluticasone furoate for asthma. , 2016, The Cochrane database of systematic reviews.

[23]  P. Montuschi,et al.  Vilanterol trifenatate for the treatment of COPD , 2016, Expert review of respiratory medicine.

[24]  S. Petersen,et al.  Lung Deflation and Cardiovascular Structure and Function in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. , 2016, American journal of respiratory and critical care medicine.

[25]  P. Kuna,et al.  Achieving asthma control with ICS/LABA: A review of strategies for asthma management and prevention. , 2016, Respiratory medicine.

[26]  M. Fujimura,et al.  A comparison of the efficacy of once-daily fluticasone furoate/vilanterole with twice-daily fluticasone propionate/salmeterol in asthma-COPD overlap syndrome. , 2015, Pulmonary pharmacology & therapeutics.

[27]  I. Pavord,et al.  Blood eosinophil counts, exacerbations, and response to the addition of inhaled fluticasone furoate to vilanterol in patients with chronic obstructive pulmonary disease: a secondary analysis of data from two parallel randomised controlled trials. , 2015, The Lancet. Respiratory medicine.

[28]  P. Daley-Yates Inhaled corticosteroids: potency, dose equivalence and therapeutic index , 2015, British journal of clinical pharmacology.

[29]  T. Albertson,et al.  Patient considerations in the treatment of COPD: focus on the new combination inhaler umeclidinium/vilanterol , 2015, Patient preference and adherence.

[30]  E. Kerwin,et al.  A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. , 2013, Respiratory medicine.

[31]  T. Lasserson,et al.  Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease. , 2012, The Cochrane database of systematic reviews.

[32]  A. Tattersfield,et al.  Plasma concentrations of inhaled corticosteroids in relation to airflow obstruction in asthma. , 2006, British journal of clinical pharmacology.

[33]  W. Bailey,et al.  Editorial: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Guidelines for COPD, Including COVID-19, Climate Change, and Air Pollution , 2023, Medical science monitor : international medical journal of experimental and clinical research.