Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

Vibeke Backer; Adam Ellery; Sylvia Borzova; Stephen Lane; Magda Kleiberova; Peter Bengtsson; Tadeusz Tomala; Dominique Basset-Stheme; Carla Bennett; Dirk Lindner; Arthur Meiners; Tim Overend

doi:10.1177/1753466618796987

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

Vibeke Backer, Adam Ellery, Sylvia Borzova, Stephen Lane, Magda Kleiberova, Peter Bengtsson, Tadeusz Tomala, Dominique Basset-Stheme, Carla Bennett, Dirk Lindner, Arthur Meiners, Tim Overend

Institut for Klinisk Medicin

4 Citationer (Scopus)

23 Downloads (Pure)

Abstract

INTRODUCTION: In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform®) was conducted.

METHODS: This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.

RESULTS: The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.

CONCLUSION: In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.

Originalsprog	Engelsk
Tidsskrift	Therapeutic Advances in Respiratory Disease
Vol/bind	12
Sider (fra-til)	1-12
ISSN	1753-4658
DOI	https://doi.org/10.1177/1753466618796987
Status	Udgivet - 1 sep. 2018

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10.1177/1753466618796987Licens: CC BY-NC

1753466618796987Forlagets udgivne version, 440 KBLicens: CC BY-NC

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Backer, V., Ellery, A., Borzova, S., Lane, S., Kleiberova, M., Bengtsson, P., Tomala, T., Basset-Stheme, D., Bennett, C., Lindner, D., Meiners, A., & Overend, T. (2018). Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management. Therapeutic Advances in Respiratory Disease, 12, 1-12. https://doi.org/10.1177/1753466618796987

Backer, V, Ellery, A, Borzova, S, Lane, S, Kleiberova, M, Bengtsson, P, Tomala, T, Basset-Stheme, D, Bennett, C, Lindner, D, Meiners, A & Overend, T 2018, 'Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management', Therapeutic Advances in Respiratory Disease, bind 12, s. 1-12. https://doi.org/10.1177/1753466618796987

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title = "Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management",

abstract = "INTRODUCTION: In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform{\textregistered}) was conducted.METHODS: This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.RESULTS: The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.CONCLUSION: In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.",

keywords = "Adolescent, Adult, Aged, Aged, 80 and over, Anti-Asthmatic Agents/administration & dosage, Asthma/drug therapy, Child, Drug Combinations, Female, Fluticasone/administration & dosage, Formoterol Fumarate/administration & dosage, Humans, Male, Middle Aged, Patient Satisfaction, Quality of Life, Treatment Outcome, Young Adult",

author = "Vibeke Backer and Adam Ellery and Sylvia Borzova and Stephen Lane and Magda Kleiberova and Peter Bengtsson and Tadeusz Tomala and Dominique Basset-Stheme and Carla Bennett and Dirk Lindner and Arthur Meiners and Tim Overend",

year = "2018",

month = sep,

day = "1",

doi = "10.1177/1753466618796987",

language = "English",

volume = "12",

pages = "1--12",

journal = "Therapeutic Advances in Respiratory Disease",

issn = "1753-4658",

publisher = "SAGE Publications",

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TY - JOUR

T1 - Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

AU - Backer, Vibeke

AU - Ellery, Adam

AU - Borzova, Sylvia

AU - Lane, Stephen

AU - Kleiberova, Magda

AU - Bengtsson, Peter

AU - Tomala, Tadeusz

AU - Basset-Stheme, Dominique

AU - Bennett, Carla

AU - Lindner, Dirk

AU - Meiners, Arthur

AU - Overend, Tim

PY - 2018/9/1

Y1 - 2018/9/1

N2 - INTRODUCTION: In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform®) was conducted.METHODS: This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.RESULTS: The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.CONCLUSION: In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.

AB - INTRODUCTION: In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform®) was conducted.METHODS: This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.RESULTS: The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.CONCLUSION: In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Anti-Asthmatic Agents/administration & dosage

KW - Asthma/drug therapy

KW - Child

KW - Drug Combinations

KW - Female

KW - Fluticasone/administration & dosage

KW - Formoterol Fumarate/administration & dosage

KW - Humans

KW - Male

KW - Middle Aged

KW - Patient Satisfaction

KW - Quality of Life

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1177/1753466618796987

DO - 10.1177/1753466618796987

M3 - Journal article

C2 - 30232933

SN - 1753-4658

VL - 12

SP - 1

EP - 12

JO - Therapeutic Advances in Respiratory Disease

JF - Therapeutic Advances in Respiratory Disease

ER -

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

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