Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care

David B Price; Victoria Carter; Jessica Martin; Elizabeth A Gardener; Derek Skinner; Sen Yang; Matthias Hoffman; Jenna C Willis; Andrew J Cooper

doi:10.1007/s40265-019-01224-8

Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care

David B Price^* (Corresponding Author), Victoria Carter, Jessica Martin, Elizabeth A Gardener, Derek Skinner, Sen Yang, Matthias Hoffman, Jenna C Willis, Andrew J Cooper

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

6 Citations (Scopus)

Abstract

OBJECTIVE: The inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform®) has been available as fixed-dose combination (FDC) therapy for asthma patients aged ≥ 12 years in the UK since 2012. This post-authorisation safety study examined adverse outcomes and prescribing practices for FP/FORM and other FDC ICS/LABA therapies in a real-life clinical setting over 36 months.

METHODS: Historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged ≥ 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models.

RESULTS: A total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM "off-label".

CONCLUSIONS: The results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.

Original language	English
Pages (from-to)	47-60
Number of pages	14
Journal	Drugs
Volume	80
Early online date	20 Nov 2019
DOIs	https://doi.org/10.1007/s40265-019-01224-8
Publication status	Published - Jan 2020

Bibliographical note

Funding
Sponsorship for this study and article processing charges was funded Mundipharma Research Ltd. Editorial assistance was provided by Karen Mower (Scientific Editorial), a member of the European Medical Writers Association (EMWA), in accordance with the CONSORT statement, and EMWA and Good Publication Practice guidelines.

The dataset analysed during the current study is available from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at: https://www.cprd.com/dataAccess/.

Keywords

EFFICACY

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Price, D. B., Carter, V., Martin, J., Gardener, E. A., Skinner, D., Yang, S., Hoffman, M., Willis, J. C., & Cooper, A. J. (2020). Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care. Drugs, 80, 47-60. https://doi.org/10.1007/s40265-019-01224-8

Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care. / Price, David B (Corresponding Author); Carter, Victoria; Martin, Jessica et al.
In: Drugs, Vol. 80, 01.2020, p. 47-60.

Research output: Contribution to journal › Article › peer-review

Price, DB, Carter, V, Martin, J, Gardener, EA, Skinner, D, Yang, S, Hoffman, M, Willis, JC & Cooper, AJ 2020, 'Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care', Drugs, vol. 80, pp. 47-60. https://doi.org/10.1007/s40265-019-01224-8

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title = "Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care",

abstract = "OBJECTIVE: The inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform{\textregistered}) has been available as fixed-dose combination (FDC) therapy for asthma patients aged ≥ 12 years in the UK since 2012. This post-authorisation safety study examined adverse outcomes and prescribing practices for FP/FORM and other FDC ICS/LABA therapies in a real-life clinical setting over 36 months.METHODS: Historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged ≥ 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models.RESULTS: A total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM {"}off-label{"}.CONCLUSIONS: The results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.",

keywords = "EFFICACY",

author = "Price, {David B} and Victoria Carter and Jessica Martin and Gardener, {Elizabeth A} and Derek Skinner and Sen Yang and Matthias Hoffman and Willis, {Jenna C} and Cooper, {Andrew J}",

note = "Funding Sponsorship for this study and article processing charges was funded Mundipharma Research Ltd. Editorial assistance was provided by Karen Mower (Scientific Editorial), a member of the European Medical Writers Association (EMWA), in accordance with the CONSORT statement, and EMWA and Good Publication Practice guidelines. The dataset analysed during the current study is available from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at: https://www.cprd.com/dataAccess/. ",

year = "2020",

month = jan,

doi = "10.1007/s40265-019-01224-8",

language = "English",

volume = "80",

pages = "47--60",

journal = "Drugs",

issn = "0012-6667",

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TY - JOUR

T1 - Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate

T2 - A 36-Month Longitudinal Cohort Study in UK Primary Care

AU - Price, David B

AU - Carter, Victoria

AU - Martin, Jessica

AU - Gardener, Elizabeth A

AU - Skinner, Derek

AU - Yang, Sen

AU - Hoffman, Matthias

AU - Willis, Jenna C

AU - Cooper, Andrew J

N1 - Funding Sponsorship for this study and article processing charges was funded Mundipharma Research Ltd. Editorial assistance was provided by Karen Mower (Scientific Editorial), a member of the European Medical Writers Association (EMWA), in accordance with the CONSORT statement, and EMWA and Good Publication Practice guidelines. The dataset analysed during the current study is available from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at: https://www.cprd.com/dataAccess/.

PY - 2020/1

Y1 - 2020/1

N2 - OBJECTIVE: The inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform®) has been available as fixed-dose combination (FDC) therapy for asthma patients aged ≥ 12 years in the UK since 2012. This post-authorisation safety study examined adverse outcomes and prescribing practices for FP/FORM and other FDC ICS/LABA therapies in a real-life clinical setting over 36 months.METHODS: Historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged ≥ 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models.RESULTS: A total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM "off-label".CONCLUSIONS: The results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.

AB - OBJECTIVE: The inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform®) has been available as fixed-dose combination (FDC) therapy for asthma patients aged ≥ 12 years in the UK since 2012. This post-authorisation safety study examined adverse outcomes and prescribing practices for FP/FORM and other FDC ICS/LABA therapies in a real-life clinical setting over 36 months.METHODS: Historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database, for patients initiated on or switched to an FDC ICS/LABA (ENCePP study number: EUPAS12330). The main cohort was adults aged ≥ 18 years with asthma. The primary outcome was incidence of new adverse outcomes after initiation of ICS/LABA; hazard ratios (HRs) and 95% confidence intervals were estimated for FP/FORM versus other FDC ICS/LABAs using Cox regression models.RESULTS: A total of 241,007 patients with an FDC ICS/LABA prescription were identified. In the adult asthma cohort (N = 41,609), the incidence rate of new adverse outcomes [in 100 patient-years (py)] was significantly lower for FP/FORM (24.75) versus fluticasone/salmeterol metered-dose inhaler [8.86; HR 1.14 (1.04, 1.25)], fluticasone/salmeterol dry powder inhaler [31.19; HR 1.18 (1.08, 1.29)], budesonide/formoterol [25.16; HR: 1.13 (1.03, 1.25)] and beclometasone/formoterol [25.47; HR 1.14 (1.04, 1.25)]. The overall prescribing rate was lower for FP/FORM (13.85 per 1000/py) than licensed FDC ICS/LABA comparators (20.30-28.13 per 1000/py). Of those prescribed FP/FORM, 80.8% were adults with asthma and < 7% were prescribed FP/FORM "off-label".CONCLUSIONS: The results suggest that FP/FORM was associated with an overall lower adverse outcome rate than the licensed comparators.

KW - EFFICACY

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U2 - 10.1007/s40265-019-01224-8

DO - 10.1007/s40265-019-01224-8

M3 - Article

C2 - 31749061

SN - 0012-6667

VL - 80

SP - 47

EP - 60

JO - Drugs

JF - Drugs

ER -

Comparative Safety Profile of the Fixed-Dose Combination Corticosteroid and Long-acting β2-Agonist Fluticasone Propionate/Formoterol Fumarate: A 36-Month Longitudinal Cohort Study in UK Primary Care

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