Dataset Information

Effect of once-daily fluticasone furoate/vilanterol versus vilanterol alone on bone mineral density in patients with COPD: a randomized, controlled trial.

ABSTRACT:

Background

The relationship between inhaled corticosteroids and bone mineral density (BMD) remains uncertain despite extensive research.

Methods

This was an international, multicenter, randomized, double-blind, parallel-group, 3-year noninferiority study. Patients with chronic obstructive pulmonary disease (COPD) (?40?years of age; smoking history ?10 pack years) and at least one native hip evaluable for BMD were enrolled and randomized 1:1, stratified by sex, to treatment with vilanterol (VI) 25?µg or fluticasone furoate/vilanterol (FF/VI) 100?µg/25?µg. BMD measurements were taken via dual-energy X-ray absorptiometry every 6?months. The primary endpoint was assessment of the noninferiority of change from baseline in total hip BMD per year at the -1% noninferiority level. Change from baseline in BMD at the lumbar spine and BMD measurements by sex were secondary endpoints. Incidences of COPD exacerbations and bone fractures throughout the study were also recorded.

Results

Of 283 randomized patients, 170 (60%) completed the study. Noninferiority was demonstrated for FF/VI versus VI with regards to change from baseline in total hip BMD per year, with changes of -0.27% and 0.18%, respectively, and a treatment difference of -0.46% per year [95% confidence interval (CI) -0.97 to 0.06]. The treatment difference for FF/VI versus VI regarding lumbar spine BMD was -0.51% per year (95% CI -1.11 to 0.10). COPD exacerbations and bone fracture rates were similar between treatment groups.

Conclusion

FF/VI showed noninferiority to VI for change from baseline in total hip BMD per year, when assessed at the -1% noninferiority margin in a combined sample of men and women with COPD.The reviews of this paper are available via the supplemental material section.

SUBMITTER: Maltais F

PROVIDER: S-EPMC7798365 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Effect of once-daily fluticasone furoate/vilanterol <i>versus</i> vilanterol alone on bone mineral density in patients with COPD: a randomized, controlled trial.

Maltais Francois F Schenkenberger Isabelle I Wielders Pascal L M L PLML Ortiz de Saracho Juan J Chinsky Kenneth K Watkins Michael M Millar Valerie V Crim Courtney C

Therapeutic advances in respiratory disease 20200101

<h4>Background</h4>The relationship between inhaled corticosteroids and bone mineral density (BMD) remains uncertain despite extensive research.<h4>Methods</h4>This was an international, multicenter, randomized, double-blind, parallel-group, 3-year noninferiority study. Patients with chronic obstructive pulmonary disease (COPD) (⩾40 years of age; smoking history ⩾10 pack years) and at least one native hip evaluable for BMD were enrolled and randomized 1:1, stratified by sex, to treatment with vi ...[more]

PMID: 33081606

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