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Multicenter Study
. 2020 Jan-Dec:14:1753466620965145.
doi: 10.1177/1753466620965145.

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

Francois Maltais  1 , Isabelle Schenkenberger  2 , Pascal L M L Wielders  3 , Juan Ortiz de Saracho  4 , Kenneth Chinsky  5 , Michael Watkins  6 , Valerie Millar  7 , Courtney Crim  8
Affiliations
Multicenter Study

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

Francois Maltais et al. Ther Adv Respir Dis. 2020 Jan-Dec.

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.

Keywords: bone density; chronic obstructive pulmonary disease; fractures; inhaled corticosteroids; lumbar spine.

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Conflict of interest statement

Conflict of interest statement: FM has received honoraria for giving a lecture or attending an advisory board for Boehringer Ingelheim , GlaxoSmithKline plc., Novartis, and Grifols. He has also received research grants for participating in multicenter trials for AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline plc., Sanofi, and Novartis, and has received unrestricted research grants and personal fees from Boehringer Ingelheim, Grifols, and Novartis. KC has been, but is not currently, a speaker for GlaxoSmithKline plc., and is currently listed as a speaker for Boehringer Ingelheim. MW, VM, and CC are employees of, and hold shares in, GlaxoSmithKline plc.

Figures

Figure 1.
Figure 1.
Flow diagram of patient disposition. FF/VI, fluticasone furoate/vilanterol; VI, vilanterol.
Figure 2.
Figure 2.
Study design. FF/VI, fluticasone furoate/vilanterol; OD, once daily; VI, vilanterol.
Figure 3.
Figure 3.
(a) Adjusted percentage change from baseline in on-treatment bone mineral density (g/cm2) at the total hip over time (primary endpoint, safety population); (b) adjusted yearly rate of change from baseline between FF/VI and VI in on-treatment bone mineral density (g/cm2) at the total hip. The prespecified noninferiority margin of −1% is indicated by the dotted blue line. Any values to the right of this line are noninferior. CI, confidence interval; FF/VI, fluticasone furoate/vilanterol; VI, vilanterol.
Figure 4.
Figure 4.
Adjusted percentage change from baseline in on-treatment bone mineral density (g/cm2) at the lumbar spine over time (secondary endpoint, safety population). CI, confidence interval; FF/VI, fluticasone furoate/vilanterol; VI, vilanterol.
See this image and copyright information in PMC

References

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