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Osteoporosis and fracture risk associated with inhaled corticosteroid use among Swedish COPD patients: the ARCTIC study

Christer Janson, Karin Lisspers, Björn Ställberg, Gunnar Johansson, Florian S. Gutzwiller, Karen Mezzi, Linda Mindeholm, Bine Kjoeller Bjerregaard, Leif Jorgensen, Kjell Larsson
European Respiratory Journal 2021 57: 2000515; DOI: 10.1183/13993003.00515-2020
Christer Janson
1Respiratory, Allergy and Sleep Research, Dept of Medical Sciences, Uppsala University, Uppsala, Sweden
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  • For correspondence: christer.janson@medsci.uu.se
Karin Lisspers
2Family Medicine and Preventive Medicine, Dept of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden
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Björn Ställberg
2Family Medicine and Preventive Medicine, Dept of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden
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Gunnar Johansson
2Family Medicine and Preventive Medicine, Dept of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden
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Florian S. Gutzwiller
3Novartis Pharma AG, Basel, Switzerland
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Karen Mezzi
3Novartis Pharma AG, Basel, Switzerland
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Linda Mindeholm
4Novartis Institutes for Biomedical Research (NIBR), Cambridge, MA, USA
5Novartis Institutes for Biomedical Research (NIBR), Basel, Switzerland
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Bine Kjoeller Bjerregaard
6IQVIA Solutions, Copenhagen, Denmark
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Leif Jorgensen
6IQVIA Solutions, Copenhagen, Denmark
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Kjell Larsson
7Intergrative Toxicology, National Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden
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Abstract

The effect of inhaled corticosteroids (ICS) on the risk of osteoporosis and fracture in patients with chronic obstructive pulmonary disease (COPD) remains uncertain. The aim of this study was to assess this risk in patients with COPD.

Electronic medical record data linked to National Health Registries were collected from COPD patients and matched reference controls at 52 Swedish primary care centres from 2000 to 2014. The outcomes analysed were the effect of ICS on all fractures, fractures typically related to osteoporosis, recorded osteoporosis diagnosis, prescriptions of drugs for osteoporosis and a combined measure of any osteoporosis-related event. The COPD patients were stratified by the level of ICS exposure.

A total of 9651 patients with COPD and 59 454 matched reference controls were analysed. During the follow-up, 19.9% of COPD patients had at least one osteoporosis-related event compared with 12.9% of reference controls (p<0.0001). Multivariate analysis in the COPD population demonstrated a dose–effect relationship, with high-dose ICS being significantly associated with any osteoporosis-related event (risk ratio 1.52 (95% CI 1.24–1.62)), while the corresponding estimate for low-dose ICS was 1.27 (95% CI 1.13–1.56) compared with COPD patients not using ICS. A similar dose-related adverse effect was found for all four of the specific osteoporosis-related events: all fractures, fractures typically related to osteoporosis, prescriptions of drugs for osteoporosis and diagnosis of osteoporosis.

We conclude that patients with COPD have a greater risk of bone fractures and osteoporosis, and high-dose ICS use increased this risk further.

Abstract

COPD patients are at high risk of fractures and osteoporosis. ICS use, especially at high doses, increases this risk further. It is therefore important to pinpoint which patients benefit from ICS to reduce unnecessary exposure to ICS-associated risks. https://bit.ly/34V3OeW

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • Data availability: The data for this study were obtained from electronic medical records in primary care and the Swedish National Health Register. Restrictions apply to the availability of these data, which were used under licence for the current study and so are not publicly available. Data are, however, available from IQVIA Solutions, Solna, Sweden (E-mail: binekjoeller.bjerregaard{at}iqvia.com), upon reasonable request and with permission of the Swedish National Health Register.

  • Author contributions: All authors participated equally in the study conception, design, statistical analysis planning, analysis and interpretation of the data, and have reviewed and approved the manuscript.

  • Conflict of interest: C. Janson reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis and Teva, outside the submitted work.

  • Conflict of interest: K. Lisspers reports personal fees from AstraZeneca, Novartis, Boehringer Ingelheim, GlaxoSmithKline and Chiesi, outside the submitted work.

  • Conflict of interest: B. Ställberg reports personal fees from AstraZeneca, Novartis, Boehringer Ingelheim, GlaxoSmithKline, Meda, Teva and Chiesi, outside the submitted work.

  • Conflict of interest: G. Johansson has nothing to disclose.

  • Conflict of interest: F.S. Gutzwiller is an employee of Novartis Pharma AG.

  • Conflict of interest: K. Mezzi is an employee of Novartis Pharma AG.

  • Conflict of interest: L. Mindeholm is a consultant to Novartis, and shareholder of Novartis, Alcon and Novo-Nordisk.

  • Conflict of interest: B.K. Bjerregaard is an employee of IQVIA and received remuneration in relation to statistical analyses.

  • Conflict of interest: L. Jörgensen is an employee of IQVIA.

  • Conflict of interest: K. Larsson has, during the last 5 years, on one or more occasion served in an advisory board, served as a speaker and/or participated in education activities arranged by AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Takeda, Novartis, Chiesi, Orion and Teva.

  • Support statement: This study was funded by Novartis Pharma AG (Basel, Switzerland).

  • Received March 1, 2020.
  • Accepted August 26, 2020.
  • Copyright ©ERS 2021
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Osteoporosis and fracture risk associated with inhaled corticosteroid use among Swedish COPD patients: the ARCTIC study
Christer Janson, Karin Lisspers, Björn Ställberg, Gunnar Johansson, Florian S. Gutzwiller, Karen Mezzi, Linda Mindeholm, Bine Kjoeller Bjerregaard, Leif Jorgensen, Kjell Larsson
European Respiratory Journal Feb 2021, 57 (2) 2000515; DOI: 10.1183/13993003.00515-2020

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Osteoporosis and fracture risk associated with inhaled corticosteroid use among Swedish COPD patients: the ARCTIC study
Christer Janson, Karin Lisspers, Björn Ställberg, Gunnar Johansson, Florian S. Gutzwiller, Karen Mezzi, Linda Mindeholm, Bine Kjoeller Bjerregaard, Leif Jorgensen, Kjell Larsson
European Respiratory Journal Feb 2021, 57 (2) 2000515; DOI: 10.1183/13993003.00515-2020
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