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  2. Short term use of oral...
  3. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study
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Research

Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1415 (Published 12 April 2017) Cite this as: BMJ 2017;357:j1415
  1. Akbar K Waljee, assistant professor1 2 3 4,
  2. Mary A M Rogers, research associate professor2 4 5,
  3. Paul Lin, statistican2,
  4. Amit G Singal, associate professor6,
  5. Joshua D Stein, associate professor2 7 8,
  6. Rory M Marks, associate professor9,
  7. John Z Ayanian, professor2 5 8,
  8. Brahmajee K Nallamothu, professor1 2 4 10
  1. 1VA Center for Clinical Management Research, Ann Arbor, MI, USA
  2. 2University of Michigan Medical School, Institute for Healthcare Policy and Innovation, Ann Arbor, MI, USA
  3. 3University of Michigan Medical School, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Ann Arbor, MI, USA
  4. 4Michigan Integrated Center for Health Analytics and Medical Prediction (MiCHAMP), Ann Arbor, MI, USA
  5. 5University of Michigan Medical School, Department of Internal Medicine, Division of General Medicine, Ann Arbor, MI, USA
  6. 6Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA
  7. 7University of Michigan Medical School, Department of Ophthalmology and Visual Science, Ann Arbor, MI, USA
  8. 8University of Michigan School of Public Health, Department of Health Management and Policy, University of Michigan, Ann Arbor, MI, USA
  9. 9University of Michigan Medical School, Department of Internal Medicine, Division of Rheumatology, Ann Arbor, MI, USA
  10. 10University of Michigan Medical School, Department of Internal Medicine, Division of Cardiovascular Medicine, Ann Arbor, MI, USA
  1. Correspondence to: A K Waljee awaljee{at}med.umich.edu
  • Accepted 14 March 2017

Abstract

Objective To determine the frequency of prescriptions for short term use of oral corticosteroids, and adverse events (sepsis, venous thromboembolism, fractures) associated with their use.

Design Retrospective cohort study and self controlled case series.

Setting Nationwide dataset of private insurance claims.

Participants Adults aged 18 to 64 years who were continuously enrolled from 2012 to 2014.

Main outcome measures Rates of short term use of oral corticosteroids defined as less than 30 days duration. Incidence rates of adverse events in corticosteroid users and non-users. Incidence rate ratios for adverse events within 30 day and 31-90 day risk periods after drug initiation.

Results Of 1 548 945 adults, 327 452 (21.1%) received at least one outpatient prescription for short term use of oral corticosteroids over the three year period. Use was more frequent among older patients, women, and white adults, with significant regional variation (all P<0.001). The most common indications for use were upper respiratory tract infections, spinal conditions, and allergies. Prescriptions were provided by a diverse range of specialties. Within 30 days of drug initiation, there was an increase in rates of sepsis (incidence rate ratio 5.30, 95% confidence interval 3.80 to 7.41), venous thromboembolism (3.33, 2.78 to 3.99), and fracture (1.87, 1.69 to 2.07), which diminished over the subsequent 31-90 days. The increased risk persisted at prednisone equivalent doses of less than 20 mg/day (incidence rate ratio 4.02 for sepsis, 3.61 for venous thromboembolism, and 1.83 for fracture; all P<0.001).

Conclusion One in five American adults in a commercially insured plan were given prescriptions for short term use of oral corticosteroids during a three year period, with an associated increased risk of adverse events.

Footnotes

  • Contributors: AKW and BKN had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. They are the guarantors. AKW and MAMR conceived and designed the study. All authors acquired, analysed, and interpreted the data; critically revised the manuscript; and gave final approval of the manuscript. AKW and BKN drafted the manuscript. AKW, MAMR, and PL were responsible for the figures. The authors are solely responsible for the design, conduct, data analyses, and drafting and editing of the manuscript and its final content. The contents do not represent the views of the US Department of Veterans Affairs or the United States government.

  • Funding: AKW is supported by a career development grant award (CDA 11-217) from the United States Department of Veterans Affairs Health Services Research and Development Service. AKW and BKN are supported by funding from the Michigan Institute for Data Science (MIDAS). JDS is supported by grants from Research to Prevent Blindness and WK Kellogg Foundation. Data acquisition and statistical and administrative support was supported by the Institute for Healthcare Policy and Innovation at the University of Michigan. These funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by the University of Michigan institutional research board.

  • Data sharing: No additional data are available.

  • Transparency: The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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