Brahmajee K. Nallamothu, MD, MPH Short-Term Use of Oral Corticosteroids and Related Harms Among Adults in the United States Akbar K. Waljee, MD, MS Mary A. M. Rogers, PhD, MS Paul Lin, MS Amit G. Singal, MD Joshua D. Stein, MD, MS Rory M. Marks, MB, BS John Z. Ayanian, MD, MPP Brahmajee K. Nallamothu, MD, MPH

Corticosteroids are powerful anti-inflammatory drugs. They have been used for decades. Long-term use has been associated with adverse effects but there are fewer studies regarding low-dose short-term use.

The purpose of this study was to characterize contemporary outpatient utilization of short-term oral corticosteroids and to examine the risk of acute adverse events.

Clinformatics Data Mart 14+ years of data for over 61 million unique members, all with both medical and pharmacy benefits. Between 12.4 and 14 million unique members each year.

We identified all individuals, ages 18 to 64 years, who were continuously enrolled between January 1, 2012 and December 31, 2014. Our primary exposure of interest was an outpatient prescription for an oral formulation of corticosteroids for less than 30 days in duration.

Pharmacy files

Medical files

We answered several questions: How often are low-dose short term corticosteroids used? Among 1,548,945 adults in the study, 21.1% received at least one outpatient prescription in the 3-year period.

What were the characteristics of the users?

What was the indication for treatment? Who prescribed the corticosteroids? Diagnosis codes were grouped using Clinical Classification Software obtained from the Agency for Healthcare Research and Quality.

Are there adverse events associated with use? Hospitalization for sepsis Venous thromboembolism Fracture

How to assess adverse events? Compare users to nonusers.

Adverse Events within 5 to 90 days after a Clinic Visit Corticosteroid Users Nonusers Hospitalization for sepsis 0.05% 0.02% Venous thromboembolism 0.14% 0.09% Fracture 0.51% 0.39%

How to assess adverse events? Compare a person to him/herself.

How to assess adverse events? Compare a person to him/herself. Self controlled case series.

Incidence Rate Ratios

Incidence Rate Ratios

CONCLUSIONS Over a 3-year period, approximately 1 in 5 American adults in a commercially-insured plan used oral corticosteroids for a duration of less than 30 days. The short-term use of these drugs was associated with increased rates of sepsis, venous thromboembolism, and fracture – even at relatively low doses.

Thank you. maryroge@umich.edu