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Abstract Number: 1823

Short Periods of Glucocorticoid Use Increase the Risk of Gastrointestinal Bleeding

Steven C. Vlad1, David T. Felson2, Donald R. Miller3 and Yuqing Zhang4, 1Clinical Epidemiology, Boston University, Boston, MA, 2Boston University, Boston, MA, 3Center for Health Quality, Outcomes, and Economic Research, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, 4Clinical Epidemiology Unit, Boston University, Boston, MA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: Gastrointestinal complications and glucocorticoids

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Session Information

Session Title: Epidemiology and Health Services Research: Rheumatic Disease Pharmacoepidemiology

Session Type: Abstract Submissions (ACR)

Background/Purpose: Short term use of glucocorticoids (GCs) is thought to be relatively benign and most adverse events have been studied in chronic users; there is little if any published evidence about the safety of short term use.  We aimed to examine whether short periods of GC use are associate with an elevated risk of gastrointestinal bleeding (GIB).

Methods: We used national US Veterans Administration data from fiscal year 1998 through 2008 to compare the risk for GIB during periods of GC use compared to periods of non-use using a self-controlled case series design. This is a case-only design which compares risks within persons, thus limiting confounding. Based on prescription records we first developed a cohort of subjects who had only used ‘burst’ GCs, defined as dispensed oral prescriptions of ² 30 days with at least 42 days between consecutive prescriptions. We excluded persons who received GCs during their first 60 days of follow-up or who could have received GCs during a prior hospitalization so as to limit the amount of unmeasured GC use.  From these subjects, we selected those who had a first GIB requiring hospitalization using previously validated ICD-9 codes; we excluded cases who had a GIB within the first year of follow-up (to limit the number with possible recurrences) and those using NSAIDs during the follow-up period so as to eliminate this as a potential confounder. We focused on the period in which each subject was using GCs, as well as 30 days before and after to account for confounding by indication and any residual GC effects.  The risk of GIB in each of these periods was compared to that in the remaining period of follow-up time.  We controlled for age in 5 year bands (18-24, 25-29, 30-34, … , > 80).

Results: There were 433 cases of GIB among burst GC users. 94.7% were men. Mean age at GIB was 65.2 (sd 11.9) years; 65.9 (11.5) in men, 53.6 (12.4) in women. 71.4% of subjects were white, 13.7% African American, 6.3% Hispanic, 8.6% other. All cases had only 1 GC prescription for a median duration of 8 (Q1, Q3: 1, 14) days and median average daily prednisone equivalent dose of 20 (17.5, 26.8) mg.  The incidence rate ratio (IRR) of GIB while using GCs was 5 times that of the baseline risk period. See table.

No. cases of GIB in risk period

Incidence rate ratio

95% CI

Total number of cases

433

Reference period (no GC use)

406

1.0

–

1-30 days prior to GC prescription

11

2.0

1.1, 3.7

Time while GC was being used

8

5.1

2.5, 10.4

1-30 days after GC discontinuation

8

1.5

0.7, 3.0

Conclusion: Our results suggest that even short periods of GC use increase the risk of GI bleeding and that the risk corresponds to the time when the drug is being used.


Disclosure:

S. C. Vlad,
None;

D. T. Felson,
None;

D. R. Miller,
None;

Y. Zhang,
None.

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