RESEARCH - Low dose long-term steroid therapy in RA: an analysis of serious adverse events

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Am J Med. 1994 Feb;96(2):115-23.

Low dose long-term corticosteroid therapy in rheumatoid arthritis: an

analysis of serious adverse events.

Saag KG, Koehnke R, Caldwell JR, Brasington R, Burmeister LF, Zimmerman B,

Kohler JA, Furst DE.

Department of Internal Medicine, University of Iowa, Iowa City.

PURPOSE: The purpose of this study was to better define the toxicity of low

dose (less than or equal to 15 mg/d prednisone or equivalent) long-term

(greater than 1 year) corticosteroids in the treatment of rheumatoid

arthritis (RA). PATIENTS AND METHODS: We examined an historical cohort of

112 RA patients on low dose (6.1 +/- 3.1 mg/d, mean +/- SD) long-term (6.2

+/- 4.6 years) prednisone (CS) and compared them to 112 matched RA patients

not using prednisone (CO). CS were matched one-to-one with CO for sex (75%

women), age (+/- 5 yrs), race (98% white), and duration of disease (+/- 5

yrs). Subjects were determined by review of unselected medical records from

three distinct rheumatology practice settings. For CS, charts were

abstracted from the date of prednisone start for predefined adverse events

(AEs). RESULTS: Ninety-two (92) AEs were noted in CS versus 31 in CO and

included: fracture (CS:21 versus CO:8), serious infections (CS:14 versus

CO:4), gastrointestinal (GI) bleed or ulcer (CS:11 versus CO:4), and

cataracts (CS:17 versus CO:5). At time of first AE, CS prednisone average

dose was 7.0 +/- 2.6 mg with a duration of 4.9 +/- 3.9 years. Stepwise

multiple logistic regression analysis was used to create a model which

included all clinically relevant variables and all parameters significantly

different at the cohort inception. Prednisone average dose of greater than

10 to less than or equal to 15 mg/d correlated most strongly with the

development of an AE (Odds Ratio (OR) = 32.3, 95% Confidence Interval (CI)

4.6, 220). Average prednisone 5 to 10 mg (OR = 4.5, 95% CI 2.1, 9.6), RA

nodules (OR = 3.9, 95% CI 1.9, 8.0), and bony erosions (OR = 2.4, 95% CI

1.2, 4.7) also entered the final model. Kaplan Meier survival curves for the

development of the first AE showed a dose-response relationship between

prednisone and AE occurrence, independent of rheumatoid nodules. Subset

analyses utilized a nested case control design for the development of three

serious AEs: fractures, serious infections, and GI events. These analyses

revealed possible relationships between prednisone use and the development

of each specific AE (prednisone use OR: fracture 3.9, 95% CI 0.8, 18.1;

infection 8.0, 95% CI 1.0, 64.0; and GI event 3.3, 95% CI 0.9, 12.1).

CONCLUSIONS: Although disease severity is an important confounding factor,

low dose long-term prednisone use equal to or greater than 5 mg/d is

correlated with the development of specific adverse events in a

dose-dependent fashion.

PMID: 8109596

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve & db=pubmed & list_uids=8\

109596 & dopt=Abstract

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