PMID- 8109596
OWN - NLM
STAT- MEDLINE
DCOM- 19940324
LR  - 20220409
IS  - 0002-9343 (Print)
IS  - 0002-9343 (Linking)
VI  - 96
IP  - 2
DP  - 1994 Feb
TI  - Low dose long-term corticosteroid therapy in rheumatoid arthritis: an analysis of 
      serious adverse events.
PG  - 115-23
AB  - 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.
FAU - Saag, K G
AU  - Saag KG
AD  - Department of Internal Medicine, University of Iowa, Iowa City.
FAU - Koehnke, R
AU  - Koehnke R
FAU - Caldwell, J R
AU  - Caldwell JR
FAU - Brasington, R
AU  - Brasington R
FAU - Burmeister, L F
AU  - Burmeister LF
FAU - Zimmerman, B
AU  - Zimmerman B
FAU - Kohler, J A
AU  - Kohler JA
FAU - Furst, D E
AU  - Furst DE
LA  - eng
GR  - RR-59/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Am J Med
JT  - The American journal of medicine
JID - 0267200
RN  - 0 (Anti-Inflammatory Agents)
RN  - VB0R961HZT (Prednisone)
SB  - IM
CIN - Am J Med. 1995 Dec;99(6):692-4. PMID: 7503098
MH  - Adult
MH  - Anti-Inflammatory Agents/administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Prednisone/administration & dosage/*adverse effects
MH  - Retrospective Studies
MH  - Time Factors
EDAT- 1994/02/01 00:00
MHDA- 1994/02/01 00:01
CRDT- 1994/02/01 00:00
PHST- 1994/02/01 00:00 [pubmed]
PHST- 1994/02/01 00:01 [medline]
PHST- 1994/02/01 00:00 [entrez]
AID - 0002-9343(94)90131-7 [pii]
AID - 10.1016/0002-9343(94)90131-7 [doi]
PST - ppublish
SO  - Am J Med. 1994 Feb;96(2):115-23. doi: 10.1016/0002-9343(94)90131-7.