PMID- 27378247
OWN - NLM
STAT- MEDLINE
DCOM- 20170901
LR  - 20220316
IS  - 1532-866X (Electronic)
IS  - 0049-0172 (Linking)
VI  - 46
IP  - 2
DP  - 2016 Oct
TI  - Corticosteroid-related adverse events in patients with giant cell arteritis: A 
      claims-based analysis.
PG  - 246-252
LID - S0049-0172(16)30061-0 [pii]
LID - 10.1016/j.semarthrit.2016.05.009 [doi]
AB  - OBJECTIVE: Corticosteroids (CS) are standard treatment for giant cell arteritis 
      (GCA), but concerns persist over toxicities associated with long-term use. In 
      this retrospective study of medical claims data, we estimated risks for adverse 
      events (AEs) in CS-treated GCA patients. METHODS: Cox regression analyses with CS 
      use as a time-dependent variable were conducted on data from the 2003 to 2012 
      Truven Health Analytics MarketScan Database. Patients 50 years of age and older 
      who had >/=2 claims of newly diagnosed GCA, >/=1 filled oral CS prescription, and no 
      AEs before GCA diagnosis were included. The primary outcome was presence of a new 
      CS-related AE. RESULTS: In total, 2497 patients were included. Their mean age was 
      71.0 years, and 71% were women. Follow-up was 9680 patient-years (PY). CS 
      treatment continued for a mean (SD) of 1.196 (729.2) days; mean (SD) prescribed 
      cumulative CS dose was 6983.3mg (6519.9). The overall AE rate was 0.43 events/PY; 
      the most frequent AEs were cataract and bone disease. For each 1000-mg increase 
      in CS exposure, the hazard ratio (HR) increased by 3% (HR = 1.03; 95% CI: 
      1.02-1.05; P < 0.001). Additionally, statistically significant individual 
      associations between increased CS exposure and AE risk were observed for 
      bone-related AEs (P < 0.001), cataract (P < 0.001), glaucoma (P = 0.005), 
      pneumonia (P = 0.003), and diabetes mellitus (P < 0.001 in a subset of patients 
      with no previous history of diabetes). CONCLUSION: CS exposure significantly 
      increased risk for potentially serious AEs, emphasizing a need for new treatment 
      options for GCA patients.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Broder, Michael S
AU  - Broder MS
AD  - Partnership for Health Analytic Research, LLC, Beverly Hills, CA.
FAU - Sarsour, Khaled
AU  - Sarsour K
AD  - Real World Data Science/Global Product Development, Genentech, 1 DNA Way, South 
      San Francisco, CA 94080-4990. Electronic address: sarsourk@gene.com.
FAU - Chang, Eunice
AU  - Chang E
AD  - Partnership for Health Analytic Research, LLC, Beverly Hills, CA.
FAU - Collinson, Neil
AU  - Collinson N
AD  - Roche Products Ltd., Welwyn Garden City, UK.
FAU - Tuckwell, Katie
AU  - Tuckwell K
AD  - Roche Products Ltd., Welwyn Garden City, UK.
FAU - Napalkov, Pavel
AU  - Napalkov P
AD  - Real World Data Science/Global Product Development, Genentech, 1 DNA Way, South 
      San Francisco, CA 94080-4990.
FAU - Klearman, Micki
AU  - Klearman M
AD  - Real World Data Science/Global Product Development, Genentech, 1 DNA Way, South 
      San Francisco, CA 94080-4990.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160602
PL  - United States
TA  - Semin Arthritis Rheum
JT  - Seminars in arthritis and rheumatism
JID - 1306053
RN  - 0 (Adrenal Cortex Hormones)
SB  - IM
MH  - Adrenal Cortex Hormones/*adverse effects/therapeutic use
MH  - Aged
MH  - Bone Diseases/*chemically induced
MH  - Cataract/*chemically induced
MH  - Databases, Factual
MH  - Female
MH  - Giant Cell Arteritis/*drug therapy
MH  - Humans
MH  - Male
MH  - Risk Assessment
OTO - NOTNLM
OT  - Adverse events
OT  - Corticosteroids
OT  - Epidemiology
OT  - Giant cell arteritis
OT  - Health care insurance claims
EDAT- 2016/07/06 06:00
MHDA- 2017/09/02 06:00
CRDT- 2016/07/06 06:00
PHST- 2016/02/09 00:00 [received]
PHST- 2016/05/16 00:00 [revised]
PHST- 2016/05/27 00:00 [accepted]
PHST- 2016/07/06 06:00 [entrez]
PHST- 2016/07/06 06:00 [pubmed]
PHST- 2017/09/02 06:00 [medline]
AID - S0049-0172(16)30061-0 [pii]
AID - 10.1016/j.semarthrit.2016.05.009 [doi]
PST - ppublish
SO  - Semin Arthritis Rheum. 2016 Oct;46(2):246-252. doi: 
      10.1016/j.semarthrit.2016.05.009. Epub 2016 Jun 2.