TY - JOUR
T1 - Cumulative Burden of Oral Corticosteroid Adverse Effects and the Economic Implications of Corticosteroid Use in Patients With Systemic Lupus Erythematosus
AU - Shah, Manan
AU - Chaudhari, Sham
AU - McLaughlin, Trent P.
AU - Kan, Hong J.
AU - Bechtel, Benno
AU - Dennis, Gregory J.
AU - Molta, Charles T.
N1 - Funding Information:
GlaxoSmithKline and Human Genome Sciences funded the conduct of this study. Dr. Kan, Mr. Bechtel, and Dr. Molta report being employed by GlaxoSmithKline. Mr. Bechtel and Dr. Molta also report owning stock in GlaxoSmithKline. Dr. Dennis is employed by and owns stock in Human Genome Sciences. Dr. Shah and Mr. Chaudhari are employed by Xcenda, and Xcenda received funding from GlaxoSmithKline. Dr. McLaughlin was employed with Xcenda at the time this study was conducted. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/4
Y1 - 2013/4
N2 - Background: Corticosteroids (CSs) are used to treat patients with systemic lupus erythematosus (SLE) and are associated with potential adverse events (AEs). However, few data are currently available on the risk of AEs in CS users in an SLE population. Objective: To examine AEs related to CS use and costs of treating CS-related AEs in patients with SLE. Methods: In a retrospective cohort study using claims data (study period: January 1, 2000-June 30, 2010), patients aged <18 years having <2 SLE-related (International Classification of Diseases, Ninth Revision, Clinical Modification code 710.0x) outpatient or <1 inpatient/emergency department claim were identified with an index diagnosis date deemed as the date of first SLE diagnosis. Receipt of CS therapy was assessed within 6 months of the index diagnosis date. Cox models were used to evaluate risk of AEs in CS users and nonusers. Associated costs were computed for AEs where risk was significantly different among the cohorts. Results: Of 2717 patients with SLE, 989 received CSs and 1728 did not. Users of CSs were ~1.5 times more likely to develop chronic AEs (sleep disturbances, migraines, cataracts, hypertension, and type 2 diabetes mellitus) and ~2 times more likely to develop acute AEs (pneumonia, herpes zoster, fungal infections, and nausea/vomiting) compared with CS nonusers. The mean annual cost for managing AEs was $4607 and was highest for diabetes mellitus ($9764), hypertension ($8773), and sleep disturbances ($5599). Applying differences in 1-year event rates (CS user: 58.1%; CS nonuser: 75.1%) to cost estimates yielded an additional $784 per year per CS user to manage known CS-related AEs compared with CS nonusers. Conclusions: Although CSs are prescribed to control SLE symptoms, these results highlight potential risks and costs associated with their use, which providers/payers should consider when making treatment decisions.
AB - Background: Corticosteroids (CSs) are used to treat patients with systemic lupus erythematosus (SLE) and are associated with potential adverse events (AEs). However, few data are currently available on the risk of AEs in CS users in an SLE population. Objective: To examine AEs related to CS use and costs of treating CS-related AEs in patients with SLE. Methods: In a retrospective cohort study using claims data (study period: January 1, 2000-June 30, 2010), patients aged <18 years having <2 SLE-related (International Classification of Diseases, Ninth Revision, Clinical Modification code 710.0x) outpatient or <1 inpatient/emergency department claim were identified with an index diagnosis date deemed as the date of first SLE diagnosis. Receipt of CS therapy was assessed within 6 months of the index diagnosis date. Cox models were used to evaluate risk of AEs in CS users and nonusers. Associated costs were computed for AEs where risk was significantly different among the cohorts. Results: Of 2717 patients with SLE, 989 received CSs and 1728 did not. Users of CSs were ~1.5 times more likely to develop chronic AEs (sleep disturbances, migraines, cataracts, hypertension, and type 2 diabetes mellitus) and ~2 times more likely to develop acute AEs (pneumonia, herpes zoster, fungal infections, and nausea/vomiting) compared with CS nonusers. The mean annual cost for managing AEs was $4607 and was highest for diabetes mellitus ($9764), hypertension ($8773), and sleep disturbances ($5599). Applying differences in 1-year event rates (CS user: 58.1%; CS nonuser: 75.1%) to cost estimates yielded an additional $784 per year per CS user to manage known CS-related AEs compared with CS nonusers. Conclusions: Although CSs are prescribed to control SLE symptoms, these results highlight potential risks and costs associated with their use, which providers/payers should consider when making treatment decisions.
KW - Adverse events
KW - Corticosteroids
KW - Costs
KW - Systemic lupus erythematosus
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U2 - 10.1016/j.clinthera.2013.03.001
DO - 10.1016/j.clinthera.2013.03.001
M3 - Article
C2 - 23587268
AN - SCOPUS:84876321869
SN - 0149-2918
VL - 35
SP - 486
EP - 497
JO - Clinical therapeutics
JF - Clinical therapeutics
IS - 4
ER -