Quantitative characterization of the relationship between levels of extended corticosteroid use and related adverse events in a US population

Rice JB1, White AG1, Johnson M1, Wagh A1, Qin Y2, Bartels-Peculis L2, Ciepielewska G2, Nelson WW2.
Curr Med Res Opin. 2018 May 9:1-18. doi: 10.1080/03007995.2018.1474090. [Epub ahead of print]

Abstract
OBJECTIVE:
This retrospective study assessed the incidence and timing of adverse events (AEs) among patients prescribed varying dose levels of corticosteroids in the US.

METHODS:
Patients with selected autoimmune or inflammatory disease diagnoses between 2006 and 2015 were identified from a privately-insured administrative database. Patients were stratified into treatment cohorts based on dosage and length of corticosteroid use: intermittent use with duration <60 days, and three extended use cohorts with duration ≥60 days at low (≤7.5 mg/day), medium (>7.5-≤15 mg/day), or high (>15 mg/day) prednisone-equivalent dosage. The incidence of and time to corticosteroid-related AEs were assessed by cohort.

RESULTS:
78,704 patients met the selection criteria, of whom 9.5%, 11.0%, and 8.6% were classified into the high-, medium-, and low-dose extended corticosteroid use cohorts, respectively. Corticosteroid exposure varied across study conditions, from 34% of dermatomyositis/polymyositis to 6% of psoriatic arthritis patients prescribed extended high-dose. Hypertension, pneumonia, and osteoporosis were AEs with the highest incidence rates (41.9, 27.4, and 19.8 cases per 1,000 patient-months for high-dose cohort, respectively). For most AEs, all levels of extended corticosteroid use exhibited significant risks of increased incidence compared to intermittent use. Some AEs had dose-relationships, with higher dose correlated with higher incidence; other AEs had duration-relationships with longer duration correlated with higher incidence regardless of dose. Average time to AE onset was relatively short, occurring at 2.3-6.7 months after corticosteroid initiation.

CONCLUSIONS:
Through a rigorous quantitative characterization, extended steroid exposure was associated with increased incidence and earlier onset of AEs among privately-insured adults in the US.

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