Extended corticosteroid use can significantly increase the incidence of adverse events compared with intermittent use, according to a new research. Adverse events occurred between 2.3 and 6.7 months after initiation of corticosteroids. Also, dose-relationships and duration-relationships were identified with some adverse events.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered to a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
J.Bradford Rice and his colleagues conducted the retrospective study to assess the incidence and timing of adverse events (AEs) among patients prescribed varying dose levels of corticosteroids.
Patients with selected autoimmune or inflammatory disease were included in the study. 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.
Out of the 78,704 patients, 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.
The study found that hypertension, pneumonia, and osteoporosis were adverse events with the highest incidence rates. 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.
The study concluded that for most adverse events, all levels of corticosteroid use exhibited significant risks of increased incidence compared to intermittent use.
The study was published in the journal Current Medical Research and Opinion.
For more reference log on to https://doi.org/10.1080/03007995.2018.1474090