1. Patients experienced a greater incidence of severe adverse events during the 3-month period following prescription of a steroid burst compared to the 3-month period prior.
2. During the posttreatment period, the risk for severe adverse events generally appeared to decrease over time but nonetheless remained elevated above baseline.
Evidence Rating Level: 2 (Good)
Study Rundown: Long-term use of oral corticosteroids is associated with numerous adverse events across multiple organ systems. As such, steroid bursts, defined as courses lasting fewer than two weeks, are more commonly prescribed in the treatment of inflammatory diseases, but data are scarce regarding whether this strategy effectively mitigates the risks associated with steroid use. This population-based study examined the relationship between steroid bursts and 3 specific severe adverse events: GI bleeding, sepsis, and heart failure. Data was collected from different time frames before and after each participant was prescribed a steroid burst, and analysis using self-control revealed higher incidences of all three adverse events in the posttreatment period compared to the pretreatment reference period, with the greatest rate difference being observed in GI bleeding. The risk of each event was greatest during the first month after initiating treatment and was attenuated in the following two months, although still significantly higher than the respective risks during the reference period. The retrospective nature of this study limited analysis of factors such as lifestyle factors and medication compliance. Further, the exclusion of certain vulnerable populations resulted in decreased generalizability and a potential underestimation of the true incidence rate of adverse events. Further research should be done regarding optimal dosing of corticosteroids in order to maintain therapeutic effect yet maximize patient safety.
In-Depth [case series]: In this self-controlled case series, the Taiwanese National Health Insurance Research Database was sifted for the medical claims records of 2,623,327 adults aged 20 to 64 years who had continuous enrollment in the program from 2012-2015 and received a prescription for a single steroid burst at some point during the latter three years of this period. Patients were excluded if they had previously received topical or systemic corticosteroids or been diagnosed with any of the three severe adverse events being investigated. During the two posttreatment periods (5 to 30 and 31 to 90 days after initiation of treatment), the overall incidence rates per 1000 person-years were 27.1 (95% confidence interval [CI], 26.7 to 27.5) for GI bleeding, 1.5 (CI, 1.4 to 1.6) for sepsis, and 1.3 (CI, 1.2 to 1.4) for heart failure. Compared to the reference period (5 to 90 days before initiation), the rate differences were 10.3 (CI, 9.9 to 10.7) for GI bleeding, 0.1 (CI, 0.01 to 0.2) for sepsis, and 1.0 (CI, 0.9 to 1.1) for heart failure. All incidence rate ratios (IRRs) were highest during the first posttreatment periodⷨ but decreased during the second—1.80 (CI, 1.75 to 1.84) vs 1.17 (CI, 1.14 to 1.19) for GI bleeding, 1.99 (CI, 1.70 to 2.32) vs 1.51 (1.33 to 1.72) for sepsis, and 2.37 (CI, 2.13 to 2.63) vs 1.35 (1.24−1.47) for heart failure. In sensitivity analyses, the confidence intervals of the E-values for each condition were greater than and did not overlap with the intervals of the respective IRRs, confirming that the observed effect was robust to potential unmeasured confounders. Further, the incidence of syncope, the negative control, was not affected by steroid use.
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