Abstract

To review the evidence base for the safety of high dose and long-term usage of systemic corticosteroids (CSs). Selection of studies: population-based studies involving patients with polymyalgia rheumatica or vasculitis treated with systemic CSs and reporting the incidence of diabetes, hypertension, cataract, osteoporosis or cardiovascular events. Search strategy: A systematic literature review was conducted in Medline, Medline-in-process, Embase, and the Cochrane Library up to January 2011, with very broad search terms in order to limit the risk of missing relevant studies. Data synthesis: “Key studies” were identified as assessing comparisons relevant to our study question (CSs vs. no use of CSs and/or assessment of CSs at different doses) and reporting at least one outcome of interest by treatment group. Results were summarized separately for key studies and other studies. Out of 3671 citations initially identified for screening 76 publications were selected. Few studies were identified as key: only 3 reported the incidence of diabetes, hypertension or cardio-vascular events, four studies documented the development of cataract and seven reported outcomes related to osteoporosis. Based on these studies, outcomes such as cataract and osteoporosis presented a higher rate of incidence for both indications within the CSs treatment groups, and tended to be less common when the treatment arm combined intravenous or intramuscular CSs with oral CSs than with oral CSs alone. No significant association was found for the other outcomes of interest. The magnitude of the CSs effect on the outcomes of interest varied greatly between studies. Although CSs are a cornerstone of treating polymyalgia rheumatica and vasculitis, the evidence base for their safety profile is poor, subject to a high level of heterogeneity, and the findings for the different outcomes were not always consistent across studies, demonstrating the need for further research in this area.

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