Safety of glucocorticoids - clinical trials.

Clinical trials published over the last 5 years support the main conclusion of a comprehensive review on glucocorticoid safety published in 2006: there is little if any solid evidence to support the fear that low-dose glucocorticoids are associated with significant toxicity when used appropriately in inflammatory rheumatic diseases. In fact, most of the recent randomised-controlled research underlines the influence of the underlying inflammatory process in the occurrence of 'adverse events' such as osteoporosis, fractures, hypertension and glucose intolerance. This 'confounding by indication' is inherent to the field and questions the validity of the observational data, that seems to drive currently common concepts about low-dose glucocorticoid toxicity. Decisive conclusions cannot, in any case, be achieved at this stage because the clinical trials available are of limited duration and dimension and have not been designed specifically to address toxicity. Toxicity with low-dose glucocorticoids needs to be kept under careful clinical surveillance while we expect such trials to be produced. Meanwhile, the risks of stopping these medications, even on longstanding well controlled disease, need also to be considered, as underlined by withdrawal trials recently published.