Adverse events of low-to-medium-dose oral glucocorticoids in inflammatory diseases: A meta-analysis

Abstract

Objectives: To systematically analyze the literature on reported adverse events of low to medium dose glucocorticoids during ≥1 month for inflammatory diseases.

Methods: Data were systematically retrieved and selected from PUBMED, EMBASE, and CINAHL databases (6097 hits).

Results: In total, 28 studies (2,382 patients) met the inclusion criteria. The risk of adverse events over all studies together was 150 per 100 patient year (95% confidence interval (CI) 132;169). Psychological & behavioural adverse events (e.g. minor mood disturbances) were most frequently reported, followed by gastro-intestinal (e.g. dyspepsia, dysfagia). In 14 studies comprising 796 patients with rheumatoid arthritis the risk of adverse events was 43/100 patient years (CI 30 ; 55), in 4 studies with 167 patients with polymyalgia rheumatica the risk of adverse events was 80/100 (CI 15;146), and in 10 studies, 1,419 patients, with inflammatory bowel disease the risk of adverse events was 555/100 (CI 391;718). High adverse events rates were reported in high quality studies with short follow-up, notably in inflammatory bowel patient studies.

Conclusions: The risk of adverse events depends on study design and disease. Studies on inflammatory bowel disease were often clinical trials of short duration with frequent documentation of adverse events which resulted in higher adverse events rates, whereas in rheumatoid arthritis studies, the rather long follow-up may have resulted in lower adverse events rates. In most studies, aimed at efficacy of glucocorticoids or other drugs, adverse events were not systematically assessed. Clear guidelines on assessment of adverse events are lacking.