Adverse events of intravenous glucocorticoid pulse therapy in inflammatory diseases: a meta-analysis.

OBJECTIVES To systematically analyse the literature on reported adverse events (AEs) of intravenous pulse glucocorticoids (GCs) (≥ 250 mg prednisone equivalent) for inflammatory diseases. METHODS A literature search was done using PubMed, Embase, and Cochrane databases. Studies were selected by two reviewers (NAMS and ND). Available data on the prevalence of GC-related AEs in patients with inflammatory diseases were retrieved. RESULTS In only 8 studies (344 patients), 4 placebo-controlled and 4 not placebo-controlled studies, intravenous pulse GC-related AEs had been documented (in total 323 AEs), with an AE rate of 35/100 patient-years. In the 4 placebo-controlled studies among RA and systemic sclerosis patients, most of the odds ratios of individual AEs were not statistically significant, except for flushing, heart rhythm disorder, disturbance of taste, lower respiratory infection, and headache. In the 4 not placebo-controlled studies increased diastolic blood pressure was most frequent, followed by flushing and diabetes mellitus. Adverse events seen in more than 15% of patients of all included studies were increased blood pressure, flushing, headache, disturbance of taste, tachycardia and hyperglycemia. CONCLUSIONS GC pulse therapy results in a high AE rate, i.e. 35/100 patient-years. Cardiovascular AEs are most frequently reported in the literature. Furthermore, flushing had the highest odds ratio in the placebo-controlled studies and also a high event rate in the not placebo-controlled studies.