Recruitment discontinued because of serious adverse events after randomization of 262 patients
TUESDAY, Aug. 1, 2017 (HealthDay News) — Oral methylprednisolone is associated with increased risk of serious adverse events among patients with immunoglobulin A (IgA) nephropathy and proteinuria of greater than 1 g/day, according to a study published in the Aug. 1 issue of the Journal of the American Medical Association.
Jicheng Lv, M.D., from the Peking University First Hospital in Beijing, and colleagues randomized patients with IgA nephropathy (proteinuria >1 g/day and estimated glomerular filtration rate of 20 to 120 mL/min/1.73 m²) to oral methylprednisolone (136 patients) or matching placebo (126 patients) for two months, with subsequent weaning over four to six months.
Recruitment was discontinued because of excess serious adverse events after randomization of 262 participants. The researchers found that serious events occurred in 14.7 and 3.2 percent of participants in the methylprednisolone and placebo groups, respectively, mainly due to excess serious infections (8.1 versus 0 percent), including two deaths. The primary renal outcome of end-stage kidney disease, death due to kidney failure, or a 40 percent decrease in estimated glomerular filtration rate occurred in 5.9 percent of the methylprednisolone group and 15.9 percent of the placebo group (hazard ratio, 0.37).
“Although the results were consistent with potential renal benefit, definitive conclusions about treatment benefit cannot be made, owing to early termination of the trial,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.
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