Common steroid for kidney disease linked to infection risk

By Australian Hospital + Healthcare Bulletin Staff
Friday, 04 August, 2017

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A steroid treatment for a common kidney condition has been linked to serious side effects.

The risk was uncovered by an Australian and Chinese drug trial into the steroid, which was halted as a result.

The steroid methylprednisolone, a drug on the WHO’s List of Essential Medicines, is prescribed for people with IgA nephropathy — a condition that causes kidney inflammation — who have protein in their urine. The trial was examining the drug, which has not been studied in depth, but was discontinued because of an unexpectedly high rate of serious infections.

Up to 30% of people with IgA nephropathy will eventually develop end-stage kidney disease; decreased kidney function, persistent proteinuria and hypertension are the strongest risk factors. Guidelines recommend corticosteroids in patients with IgA nephropathy and persistent proteinuria, and they are widely used in these patients, but the benefits and risks have not been clearly established.

Researchers randomly assigned study participants with IgA nephropathy and proteinuria to oral methylprednisolone (n = 136) or a placebo (n = 126) for two months, with subsequent weaning over four to six months. The results of the study were published in JAMA,

After 2.1 years’ median follow-up, recruitment was discontinued because of an unexpectedly high rate of serious adverse events (including infections as well as gastrointestinal and bone disorders). Serious events occurred in 20 participants (14.7%) in the methylprednisolone group vs four (3.2%) in the placebo group, mostly due to excess serious infections (8.1% vs zero), including two deaths. The primary renal outcome — end-stage kidney disease, death due to kidney failure or a 40% decrease in estimated glomerular filtration rate (a measure of substantial loss of kidney function) — occurred in eight participants (5.9%) in the methylprednisolone group vs 20 (15.9%) in the placebo group.

“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 wrote.

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