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Extended study with a lower dose of steroids reports overall benefit for adults with IgA nephropathy
Clinical Question
Is a lower dose of corticosteroids an effective and safe treatment for adults with IgA nephropathy and persistent proteinuria?
Bottom line
The first phase of this trial was prematurely terminated due to an excess of serious infections in the steroid group. In the extended phase, which is reported here, the investigators reduced the dose of oral methylprednisolone and added antibiotic prophylaxis for pneumocystis pneumonia. Similar beneficial reductions in adverse renal events occurred with the reduced-dose and original full-dose regimens, but serious adverse events occurred significantly less often with the reduced-dose regimen. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
The original TESTING trial enrolled 503 adults with biopsy-proven primary IgA nephropathy, an estimated glomerular filtration rate (eGFR) between 20 and 120 mL/min/1.73 m2, and urinary protein excretion greater than 1 g per day. After 262 participants were randomized, an excess of serious infections was identified. In this extended arm of the trial, investigators reduced the dose of oral methylprednisolone (from 0.6 to 0.8 mg/kg/d [maximum dose 48 mg/d] to 0.4 mg/kg/d [maximum dose 32 mg/d]) in the remaining 241 participants. In addition, all participants received standard antibiotic prophylaxis for pneumocystis pneumonia for the first 12 weeks of the treatment period. Complete follow-up occurred for a total of 493 patients (98%), for a mean of 4.2 years. Using intention-to-treat analysis and continuing the original randomized protocol compared with a placebo control group, the primary outcome of all bad renal outcomes (40% decline in eGFR, kidney failure requiring dialysis or transplant, or death due to kidney disease) occurred significantly less frequently in the steroid group than in the placebo group (number needed to treat = 7; 95% CI 4.5 - 16.9), with no significant difference in benefit in the reduced-dose versus original full-dose regimen compared with placebo. Most important, serious adverse events occurred significantly less often in patients taking the reduced dose (6 in the reduced-dose group [vs 3 in the placebo group] vs 22 in the full-dose group [vs 4 in the placebo group]).
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
no
no
I will check the dose which…
I will check the dose which my patient is taking.
IgA nephropathy and methylprednisolone
Interesting study. It serves as an excellent reminder of the important side effects of high dose steroids (presumably used for any condition). Very encouraging though to learn that the lower dose was as clinically effective as the higher dose but with fewer side effects. The NNT for benefit of 7 is superb esp since the outcomes of progressive nephropathy are extremely significant.
low dose steroids
improve outcome of IgA nephropathy