Childhood nephrotic syndrome: extending prednisolone to 16 weeks offers no benefit

  • BMJ

  • International Clinical Digest
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • In children having a first episode of steroid-sensitive nephrotic syndrome, extending prednisolone treatment from 8 to 16 weeks offers no clinical benefit, according to  this phase 3 trial .
  • Short-term economic benefit was seen, attributable to reduced resource use. 

Why this matters

  • Although most countries stick to 8-week course, some trials and reviews had suggested potential clinical benefits with a longer duration.

Key results

  • Time to first relapse did not differ between having an 8-week vs a 16-week course:
    • HR, 0.87 (95% CI, 0.65-1.17).
  • Incidence of frequently relapsing nephrotic syndrome also did not change:
    • Extended 60/114 (53%) vs standard course 55/109 (50%; P=.75).
  • Extending duration did not reduce the need for other immunosuppressive treatment.
  • Serious adverse event rate did not differ between course durations, with the exception of worse behavior with the 8-week course.
  • QoL improvement was seen with 16 vs 8 weeks of treatment, and costs decreased.

Study design

  • Double-blind, phase 3 randomized, placebo-controlled trial involving 237 children aged 1-14 years at 125 UK general hospitals/tertiary care centers, with cost-effectiveness analysis.
  • Primary outcome: time to first relapse (in minimum 24 months).
  • Funding: UK National Institute for Health Research.

Limitations

  • Children who could not tolerate a crushed tablet not included.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit