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