Coronary disease & ACSRandomised controlled trial
Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease
- Randomised controlled trial
- multicentre
- open-label
Authors' conclusion
The addition of prednisolone to standard primary treatment for Kawasaki disease did not reduce the incidence of coronary-artery lesions at 1 month after illness onset.
Study context
- Population
- Participants with newly diagnosed Kawasaki disease, China
- Participants
- 3,208 participants
- Comparison
- Prednisolone plus standard treatment vs standard treatment alone
- Primary endpoint
- Coronary-artery lesions
- Follow-up
- 1 month after illness onset
Primary result
As reported in the abstract
Adjusted risk difference
1.1 percentage points
95% CI −1.0 to 3.4
P = 0.31
By group
Secondary outcomes
Rescue therapy · not controlled for multiplicity
Coronary-artery lesions · 3 months
Progression of coronary-artery lesions · 3 months
Medium-to-giant coronary-artery aneurysms · 3 months
Duration of fever · not controlled for multiplicity
Reduction in CRP level · 72 hours · not controlled for multiplicity
Coronary-artery z scores
- Decreases in coronary-artery z scores were similar in the two groups
Safety
Overall adverse events
- Overall incidence of adverse events did not differ significantly between the two groups
Original publication
Summarised from the published abstract; every number is checked against it