Adverse effects of methylprednisolone pulse therapy in refractory Kawasaki disease.

The efficacy and safety, including arrhythmia and sudden death, 2 of intravenous methylprednisolone pulse (IVMP) therapy in patients with Kawasaki disease (KD) are uncertain. We conducted a control study in KD patients with persistent or recurrent fever (>37.5̊ C) 48 hours after a single infusion of initial intravenous immunoglobulin (IVIG) 2 g/kg. At enrolment (day 1), the subjects were randomised to receive IVMP (30 mg/kg/day of methylprednisolone for three days), or additional IVIG (2 g/kg). Heparin was also continuously infused (15–20 units/kg/h) in the IVMP group. The study was halted prematurely because of adverse effects of IVMP when 22 patients were recruited; they accounted for 13% of KD patients treated with initial IVIG. The antipyretic effect of IVMP was superior to that of additional IVIG on day 2 (p=0.02, repeated measures analysis), but not on day 3 and later (fig 1). The fraction of febrile patients was significantly lower in the IVMP group until day 3 (1/11 v 8/11, p , 0.001, Fisher exact test), but not on day 4 and later (6/11 v 6/11). Coronary artery dimensions and the prevalence of coronary artery lesions (2/11 v 3/11) were similar in the two groups. Regarding adverse effects, sinus bradycardia and hyperglycaemia occurred more often in the IVMP group (table 1). Hypertension occurred in 91% of the IVMP group, but the fraction did not differ significantly, probably due to the small sample size. All of the adverse effects were transient. There were no convulsions, gastrointestinal symptoms, infection, malignant arrhythmia, or sudden death in any subjects. KD patients refractory to initial IVIG should be treated with additional IVIG, 4 because IVMP induced faster but temporary resolution of fever and more adverse effects. Further investigations with steroid therapy are necessary to determine the indication and the appropriate dose in KD.