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Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease.

Publication ,  Journal Article
Newburger, JW; Sleeper, LA; McCrindle, BW; Minich, LL; Gersony, W; Vetter, VL; Atz, AM; Li, JS; Takahashi, M; Baker, AL; Colan, SD; Klein, GL ...
Published in: N Engl J Med
February 15, 2007

BACKGROUND: Treatment of acute Kawasaki disease with intravenous immune globulin and aspirin reduces the risk of coronary-artery abnormalities and systemic inflammation, but despite intravenous immune globulin therapy, coronary-artery abnormalities develop in some children. Studies have suggested that primary corticosteroid therapy might be beneficial and that adverse events are infrequent with short-term use. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to determine whether the addition of intravenous methylprednisolone to conventional primary therapy for Kawasaki disease reduces the risk of coronary-artery abnormalities. Patients with 10 or fewer days of fever were randomly assigned to receive intravenous methylprednisolone, 30 mg per kilogram of body weight (101 patients), or placebo (98 patients). All patients then received conventional therapy with intravenous immune globulin, 2 g per kilogram, as well as aspirin, 80 to 100 mg per kilogram per day until they were afebrile for 48 hours and 3 to 5 mg per kilogram per day thereafter. RESULTS: At week 1 and week 5 after randomization, patients in the two study groups had similar coronary dimensions, expressed as z scores adjusted for body-surface area, absolute dimensions, and changes in dimensions. As compared with patients receiving placebo, patients receiving intravenous methylprednisolone had a somewhat shorter initial period of hospitalization (P=0.05) and, at week 1, a lower erythrocyte sedimentation rate (P=0.02) and a tendency toward a lower C-reactive protein level (P=0.07). However, the two groups had similar numbers of days spent in the hospital, numbers of days of fever, rates of retreatment with intravenous immune globulin, and numbers of adverse events. CONCLUSIONS: Our data do not provide support for the addition of a single pulsed dose of intravenous methylprednisolone to conventional intravenous immune globulin therapy for the routine primary treatment of children with Kawasaki disease. (ClinicalTrials.gov number, NCT00132080 [ClinicalTrials.gov].)

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

February 15, 2007

Volume

356

Issue

7

Start / End Page

663 / 675

Location

United States

Related Subject Headings

  • Pulse Therapy, Drug
  • Mucocutaneous Lymph Node Syndrome
  • Methylprednisolone
  • Male
  • Infusions, Intravenous
  • Infant
  • Immunologic Factors
  • Immunoglobulins, Intravenous
  • Humans
  • Glucocorticoids
 

Citation

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MLA
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Newburger, J. W., Sleeper, L. A., McCrindle, B. W., Minich, L. L., Gersony, W., Vetter, V. L., … Pediatric Heart Network Investigators, . (2007). Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med, 356(7), 663–675. https://doi.org/10.1056/NEJMoa061235
Newburger, Jane W., Lynn A. Sleeper, Brian W. McCrindle, L LuAnn Minich, Welton Gersony, Victoria L. Vetter, Andrew M. Atz, et al. “Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease.N Engl J Med 356, no. 7 (February 15, 2007): 663–75. https://doi.org/10.1056/NEJMoa061235.
Newburger JW, Sleeper LA, McCrindle BW, Minich LL, Gersony W, Vetter VL, et al. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med. 2007 Feb 15;356(7):663–75.
Newburger, Jane W., et al. “Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease.N Engl J Med, vol. 356, no. 7, Feb. 2007, pp. 663–75. Pubmed, doi:10.1056/NEJMoa061235.
Newburger JW, Sleeper LA, McCrindle BW, Minich LL, Gersony W, Vetter VL, Atz AM, Li JS, Takahashi M, Baker AL, Colan SD, Mitchell PD, Klein GL, Sundel RP, Pediatric Heart Network Investigators. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med. 2007 Feb 15;356(7):663–675.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

February 15, 2007

Volume

356

Issue

7

Start / End Page

663 / 675

Location

United States

Related Subject Headings

  • Pulse Therapy, Drug
  • Mucocutaneous Lymph Node Syndrome
  • Methylprednisolone
  • Male
  • Infusions, Intravenous
  • Infant
  • Immunologic Factors
  • Immunoglobulins, Intravenous
  • Humans
  • Glucocorticoids