TY - JOUR
T1 - Five-year outcomes after oxandrolone administration in severely burned children
T2 - A randomized clinical trial of safety and efficacy
AU - Porro, Laura J.
AU - Herndon, David N.
AU - Rodriguez, Noe A.
AU - Jennings, Kristofer
AU - Klein, Gordon L.
AU - Mlcak, Ronald P.
AU - Meyer, Walter J.
AU - Lee, Jong O.
AU - Suman, Oscar E.
AU - Finnerty, Celeste C.
PY - 2012/4
Y1 - 2012/4
N2 - Background: Oxandrolone, an anabolic agent, has been administered for 1 year post burn with beneficial effects in pediatric patients. However, the long-lasting effects of this treatment have not been studied. This single-center prospective trial determined the long-term effects of 1 year of oxandrolone administration in severely burned children; assessments were continued for up to 4 years post therapy. Study Design: Patients 0 to 18 years old with burns covering >30% of the total body surface area were randomized to receive placebo (n = 152) or oxandrolone, 0.1 mg/kg twice daily for 12 months (n = 70). At hospital discharge, patients were randomized to a 12-week exercise program or to standard of care. Resting energy expenditure, standing height, weight, lean body mass, muscle strength, bone mineral content (BMC), cardiac work, rate pressure product, sexual maturation, and concentrations of serum inflammatory cytokines, hormones, and liver enzymes were monitored. Results: Oxandrolone substantially decreased resting energy expenditure and rate pressure product, increased insulin-like growth factor-1 secretion during the first year after burn injury, and, in combination with exercise, increased lean body mass and muscle strength considerably. Oxandrolone-treated children exhibited improved height percentile and BMC content compared with controls. The maximal effect of oxandrolone was found in children aged 7 to 18 years. No deleterious side effects were attributed to long-term administration. Conclusions: Administration of oxandrolone improves long-term recovery of severely burned children in height, BMC, cardiac work, and muscle strength; the increase in BMC is likely to occur by means of insulin-like growth factor-1. These benefits persist for up to 5 years post burn.
AB - Background: Oxandrolone, an anabolic agent, has been administered for 1 year post burn with beneficial effects in pediatric patients. However, the long-lasting effects of this treatment have not been studied. This single-center prospective trial determined the long-term effects of 1 year of oxandrolone administration in severely burned children; assessments were continued for up to 4 years post therapy. Study Design: Patients 0 to 18 years old with burns covering >30% of the total body surface area were randomized to receive placebo (n = 152) or oxandrolone, 0.1 mg/kg twice daily for 12 months (n = 70). At hospital discharge, patients were randomized to a 12-week exercise program or to standard of care. Resting energy expenditure, standing height, weight, lean body mass, muscle strength, bone mineral content (BMC), cardiac work, rate pressure product, sexual maturation, and concentrations of serum inflammatory cytokines, hormones, and liver enzymes were monitored. Results: Oxandrolone substantially decreased resting energy expenditure and rate pressure product, increased insulin-like growth factor-1 secretion during the first year after burn injury, and, in combination with exercise, increased lean body mass and muscle strength considerably. Oxandrolone-treated children exhibited improved height percentile and BMC content compared with controls. The maximal effect of oxandrolone was found in children aged 7 to 18 years. No deleterious side effects were attributed to long-term administration. Conclusions: Administration of oxandrolone improves long-term recovery of severely burned children in height, BMC, cardiac work, and muscle strength; the increase in BMC is likely to occur by means of insulin-like growth factor-1. These benefits persist for up to 5 years post burn.
KW - BMC
KW - BMD
KW - CO
KW - HR
KW - IGF-1
KW - IGFBP
KW - IL
KW - REE
KW - RPP
KW - TBSA
KW - bone mineral content
KW - bone mineral density
KW - cardiac output
KW - heart rate
KW - insulin-like growth factor-1
KW - insulin-like growth factor-binding protein
KW - interleukin
KW - rate pressure product
KW - resting energy expenditure
KW - total body surface area
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U2 - 10.1016/j.jamcollsurg.2011.12.038
DO - 10.1016/j.jamcollsurg.2011.12.038
M3 - Article
C2 - 22463890
AN - SCOPUS:84859192647
SN - 1072-7515
VL - 214
SP - 489
EP - 502
JO - Journal of the American College of Surgeons
JF - Journal of the American College of Surgeons
IS - 4
ER -