Effects of oxandrolone on outcome measures in the severely burned: a multicenter prospective randomized double-blind trial.
Severe burns induce pathophysiologic problems, among them catabolism of lean mass, leading to protracted hospitalization and prolonged recovery. Oxandrolone is an anabolic agent shown to decrease lean mass catabolism and improve wound healing in the severely burned patients. We enrolled 81 adult subjects with burns 20% to 60% TBSA in a multicenter trial testing the effects of oxandrolone on length of hospital stay. Subjects were randomized between oxandrolone 10 mg every 12 hours or placebo. The study was stopped halfway through projected enrollment because of a significant difference between groups found on planned interim analysis. We found that length of stay was shorter in the oxandrolone group (31.6 +/- 3.1 days) than placebo (43.3 +/- 5.3 days; P < .05). This difference strengthened when deaths were excluded and hospital stay was indexed to burn size (1.24 +/- 0.15 days/% TBSA burned vs 0.87 +/- 0.05 days/% TBSA burned, P < .05). We conclude that treatment using oxandrolone should be considered for use in the severely burned while hepatic transaminases are monitored.
BART (Burn Applied Research Team): the Blocker Burn Unit University of Texas Medical Branch, USA.
Steven E
SE
Wolf
Linda S
LS
Edelman
Nathan
N
Kemalyan
Lorraine
L
Donison
James
J
Cross
Marcia
M
Underwood
Robert J
RJ
Spence
Dene
D
Noppenberger
Tina L
TL
Palmieri
David G
DG
Greenhalgh
Marybeth
M
Lawless
David
D
Voigt
Paul
P
Edwards
Petra
P
Warner
Richard
R
Kagan
Susan
S
Hatfield
James
J
Jeng
Daria
D
Crean
John
J
Hunt
Gary
G
Purdue
Agnes
A
Burris
Bruce
B
Cairns
Mary
M
Kessler
Robert L
RL
Klein
Rose
R
Baker
Charles
C
Yowler
Wendy
W
Tutulo
Kevin
K
Foster
Daniel
D
Caruso
Brian
B
Hildebrand
Wesley
W
Benjamin
Cynthia
C
Villarreal
Arthur P
AP
Sanford
Jeffrey
J
Saffle
D000293:Adolescent; D000328:Adult; D000368:Aged; D045930:Anabolic Agents / Q000627:therapeutic use*; D002056:Burns / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010074:Oxandrolone / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome
D045930:Anabolic Agents; D010074:Oxandrolone; D000637:Transaminases