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.
Wolf
Steven E
SE
BART (Burn Applied Research Team): the Blocker Burn Unit University of Texas Medical Branch, USA.
Edelman
Linda S
LS
Kemalyan
Nathan
N
Donison
Lorraine
L
Cross
James
J
Underwood
Marcia
M
Spence
Robert J
RJ
Noppenberger
Dene
D
Palmieri
Tina L
TL
Greenhalgh
David G
DG
Lawless
Marybeth
M
Voigt
David
D
Edwards
Paul
P
Warner
Petra
P
Kagan
Richard
R
Hatfield
Susan
S
Jeng
James
J
Crean
Daria
D
Hunt
John
J
Purdue
Gary
G
Burris
Agnes
A
Cairns
Bruce
B
Kessler
Mary
M
Klein
Robert L
RL
Baker
Rose
R
Yowler
Charles
C
Tutulo
Wendy
W
Foster
Kevin
K
Caruso
Daniel
D
Hildebrand
Brian
B
Benjamin
Wesley
W
Villarreal
Cynthia
C
Sanford
Arthur P
AP
Saffle
Jeffrey
J
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