Effects of growth hormone on abnormal visceral adipose tissue accumulation and dyslipidemia in HIV-infected patients.
BACKGROUND
Some HIV-infected patients develop fat maldistribution with visceral adipose tissue (VAT) accumulation and metabolic abnormalities. No medical treatment is approved by the US Food and Drug Administration to reduce VAT.


METHODS
In this double-blind trial, 245 HIV-infected patients with excess VAT were randomized to receive placebo (PL), recombinant human growth hormone (r-hGH) at a dose of 4 mg daily (DD) or 4 mg on alternate days (AD) for 12 weeks. For weeks 12 to 24, DD patients were rerandomized to PL (DD-PL) or AD (DD-AD), AD patients continued on AD (AD-AD), and PL patients were switched to DD (PL-DD).


RESULTS
From baseline to week 12, VAT decreased significantly compared with PL in DD (-8.6%, P < 0.001) but not in AD (-4.2%, P = 0.052). Trunk-to-limb fat ratio decreased significantly in both (P < 0.001) compared with PL, as did total cholesterol and non-high-density lipoprotein (HDL) cholesterol (-4.5% and -7.5% in DD, -4.3% and -6.2% in AD). At week 24, all groups displayed significant (P < 0.05) reductions in VAT (-5.3% to -9.5%) and trunk fat (-7.8% to -22.8%). DD-AD and AD-AD also displayed significant (P < 0.05) reductions in non-HDL cholesterol.


CONCLUSIONS
These results suggest that r-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT. The optimal regimen to sustain these effects awaits determination.
Kotler
Donald P
DP
Division of GI Immunology, St. Luke's Roosevelt Hospital Center, New York, NY, USA.
Muurahainen
Norma
N
Grunfeld
Carl
C
Wanke
Christine
C
Thompson
Melanie
M
Saag
Michael
M
Bock
Daena
D
Simons
Gregg
G
Gertner
Joseph M
JM
D000273:Adipose Tissue / Q000033:anatomy & histology* / Q000187:drug effects; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D002784:Cholesterol / Q000097:blood; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology*; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D044469:Racial Groups; D015203:Reproducibility of Results; D014781:Viscera
D019380:Anti-HIV Agents; D010919:Placebos; D019382:Human Growth Hormone; D002784:Cholesterol