Metabolic effects of a growth hormone-releasing factor in patients with HIV.
BACKGROUND
Visceral adipose tissue accumulates during antiretroviral therapy in many patients who are infected with the human immunodeficiency virus (HIV); this process is associated with an increased cardiovascular risk. We assessed the use of a growth hormone-releasing factor analogue, tesamorelin, to decrease visceral adiposity.


METHODS
We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks. The primary end point was the percent change from baseline in visceral adipose tissue as shown on computed tomography. Secondary end points included triglyceride levels, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol, the level of insulin-like growth factor I (IGF-I), and self-assessed body image. Glycemic measures included glucose and insulin levels.


RESULTS
The measure of visceral adipose tissue decreased by 15.2% in the tesamorelin group and increased by 5.0% in the placebo group; the levels of triglycerides decreased by 50 mg per deciliter and increased by 9 mg per deciliter, respectively, and the ratio of total cholesterol to HDL cholesterol decreased by 0.31 and increased by 0.21, respectively (P<0.001 for all comparisons). Levels of total cholesterol and HDL cholesterol also improved significantly in the tesamorelin group. Levels of IGF-I increased by 81.0% in the tesamorelin group and decreased by 5.0% in the placebo group (P<0.001). Adverse events did not differ significantly between the two study groups, but more patients in the tesamorelin group withdrew from the study because of an adverse event. No significant differences were observed in glycemic measures.


CONCLUSIONS
Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles, effects that might be useful in HIV-infected patients who have treatment-associated central fat accumulation. (ClinicalTrials.gov number, NCT00123253 [ClinicalTrials.gov] .).
Montreal General Hospital, McGill University Health Centre, Montreal.
Julian
J
Falutz
Soraya
S
Allas
Koenraad
K
Blot
Diane
D
Potvin
Donald
D
Kotler
Michael
M
Somero
Daniel
D
Berger
Stephen
S
Brown
Gary
G
Richmond
Jeffrey
J
Fessel
Ralph
R
Turner
Steven
S
Grinspoon
D000273:Adipose Tissue / Q000187:drug effects*; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D001823:Body Composition / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D013007:Growth Hormone-Releasing Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000378:metabolism*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008055:Lipids / Q000097:blood; D008060:Lipodystrophy / Q000139:chemically induced / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D044966:Anti-Retroviral Agents; D008055:Lipids; D007334:Insulin-Like Growth Factor I; D013007:Growth Hormone-Releasing Hormone; C479538:tesamorelin