title: Effects of tesamorelin on inflammatory markers in HIV patients with excess abdominal fat: relationship with visceral adipose reduction.
abstract: OBJECTIVE
  To report the effects of tesamorelin, a growth hormone-releasing hormone analogue, on inflammatory and fibrinolytic markers and to relate these effects to changes in visceral adipose tissue (VAT).
  
  
  METHODS
  Four hundred and ten HIV-infected patients with abdominal adiposity were randomized to 2 mg tesamorelin (n = 273) or placebo (n = 137) subcutaneously daily for 26 weeks. Circulating plasminogen activator inhibitor-1 (PAI-1) antigen, tissue plasminogen activator (tPA) antigen, C-reactive protein (CRP), and adiponectin were assessed.
  
  
  RESULTS
  At baseline, VAT was significantly associated with PAI-1 antigen (ρ = 0.36, P < 0.001), tPA antigen (ρ = 0.29, P < 0.001), CRP (ρ = 0.18, P < 0.001), and adiponectin (ρ = -0.22, P < 0.001). Treatment with tesamorelin resulted in a significant decrease from baseline in tPA antigen (-2.2 ± 2.5 vs. -1.6 ± 2.9 ng/ml, tesamorelin vs. placebo, P < 0.05). Changes in PAI-1 antigen were not significant in the tesamorelin group compared to placebo. Among patients receiving tesamorelin, changes in inflammatory markers were associated with change in VAT (PAI-1 antigen: ρ = 0.16, P = 0.02; tPA antigen: ρ = 0.16, P = 0.02; adiponectin: ρ = -0.27, P < 0.001), and these associations remained significant when controlling for changes in insulin-like growth factor-1.
  
  
  CONCLUSIONS
  In HIV patients with abdominal adiposity, tesamorelin may have a modest beneficial effect on adiponectin and fibrinolytic markers in association with changes in VAT. Further studies are needed to determine the clinical significance of these changes. These data further highlight the deleterious role of excessive VAT and the utility of strategies to improve VAT in this population.
authors.affiliation: Program in Nutritional Metabolism, Massachusetts General Hospital, Boston, 02114, USA.
authors.forename: Takara L
authors.initials: TL
authors.lastname: Stanley
authors.forename: Julian
authors.initials: J
authors.lastname: Falutz
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Mamputu
authors.forename: Graziella
authors.initials: G
authors.lastname: Soulban
authors.forename: Diane
authors.initials: D
authors.lastname: Potvin
authors.forename: Steven K
authors.initials: SK
authors.lastname: Grinspoon
mesh_terms: D050153:Abdominal Fat / Q000187:drug effects* / Q000276:immunology; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D015415:Biomarkers / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism*; D005260:Female; D013007:Growth Hormone-Releasing Hormone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D007249:Inflammation / Q000378:metabolism*; D050152:Intra-Abdominal Fat / Q000187:drug effects* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D017395:Plasminogen Activator Inhibitor 1 / Q000378:metabolism*; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D010919:Placebos; D017395:Plasminogen Activator Inhibitor 1; D002097:C-Reactive Protein; D013007:Growth Hormone-Releasing Hormone; C479538:tesamorelin