title: Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation.
abstract: OBJECTIVE
  Treatment of HIV patients with daily tesamorelin, a growth hormone-releasing factor analogue, for 26 weeks resulted in a significant decrease in visceral adipose tissue (VAT) and improvement in lipids. The objective of the 26-week extension phase was to evaluate long-term safety and effects of tesamorelin.
  
  
  METHODS
  HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks. At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  
  
  METHODS
  Safety included adverse events and glucose parameters.
  
  
  RESULTS
  Tesamorelin was generally well tolerated. The prevalence of adverse events and serious adverse events during the extension phase was comparable with the initial phase. Changes in glucose parameters over 52 weeks were not clinically significant and similar to those after 26 weeks. The change in VAT was sustained at -18% over 52 weeks of treatment (P < 0.001 versus baseline) as was the change in triglycerides (-51 mg/dl, P < 0.001 versus baseline). Similar sustained beneficial effects were seen for total cholesterol, but high-density lipoprotein decreased minimally over 52 weeks. Upon discontinuation of tesamorelin, VAT reaccumulated.
  
  
  CONCLUSIONS
  Treatment with tesamorelin was generally well tolerated and resulted in sustained decreases in VAT and triglycerides over 52 weeks without aggravating glucose. Though effects on VAT are sustained during treatment for 52 weeks, these effects do not last beyond the duration of treatment.
authors.affiliation: Montreal General Hospital, McGill University Health Centre, Canada.
authors.forename: Julian
authors.initials: J
authors.lastname: Falutz
authors.forename: Soraya
authors.initials: S
authors.lastname: Allas
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Mamputu
authors.forename: Diane
authors.initials: D
authors.lastname: Potvin
authors.forename: Donald
authors.initials: D
authors.lastname: Kotler
authors.forename: Michael
authors.initials: M
authors.lastname: Somero
authors.forename: Daniel
authors.initials: D
authors.lastname: Berger
authors.forename: Stephen
authors.initials: S
authors.lastname: Brown
authors.forename: Gary
authors.initials: G
authors.lastname: Richmond
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Fessel
authors.forename: Ralph
authors.initials: R
authors.lastname: Turner
authors.forename: Steven
authors.initials: S
authors.lastname: Grinspoon
mesh_terms: D052242:Adiponectin / Q000097:blood; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D001823:Body Composition; D002097:C-Reactive Protein / Q000032:analysis; D002784:Cholesterol / Q000097:blood; D018592:Cross-Over Studies; D005260:Female; D013007:Growth Hormone-Releasing Hormone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D015497:HIV-1; D039682:HIV-Associated Lipodystrophy Syndrome / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D050152:Intra-Abdominal Fat / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D052242:Adiponectin; D044966:Anti-Retroviral Agents; D015415:Biomarkers; D014280:Triglycerides; D002097:C-Reactive Protein; D013007:Growth Hormone-Releasing Hormone; D002784:Cholesterol; C479538:tesamorelin