Tesamorelin for the treatment of excess abdominal fat in HIV-1-infected patients with lipodystrophy

References

• Villarroya F, Domingo P, Giralt M. Lipodystrophy associated with highly active anti-retroviral therapy for HIV infection: the adipocyte as a target of anti-retroviral-induced mitochondrial toxicity. Trends Pharmacol. Sci.26, 88–93 (2005).
   PubMed Web of Science ®Google Scholar
• Mallon PW, Miller J, Cooper DA et al. Prospective evaluation of the effects of antiretroviral therapy on body composition in HIV-1-infected men starting therapy. AIDS17(7), 971–979 (2003).
   PubMed Web of Science ®Google Scholar
• Dube MP, Parker RA, Tebas P et al. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS19, 1807–1818 (2005).
   PubMed Web of Science ®Google Scholar
• Friis-Moller N, Sabin CA, Weber R et al. Combination antiretroviral therapy and the risk of myocardial infarction. N. Engl. J. Med.349, 1993–2003 (2003).
   PubMed Web of Science ®Google Scholar
• Grinspoon S, Carr A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N. Engl. J. Med.352, 48–62 (2005).
   PubMed Web of Science ®Google Scholar
• Milinkovic A, Vidal S, Bianchi L et al. Comparative assessment of objective methods for the measurement of body fat. Antivir. Ther.8, L63 (2003).
   Google Scholar
• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA285, 2486–2497 (2001).
   PubMed Web of Science ®Google Scholar
• Guaraldi G, Stentarelli C, Zona S et al. Lipodystrophy and anti-retroviral therapy as predictors of sub-clinical atherosclerosis in HIV infected subjects. Atherosclerosis208, 222–227 (2010).
   PubMed Web of Science ®Google Scholar
• Guaraldi G, Zona S, Orlando G et al. Visceral fat but not general adiposy is a predictor of cardiovascular disease in HIV-infected males. Presented at: 17th Conference on Retroviruses and Opportunistic Infection. San Francisco, CA, USA, 16–19 February 2010.
   Google Scholar
• Snel Y, Brummer R-JM, Doerga ME et al. Adipose tissue assessed by magnetic resonance imaging in growth hormone deficient adults: the effect of growth hormone replacement and a comparison with control subject. Am. J. Clin. Nutr.61, 1290–1294 (1995).
   PubMed Web of Science ®Google Scholar
• De Boer H, Blok GJ, Voerman B et al. Changes in subcutaneous and visceral fat mass during growth hormone replacement therapy in adult men. Int. J. Obes. Relat. Metab. Disord.20, 580–587 (1996).
   PubMed Web of Science ®Google Scholar
• Rietschel P, Hadigan C, Corcoran C et al. Assessment of growth hormone dynamics in human immunodeficiency virus-related lipodystrophy. J. Clin. Endocrinol. Metab.86, 504–510 (2001).
   PubMed Web of Science ®Google Scholar
• Koutkia P, Meininger G, Canavan B et al. Metabolic regulation of growth hormone by free fatty acids, somatostatine, and ghrelin in HIV-lipodystrophy. Am. J. Physiol. Endocrinol. Metab.286, E296–E303 (2004).
   PubMedGoogle Scholar
• Torres RA, Unger KW, Cadman JA et al. Recombinant human growth hormone improves truncal adiposity and “buffalo humps” in HIV-positive patients on HAART [letter]. AIDS13, 2479–2481 (1999).
   PubMed Web of Science ®Google Scholar
• Wanke C, Gerrior J, Kantaros J et al. Recombinant human growth hormone improves the fat redistribution syndrome (lipodystrophy) in patients with HIV. AIDS13, 2099–2103 (1999).
   PubMed Web of Science ®Google Scholar
• Lo JC, Mulligan K, Noor MA et al. The effects of recombinant human growth hormone on body composition and glucose metabolism in HIV-infected patients with fat accumulation. J. Clin. Endocrinol. Metab.86, 3480–3487 (2001).
   PubMed Web of Science ®Google Scholar
• Engelson ES, Glesby MJ, Mendez D et al. Effect of recombinant human growth hormone in the treatment of visceral fat accumulation in HIV infection. J. Acquir. Immune Defic. Syndr.30, 379–391 (2002).
   PubMed Web of Science ®Google Scholar
• Schwarz JM, Mulligan K, Lee J et al. Effects of recombinant human growth hormone on hepatic lipid and carbohydrate metabolism in HIV-infected patients with fat accumulation. J. Clin. Endocrinol. Metab.87, 942 (2002).
   PubMed Web of Science ®Google Scholar
• Chan JM, Stampfer MJ, Giovannucci E et al. Plasma IGF-1 and prostate cancer risk: a prospective study. Science279, 563–566 (1998).
   PubMed Web of Science ®Google Scholar
• Hankinson SE, Willett WC, Colditz GA et al. Circulating concentrations of IGF-1 and the risk of breast cancer. Lancet351, 1393–1396 (1998).
   PubMed Web of Science ®Google Scholar
• Ma J, Pollak MN, Giovannuci E et al. Prospective study of colorectal cancer risk in men and plasma levels of insulin-like growth factor (IGF)-I and IGF-binding protein-3. J. Natl Cancer Inst.91(7), 620–625 (1999).
   PubMed Web of Science ®Google Scholar
• Koutkia P, Canavan B, Breu J et al. Growth hormone-releasing hormone in HIV-infected men with lipodystrophy: a randomized, controlled trial. JAMA292, 210–218 (2004).
   PubMed Web of Science ®Google Scholar
• Lönn L, Johannsson G, Sjöström L et al. Body composition and tissue distribution in growth hormone deficient adults before and after growth hormone treatment. Obes. Res.4, 45–54 (1996).
   PubMedGoogle Scholar
• Falutz J, Allas S, Kotler D et al. A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with abdominal fat accumulation. AIDS19, 1279–1287 (2005).
   PubMed Web of Science ®Google Scholar
• Falutz J, Allas S, Blot K et al. Metabolic effects of a growth hormone releasing factor in patients with HIV. N. Engl. J. Med.357, 2359–2370 (2007).
   PubMed Web of Science ®Google Scholar
• Falutz J, Allas S, Mamputu J-C et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS22, 1719–1728 (2008).
   PubMed Web of Science ®Google Scholar
• Falutz J, Potvin D, Mamputu J-C et al. Effects of tesamorelin, a growth hormone releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized, placebo-controlled, trial with a safety extension. J. Acquir. Immune Defic. Syndr.53(3), 311–322 (2010).
   PubMed Web of Science ®Google Scholar
• Frohman LA, Downs TR, Williams TC et al. Rapid enzymatic degradation of growth hormone-releasing hormone by plasma in vitro and in vivo to a biologically inactive product cleaved at the NH2-terminus. J. Clin. Invest.78, 906–991 (1986).
   PubMedGoogle Scholar
• Larocque A, Vaillancourt C, Abribat T et al. Anchoring rigid hydrophobic chains to stabilize growth hormone-releasing factor. Theratechnologies Inc., St. Laurent and University of Montreal, Montreal, Quebec, Canada (2001).
   Google Scholar
• Michaud S-E, Abolfathi Z. Pharmacokinetic/pharmacodynamic evaluation of tesamorelin (TH9507), a growth hormone-releasing factor (GRF) analog, administered subcutaneously once daily for 14 consecutive days in healthy and HIV positive populations. Presented at: Endocrine Society’s 91st Annual Meeting. Washington, DC, USA, 10–13 June 2009.
   Google Scholar
• Falutz J, Mamputu J-C. Metabolic effects of tesamorelin (TH9507), a growth hormone-releasing factor analogue, in hiv-infected patients with excess abdominal fat over a period of 52 weeks. a pooled analysis of 2 multicenter, double- blind, placebo-controlled Phase 3 trials with 816 randomized patients. Presented at: 12th European AIDS Conference. Cologne, Germany, 11–14 November 2009.
   Google Scholar
• Ferdinandi ES, Brazeau P, High K et al. Non-clinical pharmacology and safety evaluation of TH9507, a human growth hormone-releasing factor analogue. Basic Clin. Pharmacol. Toxicol.100(1), 49–58 (2007).
   PubMed Web of Science ®Google Scholar
• Vincent G, Teng S. Impact of tesamorelin (TH9507), a stabilized growth hormone-releasing factor (GRF) analogue, on the pharmacokinetics of simvastatin and ritonavir in healthy volunteers. Presented at: 18th Annual Canadian Conference on HIV/AIDS Research. Vancouver, BC, Canada, 23–26 April 2009.
   Google Scholar