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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 - pdf attached
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Download the PDF here
Falutz, Julian; Potvin, Diane; Mamputu, Jean-Claude; Assaad, Hani; Zoltowska, Monika; Michaud, Sophie-Elise; Berger, Daniel; Somero, Michael; Moyle, Graeme; Brown, Stephen; Martorell, Claudia; Turner, Ralph; Grinspoon, Steven
JAIDS Journal of Acquired Immune Deficiency Syndromes., POST AUTHOR CORRECTIONS, 23 January 2010
"In contrast to a prior study of tesamorelin, the current study did not show a significant decrease in triglycerides, but rather a trend, amounting to a net reduction in triglycerides of 26 mg/dL compared with placebo over 6 months. The treatment effect was larger in the prior study, 59 mg/dL, but entry triglyceride levels were higher in that study.14 One explanation may be that the current study included European sites, where dietary and lifestyle patterns may differ. Importantly, a similar proportion of patients were receiving PIs in both studies. TC was reduced significantly for subjects receiving tesamorelin for 12 months in the current study suggesting at least 1 additional cardiovascular benefit beyond that of a reduction in VAT......The effects of tesamorelin on body image are important and consistent between the 2 Phase III studies"
"Tesamorelin is not yet approved for use in North America or Europe. However, we now report completion of a second Phase III study, again demonstrating significant efficacy of tesamorelin (18% reduction in VAT) and good safety with ongoing treatment to 12 months in a randomized placebo-controlled study of over 400 patients. With these new data, there are now consistent results from 2 large Phase III, randomized placebo-controlled studies to suggest that this is a potentially useful clinical strategy to selectively reduce VAT and improve body image among HIV-infected patients with abdominal fat accumulation in the context of ART treatment."
Abstract:
Background: HIV-infected patients receiving antiretroviral therapy often demonstrate excess visceral fat. A growth hormone-releasing factor, tesamorelin, may selectively reduce visceral fat in this population. We investigated the effects of tesamorelin (GHRH1-44) in HIV-infected patients with central fat accumulation.
Methods: A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008. The study consisted of 2 sequential phases. In the primary efficacy phase (months 0-6), patients were randomly assigned to receive tesamorelin [2 mg subcutaneous (SC) every day] or placebo in a 2:1 ratio. In the extension phase (months 6-12), patients receiving tesamorelin were rerandomized to continue on tesamorelin (2 mg SC every day) or switch to placebo. Patients initially randomized to placebo switched to tesamorelin. Patients and investigators were blinded to treatment assignment throughout the study. The primary endpoint was visceral adipose tissue (VAT). Secondary endpoints included body image, IGF-I, safety measures, including glucose, and other body composition measures.
Results: VAT decreased by -10.9% (-21 cm2) in the tesamorelin group vs. -0.6% (-1 cm2) in the placebo group in the 6-month efficacy phase, P < 0.0001. Trunk fat (P < 0.001), waist circumference (P = 0.02), and waist-hip-ratio (P = 0.001) improved, with no change in limb or abdominal SC fat. Insulin-like growth factor-1 increased (P < 0.001), but no change in glucose parameters was observed. Patient rating of belly appearance distress (P = 0.02) and physician rating of belly profile (P = 0.02) were significantly improved in the tesamorelin vs. placebo-treated groups. The drug was well tolerated. VAT was reduced by approximately 18% (P < 0.001) in patients continuing tesamorelin for 12 months. The initial improvements over 6 months in VAT were rapidly lost in those switching from tesamorelin to placebo.
Conclusions: Tesamorelin reduces visceral fat by approximately 18% and improves body image distress in HIV-infected patients with central fat accumulation. These changes are achieved without significant side effects or perturbation of glucose.
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