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Reduction in Visceral Adipose Tissue (VAT) with Tesamorelin Correlates with Changes in Anthropometric, and Patient-Reported Outcome (PRO) Parameters in HIV+ Patients with Excess Abdominal Fat
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Reported by Jules Levin
ICAAC Boston Sept 13 2010
Julian Falutz1, Sophie elise Michaud2, Josee Morin2, Steve Glyman3, and Steven Grinspoon4
1Montreal General Hospital, McGill University Health Centre; 2Theratechnologies Inc., Montreal, Quebec, Canada; 3EMD Serono, Boston MA, 4Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
"Assessment of VAT using CT scan is a research technique, but the degree to which VAT is reduced in response to tesamorelin is apparent to patients based on significant reductions in WC and improvements in body image that are correlated with reductions in VAT."
ABSTRACT
Background: Increased visceral adipose tissue (VAT) is common in HIV+ patients treated with antiretroviral therapy and improves significantly with tesamorelin treatment. In this study we investigated whether the decrease in VAT with tesamorelin correlates with anthropometric and patient reported outcome (PRO) parameters.
Methods: 816 HIV+ patients with increased waist circumference (WC) were randomized in 2 studies to receive tesamorelin 2 mg (n=550) or placebo (n=266) sc daily for 26 weeks. The primary endpoint was the % change from baseline in VAT by computerized tomography (CT) scan. Data were analyzed using ANCOVA and Spearman's correlations.
Results: At baseline, mean age was 48 yrs, WC 105 cm, VAT 182 cm2. At Week 26, VAT and WC decreased from baseline in tesamorelin-treated patients (-13.1%; -2.4cm, respectively, p<0.001 vs. placebo for both). Treatment with tesamorelin was associated with a clinically significant improvement (defined as a responsiveness unit ≥ 0.15) in PRO parameters such as belly appearance distress, patient and physician- rated belly profile (0.15, 0.32, and 0.25, respectively). The % change from baseline in VAT correlated with change in WC, and PRO parameters in the tesamorelin group, with the strongest correlation observed with WC (0.442 p<0.001), followed by patient-rated belly profile (-0.341 p<0.01). Also, the change in WC correlated with PRO parameters with the strongest correlation for patient-rated belly profile (-0.396 p<0.001).
Conclusion: Tesamorelin significantly decreases VAT in HIV+ patients with excess abdominal fat. Assessment of VAT using CT scan is a research technique, but the degree to which VAT is reduced in response to tesamorelin is apparent to patients based on significant reductions in WC and improvements in body image that are correlated with reductions in VAT.
INTRODUCTION
· A significant number of HIV patients on antiretroviral therapy (ART) develop excess abdominal fat and metabolic abnormalities including dyslipidemia and insulin resistance (1). Accumulating evidence indicate that these patients are at increased risk of cardiovascular diseases (2, 3, 4).
· Results from two phase 3 studies demonstrate that tesamorelin, a stabilized analogue of growth hormone- releasing factor (GRF)/growth hormone-releasing hormone (GHRH), significantly reduces VAT, improves lipid profile as well as patient-reported outcomes related to body image.
· In this study, we investigated whether the decrease in VAT following tesamorelin treatment correlates with anthropometric and PRO parameters.
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