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6th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV25–28 October 2004 - Washington, DC, USA |
EFFECTS OF A GROWTH HORMONE RELEASING FACTOR (GRF) ANALOGUE IN HIV PATIENTS WITH ABDOMINAL FAT ACCUMULATION: A RANDOMIZED PLACEBO-CONTROLLED TRIAL
Antiviral Therapy 2004; 9(6):L4 (abstract no. 2)
S Grinspoon1, D Kotler2, S Allas3, B Lussier3, A Chapdelaine3, JM Tellier3, MC Domec3, L Vachon3, T Abribat3 and J Falutz4
1 Massachussetts General Hospital, Boston, Mass., USA; 2 St Luke's Roosevelt Hospital Center, New York, NY, USA; and 3 Theratechnologies, Inc., Montreal, Que., Canada and Montreal General Hospital, Montreal, Que., Canada
BACKGROUND: Patients treated with antiretroviral therapy may demonstrate accumulation of abdominal fat and reduced growth hormone concentrations. TH9507, a GRF analogue with a longer half-life than the natural peptide, has been shown to increase IGF-1 levels within the physiological range and to safely improve body composition in non HIV-infected patients.
METHODS: We investigated the effects of TH9507 in patients with HIV lipodystrophy and conducted a multicentre, randomized, double-blind, placebo-controlled study in 61 HIV-infected patients (54 men, 7 women) with increased waist circumference (WC) (≥95 cm for men, ≥94 cm for women) and waist to hip ratio (WHR) (≥0.94 for men, ≥0.88 for women). Patients received placebo or TH9507 at 1 or 2 mg sc daily for 12 weeks. Visceral adipose tissue was assessed by CT scan at L4-5 and body composition by DXA.
RESULTS: Baseline mean age was 46 ±7 (SD), BMI 28 ±3 (SD) kg/m2, WC 102 cm ±8 (SD) and WHR 1.0 ±0.1 (SD). Study population included patients with type 2 diabetes or glucose intolerance. At week 12, serum IGF-1 levels increased over baseline by 59% and 80% at 1 mg and 2 mg, respectively (P<0.001 vs placebo). At 2 mg, lean body mass increased (+1.7 kg, P<0.01 vs placebo) and body fat was preferentially lost at the trunk level (–1.1 kg, P<0.02 vs placebo) with no significant change in limb fat. There was a decrease in visceral fat (–15.7% for the 2 mg group, P<0.05 vs baseline; –5.4% for the placebo group, NS vs baseline) whereas subcutaneous fat was preserved. Lipid profile improved with reduction in cholesterol to HDL ratio. Both doses were well tolerated including with regard to glycaemic control.
CONCLUSION: These results demonstrate that a single daily administration of TH9507 for 12 weeks safely increased lean mass, and decreased abdominal fat with a reduction in visceral fat and preservation of subcutaneous fat in patients with HIV lipodystrophy. TH9507, a GRF analogue, may be a beneficial treatment strategy for this population.
2004-10-25
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