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6th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV25–28 October 2004 - Washington, DC, USA |
EFFECTS OF RECOMBINANT GROWTH HORMONE ON VISCERAL FAT ACCUMULATION: PILOT STUDY IN HIV-INFECTED ADOLESCENTS
Antiviral Therapy 2004; 9(6):L3 (abstract no. 1)
A Viganò1, S Mora2, P Manzoni1, L Schneider1, S Beretta1, M Molinaro3 and P Brambilla1
1 Chair of Paediatrics, L Sacco Hospital, University of Milan, Milan, Italy; 2 Laboratory of Paediatric Endocrinology, IRCCS HS Raffaele, Milan, Italy; and 3 Department of Pharmacology, IRCCS S Matteo Hospital, Pavia, Italy
BACKGROUND: Recent data showed that recombinant human growth hormone (rhGH) reduces abnormal visceral adipose tissue (VAT) accumulation in HIV-infected adults with lipodystrophy. However, the administration of rhGH may carry unwanted side effects. To date, no studies have evaluated the effect of rhGH in HIV-infected lipodystrophic children with VAT accumulation.
METHODS: Prospective, open-label study of 24 weeks of rhGH 0.028 mg/kg/daily. Nine HIV-infected adolescents (age range 10.6–18.7 years) with abnormal VAT accumulation (>41 cm2 at L4-MRI) were enrolled. The main outcome measure was change in VAT on L4-MRI. Changes in body composition by DXA, glucose metabolism, lipid profile and IGF-1 were also evaluated.
RESULTS: From baseline to week 24: BMI remained stable [21.3 (2.6) vs 21.2 (2.4)]; VAT decreased significantly [81.1 (35.6) vs 48.9 (25.8) cm2; P=0.01]; total fat percentage decreased significantly [23.4 (7.2) vs 20.4 (7.6); P=0.03]; and total and regional fat mass decreased, but not significantly. Lean mass increased significantly as a total (38.6 vs 42.2 kg; P=0.0008), at arms (3.4 vs 3.9 kg; P=0.001), legs (12.9 vs 14.2 kg; P=0.0013) and trunk [19.3 vs 20.9 kg; P=.0035] level; bone mineral content (BMC) increased significantly (17.9 vs 19.5 g; P=0.03). IGF-1 level increased twofold within 1 month of rhGH and this increase was maintained throughout the 24 weeks. Insulin and glucose areas under the curve from OGTT did not change from baseline to 24 weeks; fasting and post-prandial glycaemia remained within normal limits at monthly controls. Fasting triglyceride levels did not change significantly from baseline to week 24 (125 vs 144 mg/dl); four children showed hypertrygliceridaemia (>150 mg/dl) at baseline and maintained it throughout the study. Fasting total (164 vs 158), HDL (47 vs 44) and LDL (92 vs 81) cholesterol (mg/dl) did not change; only one child showed hypercholesterolaemia (>200 mg/dl). No major side effects were detected; only one child complained of transient hand swelling.
CONCLUSION: Our data suggest that 0.028 mg/kg/daily of rhGH achieved a consistent VAT reduction, a significant increase in BMC and lean mass and decrease in total adiposity. Overall rhGH treatment was well tolerated and it was not associated with a worsening of glucose and lipid metabolism.
2004-10-25
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