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  AIDS 2002 Barcelona
Barcelona, Spain July 7-12 2002
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Human Growth Hormone for Lipodystrophy: daily vs alternate day dosing
Reported by Jules Levin
  At Barcelona Donald Kotler, MD, (St Lukes-Roosevelt Med Ctr, NYC) reported new information from a study comparing daily vs alternate day dosing of Human Growth Hormone (HGH). Most of us know by now that many HIV-infected individuals are developing fat loss (also called lipoatrophy) in the periphery (face, legs, buttocks, arms, etc), and fat accumulation, particularly in the belly. Fat loss in the face is particularly disturbing for HIV-infected individuals. Fat accumulation can occur in other areas of the body such as the breasts, a particular concern for women. Women tend to accumulate fat in the trunk. The causes for these problems are not understood. Oftentimes, the body changes, also called fat redistribution, are accompanied by abnormalities in glucose, cholesterol, triglycerides, and other lipid values. Research into understanding these problems continue but progress is slow.
Previous studies have found that the use of HGH can reduce fat accumulation. But it's reported that the benefit fades after stopping the HGH. The use of HGH is accompanied by certain side effects and potential toxicities, particularly increasing glucose (a risk for patients with diabetes or disposition for diabetes). There is also a potential concern about reducing fat in the face or other areas where you may not want to reduce fat. So, if you have facial fat loss HGH be cautious. Some patients have reported increased fat in face but this may be due to water retention. HGH is not approved for use for treating lipodystrophy, but is approved for HIV related wasting. The manufacturer, Serono, is conducting a study in persons with lipodystrophy.
In Kotler's study about 240 patients were equally randomized to 4 mg SC daily, 4 mg SC alternate day dosing, or placebo. These patients were followed for 12 weeks before being assigned to different dosing for an additional 12 weeks. To qualify for the study patients had to have excess visceral fat (fat in belly) as measured by waist circumfrance & waist:hip ratio. Patients could not be diabetic nor receiving medications for diabetes. Lipid-lowering agents were permitted. Fasting glucose had to be <110 mg/dl (6.1 mM). 2 hour glucose testing had to be <140 mg/dl (7.8 mM) following 75 mg glucose.
85% of patients were men. CD4 was 450, BMI 26-27. Percent of body fat 20%. Trunk/limb fat ratio 2.3:1. And VAT (cm2) 320- visceral adipose tissue.
Visceral adiposity (fat in belly) as measured by CT scan was reduced significantly in the daily dose growth hormone group (p<0.001) and the change approached statistical significance in the alternate daily dose group (p=0.052). Trunk to limb fat ratio (by DEXA) fell significantly in both growth hormone treatment groups (p<0.001). Total fat and trunk fat as measured by DEXA were reduced significantly in both the AD & DD groups. Limb fat was reduced a little in the AD & DD arms but a little more in the DD group.
Patients experienced increases in fasting glucose compared to the placebo group (p<0.05). Placebo group showed no increase but in the DD group glucose increased from 90 to 100. In the AD group glucose increased from 96 to 102. As with previous studies the most common adverse events associated with growth hormone therapy included arthralgia, myalgia and peripheral oedema.
There were significant declines in total cholesterol from 215 to 210 in AD dose regimen and from 210 to 200 in the DD regimen. There were also significant declines in non-HDL cholesterol (bad cholesterol) from 180 to 170 in AD group and from 172 to 155 in the DD group. So, cholesterol improvements were greater in the daily dosing group.
Patients reported improved health-related quality of life. Kotler concluded "induction therapy" with HGH 4 mg daily for 12 weeks is effective in the treatment of fat accumulation.