Growth hormone reduces fat accumulation

Dramatic belly-reduction photographs graphically

illustrated the results of the first multicentre,

double-blind, placebo-controlled, randomised, parallel

group phase II/III trial on the effects of recombinant

human growth hormone (GH) on lipohypertrophy that were

presented today by lead investigator, Donald Kotler,

on behalf of Serono - manufacturers of Serostim - in a

late-breaker session at the XIVth International AIDS

Conference in Barcelona.

The STARS trial (Serostim in the Treatment of Adipose

Redistribution Syndrome) or Serono protocol 22388,

found that 4mg GH daily (a 33% reduction in the

currently approved dose for AIDS wasting)

significantly reduced viceral adipose tissue (VAT)

accumulation compared with placebo.

Kotler argued that GH is unique as a therapy for

lipodystrophy because, unlike anabolic steroids, it

preferentially depletes central adipose tissue to a

greater degree than subcutaneous adipose tissue in the

face and extremities. He suggested that 4 mg GH daily

could be considered to be "induction therapy", adding

that more research is ongoing to assess the efficacy

and long-term safety of low dose GH maintainance

therapy in order to sustain its beneficial effects.

As previously reported on aidsmap, two sites in London

are currently recruiting for the HALT study, which

includes low dose (2mg daily) GH amongst its five

treatment arms.

In the STARS trial, 239 people (13% female, 20%

non-caucasian) with symptoms of HARS (HIV-associated

Adipose Redistribution Syndrome) at 23 US sites were

randomised to one of three arms: 4mg GH daily, 4mg GH

and placebo on alternate days, and placebo, by

self-administered subcutaneous injection. Reductions

of VAT were assessed by CT scan, and ratio of trunk to

limb fat assessed by DXA.

At 12 weeks trunk limb fat ratio decreased on both GH

regimes, although only the 4mg daily arm achieved

significant reduction in VAT: 9.2% in males, 13.5% in

females.

Despite total body fat decreases and greater truncal

fat loss greater than 84%, there was no overall weight

loss. Lean Body Mass increased in both GH arms (3kg in

women, 3.5kg in men on GH daily; 2.1kg, 2.8kg,

respectively on GH alternate days).

The most common adverse effects were arthralgia,

peripheral swelling, pain in limbs, parasthesia and

hyperglycemia; fasting and 120 minute glucose rose

signifantly in the GH daily arm, requiring dose

reduction in several patients. In total, 17 (17.1%)

discontinued the trial - 3 on placebo, 4 on GH

alternate days and 10 on GH daily.

Serostim has orphan drug status in the EU, where the

drug is not yet approved for any purpose, unlike the

US where GH was granted accelerated approval for AIDS

wasting in 1998. In a related late-breaker session

Graeme Moyle presented results of a Phase IV trial

using 6mg GH daily for AIDS Wasting, showing that it

was safe and relatively useful after 12 weeks of

treatment. Cost issues, however, will likely mean that

the use of GH for AIDS wasting remains rare, given the

availability of cheaper and equally effective anabolic

steroids.