Low-dose rHGH maintains reductions in abdominal fat for 60 weeks

Although several studies have shown that recombinant Human Growth Hormone (rHGH) can reduce abdominal fat accumulation and buffalo hump, the benefits have been reported to be transitory, and to reverse when treatment is discontinued. In an oral presentation, Donald Kotler presented results from using a maintenance dose of rHGH in patients who had previously responded to rHGH in the earlier STARS trial.

This extension study randomised 127 patients to 1mg or 2mg daily maintenance therapy for 24 weeks, after having used 4mg rHGH on alternate days for at least 12 weeks. One hundred and nineteen patients completed 36-60 week follow up from start of initial rHGH treatment.

Significant reductions from the start of the STARS trial (baseline) to week 60 were found in both the 1mg and 2mg maintenance groups for trunk fat measured by DEXA scan (-1.1, -1.4 kg from 9.5 and 9.8 kg), non-HDL cholesterol (-21.2, -23.8 from 175.6 and 172.1 mg/dL), and total cholesterol (-16.9, -18.5 from baselines of 213.0 and 209.2 mg/dL); all p<0.05.

Oral glucose tolerance testing revealed no change from baseline to week 60 in insulin area under the curve. There were no between-group differences in any parameters from baseline to weeks 36 or 60 among patients who received 1mg or 2mg, nor differences in incidence of most common adverse events, except for arthralgia (5.7% on 1mg vs 12.5% on 2mg) during the 24 weeks maintenance period.

Kotler concluded that based on a more favourable safety profile, the 1mg daily r-HGH dosage merits additional investigation as a maintenance therapy for HIV patients who have benefited from abdominal fat reduction at a higher r-HGH dose.

Comment

The main difficulty with these trial results is the lack of approval of r-HGH in Europe. It is still unclear which endpoints will be accepted by the EMEA or FDA for approval of drugs that are able to change the course of lipodystrophy.

Kotler DP, Grunfeld C, Muurahainen N et al. Low-dose maintenance therapy with recombinant Human Growth Hormone sustains effects of previous rHGH treatment in HIV+ patients with excess centre fat: treatment results at 60 weeks. 11th CROI 2004, Oral Abstract 80.