Serono-Serono's Serostim [somatropin (rDNA origin) for injection] administered daily decreased visceral adipose tissue in patients with HIV-associated adipose redistribution syndrome (HARS), according to study data published in the current edition of the Journal of AIDS.
Some people with AIDS or HIV infection develop HARS or HIV-associated adipose redistribution syndrome, an excessive build up of visceral adipose tissue combined with metabolic abnormalities. No medical treatment is currently approved to treat HARS.
"While further study is needed, Serostim is a potential treatment for visceral fat accumulation in patients with HARS," said Donald Kotler, St. Luke's Roosevelt Hospital, New York, and a lead investigator in the study.
The Serostim in the treatment of adipose redistribution syndrome (STARS) trial was a multi-centre, randomized, double-blind, placebo-controlled study that included 239 patients at sites located throughout the US. The study was designed to evaluate the efficacy and safety of Serostim therapy at doses of 4 mg daily/ every other day for a period of 12 weeks as treatment of abnormal visceral adipose tissue accumulation in HIV-infected patients with HARS.
The results showed that the decrease in visceral adipose tissue was highly significant in the Serostim 4 mg daily group as compared to placebo. The study also showed that the "trunk to limb fat ratio," another measure of fat distribution, was significantly reduced in both the Serostim 4 mg daily and alternate day groups compared to placebo.
Among the study's secondary endpoints was an evaluation of serum total and non-HDL cholesterol which declined significantly in both the Serostim 4 mg daily and alternate day dose groups compared to the placebo group.
Adverse reactions reported during this clinical trial were consistent with those expected within the current approved indication for Serostim.
HARS is a subset of HIV lipodystrophy. HIV-associated lipodystrophy is characterized by a variety of metabolic disturbances and body shape abnormalities that may present individually or in combination.
Patients with HARS experience abnormal, pathological accumulation of adipose tissue, which may be present with or without fat depletion and/or metabolic abnormalities. In general, HARS patients accumulate excess visceral adipose tissue in the abdomen or may develop a fat pad on the upper back commonly known as a "buffalo hump."
Serostim is the only growth hormone approved by the US FDA for the treatment of HIV wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6 mg/day for patients > 55 kg). Serostim 0.1 mg/kg every other day should be considered as a starting dose in patients thought to be at risk of certain adverse effects, i.e., glucose intolerance.
In patients with HIV-associated wasting, Serostim has a manageable side effect profile. The most common adverse events associated with Serostim therapy are mild to moderate muscle and joint pain and swelling, which occur in a dose-related manner and often subside with continued treatment or dose reduction. Cases of new onset impaired glucose intolerance, new onset Type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus have been reported in patients receiving Serostim. Some develop diabetic ketacidosis and diabetic coma. In some patients, therapy with Serostim necessitated initiation or adjustment of anti-diabetic treatment.
Use of growth hormone is contraindicated in treatment of patients in intensive care units due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma or acute respiratory failure; patients with active neoplasia; and patients with known hypersensitivity to growth hormone. Serostim must be used in conjunction with antiretroviral therapy.