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DGDispatch
Recombinant Human Growth Hormone Improves Body Composition in Adults with Growth Hormone Deficiency: Presented at ECE
By Alison Palkhivala
LYON, FRANCE -- April 29, 2003 -- Use of recombinant human growth hormone in adults with growth hormone deficiency increases lean body mass and decreases fat mass, according to a randomised trial.
Dr. Rolf-Christian Gaillard, from the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and colleagues from the Adult Growth Hormone Deficiency (AGHD) Study Group performed a two-phase clinical trial examining the effects of recombinant human growth hormone on body composition in adults with growth hormone deficiency.
Dr. Gaillard presented the results in a poster here on April 29th at the 6th European Congress of Endocrinology.
For the first phase of the trial, 115 adults who had acquired or idiopathic growth hormone deficiency for at least 2 years were randomised to treatment with the recombinant human growth hormone SaizenŽ 0.005 to 0.010 mg/kg/day or a placebo for 6 months. In the second, open-label phase of the study, 111 patients of the original 115 patients took recombinant human growth hormone 0.005 mg/kg/day for the first month and 0.010 mg/kg/day thereafter for an additional 30 months.
Overall, 100 patients completed 6 months of therapy, 78 completed 12 months, 48 completed 18 months, 27 completed 24 months, 19 completed 30 months and six completed 36 months.
The authors presented data on up to 18 months of therapy. After 6 months of therapy, patients receiving recombinant human growth hormone had significant increases in lean body mass compared with patients taking placebo (1.90 vs. -0.25 kg, respectively, P<0.0001). This increase was significantly higher in men than women (2.97 vs. 1.19 kg, respectively, P<0.0001). This change was maintained through 18 months of observation.
Similarly, after 6 months of therapy, patients on active treatment experienced significant decreases in total fat mass compared with those on placebo (-2.30 vs. 0.47 kg, respectively, P<0.0001). Again, this effect was more pronounced in men than women (-3.26 vs. -1.63 kg, respectively, P<0.0001). Changes in fat mass persistent through 18 months of therapy.
Neither body weight nor body mass index changed significantly in either group throughout 18 months of therapy.
Overall, therapy was well tolerated, with the most common side effects being arthralgia, myalgia, peripheral oedema and paresthesia. Most often, these were mild or moderate in severity. Only 23 patients discontinued active treatment.
In their poster, the authors concluded that, long-term replacement therapy with recombinant human growth hormone in adults with growth hormone deficiency results in a sustained favourable change in body composition, with increased lean body mass and reduced fat mass. These effects, they stated, a greater effect is seen in men than in women.
[Study title: Sustained Beneficial Effects Of Recombinant Human Growth Hormone On Body Composition In Adult Growth Hormone Deficiency. Abstract P0836.]
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