FIRST YEAR RESULTS OF FRENCH COLLABORATIVE STUDY IN PREPUBERTAL I.G.H.D. PATIENTS TREATED WITH TWO DOSES OF GRANDITROPIN (liquid r-hGH)

L.DI NICOLA¹, J.L.CHAUSSAIN², M.CHAUSSAIN², C.GENDREL¹, N.LE DREN¹, P.RYZIGER¹

1 Grandis Biotech France SA, 2 (On behalf of the French Investigators' Group) St Vincent de Paul Hospital" Division of Paediatric Endocrinology " PARIS

91 Prepubertal I.G.H.D., 41 girls and 50 boys are treated during 12 months with 2 doses of Granditropin^Ò 5 mg (15 IU) r-hGH liquid formulation filled in cartridges 1,5 ml administrated with GrandiPen^Ò.

Objective

In our study, we evaluated the impact of two doses of Granditropin^Ò on the Growth Velocity and on the H.S.D.S.

Group A received 0,23 mg (0,7 IU)/Kg/W and Group B 0,46 mg (1,4 IU)/Kg/W during 12 months. After this period Group B was treated with the same dose as Group A for a 5-year follow up period.

Patients and Therapy

91 Prepubertal I.G.H.D. patients with growth retardation ³ -2,0 S.D.S (proved by 2 pharmacological stimulation tests and hGH serum concentration <10 mg/ml) were included in the GranditropinÒ French Dose–Response Collaborative Study. Both groups were similar in terms of population (50 boys and 41 girls) as well as for Chronological Age (Group A : C.A 9,3 ± 2,2 and Group B : 9,0 ± 2,7). Group A was treated with 0,23 mg/Kg/W and Group B was treated with 0,46 mg/Kg/W of Granditropin^Ò (r-hGH) liquid formulation filled in cartridges 1,5 ml administrated with GrandiPen^Ò.

Results

		Growth Velocity (cm/y)		H.S.D.S
Group (n=91)	C.A.(Years)	T=0	T=12	T=0	T=12	DH.S.D.S
A (n=44)	9,3 ± 2,2	3,8 ± 0,9	9,6 ± 1,7	-2,4 ± 0,5	-1,5 ± 0,5	0,9 ± 0,4
B (n=47)	9,0 ± 2,7	4,2 ± 1,2	11,5 ± 2,0	-2,3 ± 0,5	-1,1 ± 0,6	1,2 ± 0,5
			p<0,001			p<0,001

Conclusion

From the results reported after 12 months therapy with liquid Granditropin^Ò, we note a significant difference between average gain in Growth Velocity and H.S.D.S. at month 12 between group A and group B (p<0,001 for Growth velocity and p<0,001 for H.S.D.S.) However, a long-term follow-up period will be requested to demonstrate the beneficial effect of the two different doses in the first year therapy. For the metabolic parameters, no significant difference was reported between the two groups. IGF-1 level was high in group B but not very different from A.

2462