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Somatonorm Post‐Marketing Surveillance Study (UK and Ireland, 1986‐1987): a Preliminary Report
Author(s) -
WILD R. N.
Publication year - 1988
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/j.1651-2227.1988.tb10807.x
Subject(s) - medicine , family medicine
A PMS study in the UK and Ireland recruited 581 children, mainly with GH deficiency, for treatment with Somatonorm and observation for 1 year; only 1 child proved totally non‐evaluable. The mean dose prescribed was 0.41 IU/kg/week, with 56% of children receiving below the recommended dose. Underdosing was reflected particularly by the low growth rates of pubertal children. Somatonorm was safe, with a low incidence of reported events, of which lipoatrophy (in 6 cases) was the most common. Antibody assays were seldom requested and always negative.