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Somatonorm post-marketing surveillance study (UK and Ireland, 1986-1987): a preliminary report
1Medical Department, KabiVitrum Ltd, Uxbridge, Middlesex, UK.
Insights
This study found that Somatonorm was safe for treating growth hormone deficiency in children. However, many children received underdosing, particularly impacting pubertal children's growth rates.
Area of Science:
- Pediatrics
- Endocrinology
- Pharmacovigilance
Background:
- Growth hormone (GH) deficiency affects children's growth.
- Somatonorm is a treatment option for GH deficiency.
Purpose of the Study:
- To assess the safety and effectiveness of Somatonorm in a real-world setting.
- To evaluate treatment adherence and identify potential issues like underdosing.
Main Methods:
- A post-marketing surveillance (PMS) study.
- Recruited 581 children in the UK and Ireland.
- Observed children for 1 year during Somatonorm treatment.
Main Results:
- Only 1 child was non-evaluable.
- Mean prescribed dose was 0.41 IU/kg/week; 56% received underdosing.
- Underdosing particularly affected pubertal children's growth rates.
- Somatonorm demonstrated a good safety profile with low adverse events; lipoatrophy was most common (6 cases).
- Antibody assays were rarely requested and consistently negative.
Conclusions:
- Somatonorm is safe for pediatric GH deficiency treatment.
- Underdosing is a concern, potentially impacting treatment efficacy, especially in pubertal children.
- Real-world data supports Somatonorm's safety and highlights the need for appropriate dosing.
Abstract:
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.