In November 2007, the SAGhE project was proposed to the European Community (EC) for funding by the seventh frame work program (FP7) under one of the general objectives of the FP7 which is to promote the “better use of medicines” by European citizens. Eight countries were involved in the project which has been accepted by FP7.

On June 1^st, 2009, SAGhE has officially started in Europe.

Background

Recombinant growth hormone (GH) has been used worldwide since 1985. Current indications for GH use in children include GH deficiency and an increasing number of conditions where childhood short stature is not primarily due to deficient GH secretion.

Approximately 40 000 children in the EU are treated with daily injections of GH. The efficacy of GH to increase adult height is undisputed in children with severe GH deficiency but is more limited in other indications where current estimates suggest a gain of about 1 cm of adult height per year of treatment. The clinical significance of height gains has been poorly evaluated.

The possibility has been raised that GH use in childhood might increase the risk of malignancy later in life. However, little data is available to further explore this concern.

What is SAGhE?

SAGhE is an integrated consortium of paediatric endocrinologist, epidemiologists and biostatisticians that will collect and analyse data to address the questions of appropriateness and safety of childhood GH treatments. The impact of GH use on height and psychosocial components will be evaluated in a large unbiased metacohort of patients followed to adult height. Safety will be evaluated by analysing long term mortality and long term cancer incidence. The data will then be integrated and disseminated to several levels of users. SAGhE will contribute to the aims of the FP7 Health work programme and to the new Community Action programme of public Health in the field of better use of medicines. The size and design of the study, the independence and thorough data analysis will allow its translation into evidence-based guidelines and the implementation of evidence-based medicine in Europe. SAGhE will be comprehensive at the EU level and will test for national differences. It will address patient safety, one of the key points of the work programme.

SAGhE is unique worldwide in its design, size and potential to answer important questions raised on childhood GH treatments.

Expected number of patients: about 30 000

Participant countries: Belgium, France, Germany, Italy, Netherlands, Sweden, Switzerland, United Kingdom.

Duration of the study: 3 years Start: June 1^st 2009 End : May 31 2012

SAGhE contributes to the aims of the FP7 Health work programme and to the new Community Action programme of public Health in the field of better use of medicines.