KIGS - How it all started
Growth hormone (GH) has been in clinical use for more than 40 years. Treatment with GH was initially based on pituitary-derived human GH, and owing to the relative scarcity of the product, was limited to children with severe growth hormone deficiency (GHD). The increased availability of recombinant GH through the introduction of recombinant GH in 1985 permitted greater numbers of patients to receive GH therapy and made it possible to conduct trials aimed at optimising treatment modalities in children with less severe forms of impaired GH secretion. At the same time, the limited knowledge of the long-term effects of recombinant GH, together with the increasing number of patients treated, led health authorities in Germany, UK, Sweden and several other countries to request long-term follow-up in a large cohort of patients. KIGS (Pfizer International Growth Database) was therefore initiated in December 1987 with the main objective of documenting long-term efficacy and safety of recombinant GH (Pfizer Inc. US) in children receiving GH as a prescribed drug.
The first objective of KIGS was to enrol a large patient group of 500 children to be followed over a period initially set at 5 years. This goal was revised several times during 1988 and 1989 because of the great interest in the project. The number of patients more than tripled during the 1st year, and the number of participating countries increased from three to ten. It was then decided not to limit the number of patients enrolled, but to open the KIGS database to all patients treated with GH from Pfizer as a prescribed drug. The period of follow-up was at the same time increased to cover the whole treatment period from start of GH treatment to near adult height.
KIGS today contains a unique collection of data on patients treated with recombinant GH and has grown from the first relatively simple conception to the present complex project.
KIGS has continued to expand over 25 years and as of January 2013, the total KIGS database comprised >83 000 patients from 52 countries.
In October 2012, the KIGS database ceased collecting further data as the cumulative quantity available was considered to be substantial and robust; therefore, KIGS was transitioned to a static database.