David Wyatt1. 1. Department of Pediatrics, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI 53226, USA. dwyatt@mail.mcw.edu
Abstract
OBJECTIVE: To review the National Cooperative Growth Study (NCGS), a national post-marketing surveillance program for children treated with biosynthetic growth hormone (GH) products from Genentech. METHODS: Representative data are presented to summarize the extensive experience of the NCGS. This study is a multicenter, observational surveillance registry begun in 1985 in coordination with the release of the first recombinant DNA biosynthetic GH. RESULTS: After almost 20 years, data from over 47 000 patients representing 165 000 patient years have been collected. There are over 12 000 active subjects (estimated to be approximately 75% of all current patients treated with a Genentech GH product) at 435 centers, providing extensive efficacy and safety data. The GrowTrak program is a secure, user-friendly database which encourages a high level of participation by the pediatric endocrine community in the USA. Efficacy has been shown in a variety of clinical diagnoses, including isolated (IGHD) and organic growth hormone deficiency (OGHD), idiopathic short stature (ISS), and Turner syndrome. Safety monitoring of this large population has provided reassuring evidence that leukemia (de novo or relapse), extracranial nonleukemic neoplasms and central nervous system (CNS) tumor recurrence are not associated with GH therapy. A small risk of intracranial hypertension and slipped capital femoral epiphyses has been suggested, especially in children with renal disease or Turner syndrome. NCGS substudies have also provided important insights into actual clinical practice. For example, screening for renal, cardiac, or auditory comorbidities in Turner syndrome is often done less than is recommended by national guidelines (NCGS 9). Furthermore, almost 65% of children referred for short stature may be lost to follow-up before an evaluation is completed (NCGS 8). CONCLUSIONS: The NCGS has proven to be a valuable method of monitoring the safety and efficacy of biosynthetic GH. The study has attracted wide physician participation due to the data collection software used and the extensive sharing of the analyses of that data with the providers.
OBJECTIVE: To review the National Cooperative Growth Study (NCGS), a national post-marketing surveillance program for children treated with biosynthetic growth hormone (GH) products from Genentech. METHODS: Representative data are presented to summarize the extensive experience of the NCGS. This study is a multicenter, observational surveillance registry begun in 1985 in coordination with the release of the first recombinant DNA biosynthetic GH. RESULTS: After almost 20 years, data from over 47 000 patients representing 165 000 patient years have been collected. There are over 12 000 active subjects (estimated to be approximately 75% of all current patients treated with a Genentech GH product) at 435 centers, providing extensive efficacy and safety data. The GrowTrak program is a secure, user-friendly database which encourages a high level of participation by the pediatric endocrine community in the USA. Efficacy has been shown in a variety of clinical diagnoses, including isolated (IGHD) and organic growth hormone deficiency (OGHD), idiopathic short stature (ISS), and Turner syndrome. Safety monitoring of this large population has provided reassuring evidence that leukemia (de novo or relapse), extracranial nonleukemic neoplasms and central nervous system (CNS) tumor recurrence are not associated with GH therapy. A small risk of intracranial hypertension and slipped capital femoral epiphyses has been suggested, especially in children with renal disease or Turner syndrome. NCGS substudies have also provided important insights into actual clinical practice. For example, screening for renal, cardiac, or auditory comorbidities in Turner syndrome is often done less than is recommended by national guidelines (NCGS 9). Furthermore, almost 65% of children referred for short stature may be lost to follow-up before an evaluation is completed (NCGS 8). CONCLUSIONS: The NCGS has proven to be a valuable method of monitoring the safety and efficacy of biosynthetic GH. The study has attracted wide physician participation due to the data collection software used and the extensive sharing of the analyses of that data with the providers.
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