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This version published online on May 17, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2004-2543
A more recent version of this article appeared on September 1, 2005
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Submitted on December 27, 2004
Accepted on May 9, 2005

Safety of growth hormone treatment in pediatric patients with idiopathic short stature

Charmian A Quigley MBBS*, Anne M Gill MSc, Brenda J Crowe PhD, Kristen Robling MSc, John J Chipman MD, Susan R Rose MD, Judith L Ross MD, Fernando G Cassorla MD, Anne M Wolka PhD, Jan M Wit MD, PhD, Lyset TM Rekers-Mombarg PhD, and Gordon B Cutler Jr MD

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA (CAQ, AMG, BJC, KR, JJC, AMW, GBC); Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH (SRR); Thomas Jefferson University, Philadelphia, PA (JLR); Institute of Maternal and Child Research, University of Chile, Santiago, Chile (FGC); Leiden University Medical Center, Leiden, Netherlands (JMW, LTMR-M)

* To whom correspondence should be addressed. E-mail: qac{at}lilly.com.

Context. Recombinant human growth hormone (GH) was approved by the United States Food and Drug Administration in 2003 for treatment of idiopathic short stature (ISS). However, to date, the safety of GH in this patient population has not been rigorously studied.

Objective. To address the safety of GH treatment in children with ISS, in comparison with GH safety in patient populations for which GH has been approved previously - Turner syndrome (TS) and GH deficiency (GHD).

Design/Setting. Rates of serious adverse events (SAEs) as well as adverse events (AEs) of particular relevance to GH-treated populations were compared across the 3 patient populations among 5 multi-center GH registration studies.

Patients. Children with ISS, TS or GHD

Intervention. GH doses ranging from 0.18 to 0.37 mg/kg/wk.

Main Outcome Measures. Rates of SAEs and AEs of special relevance to patients receiving GH. Laboratory measures of carbohydrate metabolism for ISS studies.

Results. Within the ISS studies, comprising one double-blind, placebo-controlled study and one open-label, dose-response study, SAEs (mainly hospitalizations for accidental injury or acute illness unrelated to GH exposure) were reported for 13% to 14% of GH-treated patients. Overall AE rates (serious and non-serious), as well as rates of potentially GH-related AEs, were similar in the GHD, TS, and ISS studies (for ISS studies combined: otitis media 8%, scoliosis 3%, hypothyroidism 0.7%, changes in carbohydrate metabolism 0.7%, hypertension 0.4%). Measures of carbohydrate metabolism were not affected by GH treatment in patients with ISS. There was no significant GH effect on fasting blood glucose in either study (GH dose range: 0.22 to 0.37 mg/kg/wk) or on insulin sensitivity (placebo-controlled study only).

Conclusion. Although GH appears safe in ISS, the studies were not powered to assess the frequency of rare GH-related events, and longer-term follow-up of GH-treated patients with ISS is warranted.
Key words: idiopathic short stature • human growth hormone • safety • Turner syndrome • growth hormone deficiency




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