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PEDIATRICS Vol. 104 No. 4 Supplement October 1999, pp. 1028-1031

Growth Hormone Stimulation Test Results as Predictors of Recombinant Human Growth Hormone Treatment Outcomes: Preliminary Analysis of the National Cooperative Growth Study Database

Received May 13, 1999; accepted Jun 22, 1999.

George M. Bright*, Joanne R. JuliusDagger , John Lima*, and Sandra L. BlethenDagger

From the * Department of Pediatric Endocrinology and the Center for Pharmacokinetic and Pharmacodynamic Research, Nemours Children's Clinic, Jacksonville, Florida; and Dagger  Medical Affairs, Genentech, Inc, South San Francisco, California.

Growth hormone (GH) stimulation tests are considered a prerequisite to clinical trials of recombinant human GH (rhGH) therapy, but the test results may not be predictive of the treatment outcomes with rhGH. We examined the GH stimulation test results as a predictor of the treatment outcome in a cohort of prepubertal subjects in the National Cooperative Growth Study. A standard is proposed in which a diagnosis of GH deficiency is considered appropriate when a patient has significant first-year catch-up growth and that a positive stimulation test result predicts this outcome. With this construct, a traditional interpretation of GH stimulation test results correctly identifies 64% of the rhGH treatment outcomes. The analysis shows an upper limit of diagnostic sensitivity of 82% and a lower limit of specificity of 25% in our study population. The results of our recent studies suggest that the sensitivity and specificity of the current GH stimulation tests are attributable in part to broad intersubject variation in GH clearance, rates of GH elimination, and GH volume of distribution. The combined studies suggest that the use of subject-specific pharmacokinetic parameters will improve the diagnostic interpretation of GH stimulation test results and improve rhGH treatment outcomes.growth hormone stimulation tests, recombinant human growth hormone, pharmacokinetic parameters, maximal stimulated growth hormone concentration.

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