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The Pharmacokinetic and Pharmacodynamic Characteristics of a Long-Acting Growth Hormone (GH) Preparation (Nutropin Depot) in GH-Deficient Adults

2002; Oxford University Press; Volume: 87; Issue: 10 Linguagem: Inglês

10.1210/jc.2002-020480

1945-7197

David M. Cook, Beverly M. K. Biller, M. L. Vance, Andrew R. Hoffman, L S Phillips, Kathleen Ford, David P. Benziger, Ari Illeperuma, Sandra L. Blethen, Kenneth M. Attie, Le N. Dao, James D. Reimann, Paul J. Fielder,

Adrenal Hormones and Disorders

A pharmacokinetic-pharmacodynamic study of a long-acting GH [Nutropin Depot; somatropin (rDNA origin) for injectable suspension] was performed in 25 patients with adult GH deficiency. Single doses of 0.25 mg/kg and 0.5 mg/kg, based on ideal body weight, were administered sc. After either dose, serum GH concentrations rose rapidly in both sexes. In men, the lower dose maintained serum IGF-I levels within 1 sd of the mean for age and sex for 14–17 d; the higher dose raised IGF-I levels 2 sd above the mean. In most women, all of whom were receiving oral estrogen, the lower dose did not normalize IGF-I levels; the higher dose maintained IGF-I near the mean for approximately 14 d. Increases in IGF binding protein-3 and acid-labile subunit levels were observed in both sexes; however, a sex-related difference was not obvious. Fasting glucose and insulin concentrations were transiently elevated in men receiving the higher dose. Patients tolerated the injections well. We concluded that a single injection of Nutropin Depot at these doses in patients with adult GH deficiency increased serum IGF-I to within normal limits for 14–17 d. Estrogen-treated women required approximately twice the dose needed in men to produce comparable IGF-I concentrations.