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Short-Term Safety and Efficacy of Human GH Replacement Therapy in 595 Adults with GH Deficiency: A Comparison of Two Dosage Algorithms

Lilly Research Centre (A.K., P.C.B., P.F., M.B., P.M., A.F.A.), Erl Wood Manor, Windlesham, Surrey GU20 6PH, United Kingdom; Eli Lilly \|[amp ]\| Co. (W.F.B.), Bad Homburg, D-61350 Germany; Mount Sinai Hospital (S.E.), Toronto, M5G 1X5 Canada; Garvan Institute (K.K.Y.H.), Darlinghurst, Sydney, NSW 2010, Australia; Frederico II University (G.L.), Naples, 80131 Italy; University Hospital (A.L.), A-1090 Vienna, Austria; University Hospital (J.M.), 128 01 Prague 2, Czech Republic; and St. Thomas Hospital (D.R.-J., P.S.), London SE1 7EH, United Kingdom

Address all correspondence and requests for reprints to: Dr. Anne Kehely, Lilly Research Centre, Erl Wood Manor, Sunninghill Road, Windlesham, Surrey GU20 6PH, United Kingdom. E-Mail: . Kehely_Anne{at}Lilly.com

Abstract

The aim of GH replacement therapy in GH-deficient adults is to optimize response with minimum incidence of adverse reactions, but optimal therapy regimens are still to be established. This two-arm parallel study examined effects of two GH dose algorithms in adults with GH deficiency of adult or childhood onset. Patients on low dose (LD; n = 302) received GH at 3 µg/kg per day for 3 months increasing to 6 µg/kg per day for 3 months, and those on conventional dose (CD; n = 293) started on 6 µg/kg per day for 3 months increasing to 12 µg/kg per day for 3 months. The proportion of patients completing therapy was greater for the LD group than the CD group for the first 3 months (93.0% vs. 88.1%; P = 0.037) and overall for the 6 months (90.7% vs. 84.0%; P = 0.013). Both dose groups showed significant increases in lean body mass and decreases in fat mass for all time points. Percent increase in lean body mass was less with LD than CD over the first 3 months (2.43 ± 4.33 vs. 3.58 ± 4.69%; P = 0.006) but not overall for the 6-month period (4.38% ± 5.34% vs. 5.21% ± 5.99%; P = 0.141). Percent decrease in fat mass was less with LD than CD for the first 3 months (-2.81% ± 7.81% vs. -5.53% ± 8.64%; P < 0.001) and overall for the 6-month period (-6.35% ± 9.42% vs. -9.45% ± 12.07%; P = 0.006). IGF-I SD score increased less with LD than CD for 0 to 3 and 0 to 6 months, although for IGF-binding protein-3 SD score, there was no significant difference between doses at any time. Arthralgia was the only adverse event that occurred significantly less frequently with LD than with CD. Calculated changes based on gender and onset indicated greater changes in males than females for body composition, but there was little difference in GH-related adverse events between males and females. The lower starting dose with dose titration appeared more favorable, but differences in response between genders and onset of GH deficiency need to be taken into account when setting an individual dose regimen.

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