Efficacy and Tolerability of an Individualized Dosing Regimen for Adult Growth Hormone Replacement Therapy in Comparison with Fixed Body Weight-Based Dosing

    loading  Checking for direct PDF access through Ovid


To determine whether an individualized dose titration regimen (ID) for adult GH replacement therapy would have similar efficacy and better tolerability than a fixed body weight-based dosing regimen (FD), 387 adults with GH deficiency were randomized to FD (n = 200) or ID (n = 187) for 32 wk. In FD, subjects received sequentially 4, 8, and 12 μg/kg·d GH. ID was started at 0.2 mg/d and increased by 0.2-mg/d increments, based on clinical and serum IGF-I responses, to a maximum of 0.8 mg/d. Increases (mean ± sd) in serum IGF-I were similar in both groups (FD, 110.2 ± 87.8 vs. ID, 99.6 ± 77.7 μg/liter, P = 0.20) despite higher final GH doses in FD (0.70 ± 0.32 vs. 0.54 ± 0.22 mg/d, P < 0.001). Favorable changes in several efficacy measures were observed with no significant differences between the FD and ID groups: lean body mass increased; health-related quality of life improved; and abdominal fat mass, hip circumference, sum of skinfolds, and total and low-density lipoprotein cholesterol decreased. The decrease in fat mass was greater with FD than ID for men (−2.7 ± 2.7 kg vs. −1.8 ± 2.5 kg, P = 0.04) but not for women (−2.1 ± 2.4 vs. −2.0 ± 3.8 kg). The change in waist circumference was greater with FD than ID for women but not for men. There was a significant reduction of systolic blood pressure in ID but not in FD. The adverse event profile was similar between FD and ID except that ID had a lower occurrence of peripheral edema (9.1% vs. 16.5%, P = 0.03) and rash (1.1% vs. 5.5%, P = 0.02) than FD. In summary, the use of ID resulted in improved tolerability and similar efficacy compared with FD. We conclude that GH replacement therapy should be initiated at a low dose and titrated to a dose producing maximal benefits without adverse side effects and an IGF-I level within the age- and sex-adjusted normal range.

Related Topics

    loading  Loading Related Articles