Background: The weekly sustained-release growth hormone (GH) has been approved for treatment in growth hormone deficiency (GHD). It provides a practical strategy for improving adherence.
Objective and hypotheses: To evaluate the long-term safety and effectiveness of two formulations of daily (Eutropin®) and weekly (EutropinPlus®) GH in Korean pediatric GHD patients.
Method: A multicenter, long-term, prospective and retrospective study. Statistical analysis has been conducted annually using a pre-defined method. The interim analysis was conducted in all patients who were enrolled from Jan 2012 to Mar 2016.
Results: Total 901 patients with GHD were analysed to compare the safety during the 4 years of GH treatment (daily (n=647), weekly (n=254)). And for effectiveness, 619 patients were analysed (daily (n=444), weekly (n=175)). Baseline demographics were similar between groups except age (Chronological age: 8.01 vs 9.05, Bone age: 6.36 vs 7.41 years, respectively). For daily vs. weekly GH group, Height SDS was −2.4 vs −2.5 at baseline. ΔHeight SDS during the first year of GH treatment was 0.67 vs 0.56 which was statistically different between groups but there was no statistical difference between groups when sub-analysed by <8 and ≥8 years. Height Velocity (HV) at the first year was 8.98 and 8.71 cm/year in the daily and weekly with no statistical difference, and same trend was showed during 4 years treatment. Adverse events (AEs) were reported in 18.4 vs 16.9% of patients in the daily vs weekly, and mostly reported as mild. The incidence of adverse drug reactions was 3.7 and 4.7%, respectively.
Conclusion: Growth response of weekly GH is comparable that of daily GH in GHD. Also, weekly GH showed a similar profile to daily GH formulation without special safety concerns when used in GHD patients for 4 years.
10 Sep 2016 - 12 Sep 2016