Effects of Once-Weekly Sustained-Release Growth Hormone: A Double-Blind, Placebo-Controlled Study in Adult Growth Hormone Deficiency

Biller, Beverly M. K.; Ji, Hyi-Jeong; Ahn, Hyung Taek; Savoy, Conrad; Siepl, E. Christine; Popović, Vera; Coculescu, Mihail; Roemmler, J.; Gavrila, Catalin; Cook, David M.; Strasburger, Christian J.

doi:10.1210/jc.2010-2819

Cited by 49 publications

(29 citation statements)

References 23 publications

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“…In recent years, safety and efficacy of several sustained-release GH formulations with once a week administration have been evaluated [36,37]. Hence, preparation of long-acting GH formulations can offer a significant improvement in adherence [38].…”

Section: Discussionmentioning

confidence: 99%

Adherence to growth hormone therapy in children and its potential barriers

Mohseni

Heydari

Qorbani

et al. 2017

Journal of Pediatric Endocrinology and Metabolism

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Background: One of the main concerns in chronic diseases such as growth hormone (GH) deficiency is adherence to the treatment, which significantly affects treatment outcomes. Methods: This cross-sectional study was conducted among 169 GH recipient children (2-12 years) and teens (13-19 years) referred to a GH distributing teaching pharmacy. The eight-item Morisky Medication Adherence Scale (MMAS) and auto-compliance method were used for the assessment of patients' adherence to GH. The potential barriers to GH therapy adherence and medication persistence were also explored. Results: Based on the MMAS method, 56.7% of the children and 57.9% of the adolescent groups were adherent to GH therapy. Conversely, according to the auto-compliance method almost all the patients were adherent in the children (95.2%) and adolescent (95.5%) groups. Forgetting to take the injection or refill the prescription, being away from home, exhaustion from long-term injection, drug shortage and inaccessibility to the pharmacy were barriers found to be significantly associated with a low adherence in the children group. While in the adolescent group, forgetting to take the injection, painful injection, concern about longterm complications and exhaustion from long-term injection revealed a significant association with low adherence. Persistence with GH therapy was reported in 75.3% and 67% of children and adolescent patients, respectively.

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Section: Discussionmentioning

confidence: 99%

Adherence to growth hormone therapy in children and its potential barriers

Mohseni

Heydari

Qorbani

et al. 2017

Journal of Pediatric Endocrinology and Metabolism

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“…The lack of daily variations in GH levels when long acting preparations are administered has been speculated to result in supraphysiological IGF-I levels, which theoretically could increase the risk of malignancies and of an adverse metabolic profile. However, in the studies performed until now similar IGF-I levels and no major negative effects on glucose metabolism have been observed [46,47,50]. In this context it is probably also important to realise that once daily injections of GH are not physiological either.…”

Section: New Perspectivesmentioning

confidence: 92%

Growth hormone replacement in adults – current standards and new perspectives

Höybye

Christiansen

2015

Best Practice & Research Clinical Endocrinology & Metab

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“…The pharmacokinetic and pharmacodynamic profile of LB03002 has been established in both children and adults with GH deficiency (GHD) (6,7). Preliminary efficacy and safety results from studies on GH-deficient children and adults have shown LB03002 to be a suitable candidate for long-term replacement therapy in patients with GHD (8,9). In this study, the primary objective was to evaluate the longterm efficacy and safety of LB3002 compared with daily rhGH treatment for 12 months.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency

Hwang

Lee

Chung

et al. 2013

European Journal of Endocrinology

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Purpose: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustainedrelease human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD). Methods: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period. Results: The mean (S.D.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HV at 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events. Conclusion: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.

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Effects of Once-Weekly Sustained-Release Growth Hormone: A Double-Blind, Placebo-Controlled Study in Adult Growth Hormone Deficiency

Abstract: Weekly GH replacement with the sustained-release preparation LB03002 in adults significantly reduced FM over 6 months and was well tolerated.

Cited by 49 publications

References 23 publications

Adherence to growth hormone therapy in children and its potential barriers

Adherence to growth hormone therapy in children and its potential barriers

Growth hormone replacement in adults – current standards and new perspectives

Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency

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