Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study (Preprint)

BACKGROUND Adherence to growth hormone therapy is difficult to detect reliably. Devices such as easypod have been developed for electronic recording of injections. The easypod connect observational study (ECOS) was an open-label, observational, multinational, phase IV study conducted in 24 countries around the world. The final results from ECOS in the Taiwanese cohort are reported in this paper. OBJECTIVE This study aimed to evaluate the adherence and long-term outcomes of growth hormone therapy in pediatric subjects using the easypod electromechanical device. METHODS Subjects (aged 2-18 years or >18 years without fusion of growth plates) who received Saizen (recombinant human growth hormone, somatropin) via the easypod device were enrolled in this study. The primary objective was to assess the level of adherence in subjects receiving Saizen via easypod. RESULTS In Taiwan, a total of 35 and 13 children fulfilled the criteria of full analysis set and complete analysis set, respectively. The mean (SD) age of the complete analysis set was 12.08 (2.72) years. All subjects were growth hormone–naïve, with 38% (5/13) females. The mean adherence rates of 13 subjects were 87.6% at 3 months and 84.3% at 6 months, that of 8 subjects was 81.0% at 9 months, and that of 4 subjects was 91.6% at 1 year. After 1 year of treatment, subjects had a median (Q1:Q3) change in height SD score of 0.30 (0.06:0.48), median height velocity of 6.50 (4.33:8.24) cm/year, and median change in height velocity SD score of 1.81 (–0.04:3.52). CONCLUSIONS With the easypod device, patients with inadequate adherence and poor response to treatment can be identified. Adherence to growth hormone therapy administered via easypod was generally high in the first year of treatment but the adherence gradually decreased over time. Overall, growth outcomes after 1 year indicated a positive growth response to growth hormone treatment. Future efforts should be focused on personalized management of adherence by using the easypod system.

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Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study

JMIR Pediatrics and Parenting ◽

10.2196/14774 ◽

2021 ◽

Vol 4 (1) ◽

pp. e14774

Author(s):

Pen-Hua Su ◽

Chen Yang ◽

Mei-Chyn Chao ◽

Chung-Lin Chiang

Keyword(s):

Growth Hormone ◽

Observational Study ◽

Hormone Therapy ◽

Growth Hormone Therapy ◽

Recombinant Human Growth Hormone ◽

Height Velocity ◽

Complete Analysis ◽

Adherence Rate ◽

Growth Outcomes ◽

The Mean

Background Adherence to growth hormone therapy is difficult to detect reliably. Devices such as easypod have been developed for electronic recording of injections. The easypod connect observational study (ECOS) was an open-label, observational, multinational, phase IV study conducted in 24 countries around the world. The final results from ECOS in the Taiwanese cohort are reported in this paper. Objective This study aimed to evaluate the adherence and long-term outcomes of growth hormone therapy in pediatric subjects using the easypod electromechanical device. Methods Subjects (aged 2-18 years or >18 years without fusion of growth plates) who received Saizen (recombinant human growth hormone, somatropin) via the easypod device were enrolled in this study. The primary objective was to assess the level of adherence in subjects receiving Saizen via easypod. Results In Taiwan, a total of 35 and 13 children fulfilled the criteria of full analysis set and complete analysis set, respectively. The mean (SD) age of the complete analysis set was 12.08 (2.72) years. All subjects were growth hormone–naïve, with 38% (5/13) females. The mean adherence rates of 13 subjects were 87.6% at 3 months and 84.3% at 6 months, that of 8 subjects was 81.0% at 9 months, and that of 4 subjects was 91.6% at 1 year. After 1 year of treatment, subjects had a median (Q1:Q3) change in height SD score of 0.30 (0.06:0.48), median height velocity of 6.50 (4.33:8.24) cm/year, and median change in height velocity SD score of 1.81 (–0.04:3.52). Conclusions With the easypod device, patients with inadequate adherence and poor response to treatment can be identified. Adherence to growth hormone therapy administered via easypod was generally high in the first year of treatment but the adherence gradually decreased over time. Overall, growth outcomes after 1 year indicated a positive growth response to growth hormone treatment. Future efforts should be focused on personalized management of adherence by using the easypod system.

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Effects of recombinant human growth hormone therapy on carbohydrate, lipid, and protein metabolisms of children with Turner syndrome

Pakistan Journal of Medical Sciences ◽

10.12669/pjms.304.4546 ◽

2014 ◽

Vol 30 (4) ◽

Cited By ~ 1

Author(s):

Weibin Qi ◽

Shuxian Li ◽

Qiong Shen ◽

Xiuxia Guo ◽

Huijuan Rong

Keyword(s):

Growth Hormone ◽

Hormone Therapy ◽

Turner Syndrome ◽

Human Growth Hormone ◽

Growth Hormone Therapy ◽

Recombinant Human Growth Hormone ◽

Human Growth

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Effects of recombinant human growth hormone therapy in adults with Prader-Willi syndrome: a meta-analysis

Clinical Endocrinology ◽

10.1111/j.1365-2265.2011.04303.x ◽

2012 ◽

Vol 77 (1) ◽

pp. 86-93 ◽

Cited By ~ 45

Author(s):

Ruth Sanchez-Ortiga ◽

Anne Klibanski ◽

Nicholas A. Tritos

Keyword(s):

Growth Hormone ◽

Hormone Therapy ◽

Human Growth Hormone ◽

Growth Hormone Therapy ◽

Meta Analysis ◽

Recombinant Human Growth Hormone ◽

Human Growth ◽

Prader Willi Syndrome

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Effect of One-Year Growth Hormone Therapy on Cardiometabolic Risk Factors in Boys with Obesity

BioMed Research International ◽

10.1155/2020/2308124 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Jing Wu ◽

Fei Zhao ◽

Yuan Zhang ◽

Jiang Xue ◽

Jiangying Kuang ◽

...

Keyword(s):

Growth Hormone ◽

Hormone Therapy ◽

Human Growth Hormone ◽

Growth Hormone Treatment ◽

Growth Hormone Therapy ◽

Recombinant Human Growth Hormone ◽

Human Growth ◽

Hormone Treatment ◽

Risk Markers ◽

One Year

It has been recognized that people with obesity are more likely to have low growth hormone secretion. Recent studies have also confirmed that the abnormalities of the growth hormone/insulin-like growth factor 1 axis were associated with cardiovascular complications in people with obesity. However, little is known about whether recombinant human growth hormone therapy could improve cardiovascular and metabolic risks in obese children. This study aims to evaluate the effect of one-year growth hormone therapy on obesity-related comorbidities and to assess the safety in Chinese boys with obesity. Eighteen boys with obesity were treated with recombinant human growth hormone for one year. Anthropometric measurements, endocrine testing, and cardiovascular risk markers were performed in all obese boys in baseline, and follow-up visits were performed at 3 months, 6 months, 9 months, and one year, respectively. After one year of recombinant human growth hormone treatment, the body mass index standard deviation scores decreased (P<0.001) and insulin-like growth factor 1 levels increased (P<0.001). GH treatment also reduced low density lipoprotein cholesterol (P<0.001), total cholesterol (P<0.001), triglycerides (P=0.042), and alanine aminotransferase (P=0.027) when compared with the baseline. One-year of recombinant human growth hormone treatment could improve cardiometabolic risk markers, without adverse effects on glucose homeostasis in boys with obesity.

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