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Precis Future Med > Volume 7(3); 2023 > Article |
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AUTHOR CONTRIBUTIONS
Conception or design: AY.
Acquisition, analysis, or interpretation of data: AY.
Drafting the work or revising: AY.
Final approval of the manuscript: AY.
South Korea | United States FDA | GH Research Society [11] | |
---|---|---|---|
Age of treatment initiation | Reimbursement for ages 2 and above | Unspecified age reimbursement | No consensus on rhGH start age, but agreed on benefits of treating before obesity onset, often by age 2 |
Duration of treatment | Stop in children with <1 cm growth rate & before epiphyseal closure | Stop in children with almost closed epiphyses | Until reaching an adult height or near adult height |
Dosage | 0.24 mg/kg/week | 0.24 mg/kg/week | Initial dose: 0.5 mg/m2/day, adjustable to approximately 1 mg/m2/day |
Approved somatropin injection | Genotropin (approved Mar. 2004) | Genotropin (approved Jun. 2000) | |
Scitropin Aa) | Omnitropea) | ||
Eutropin (approved Dec. 2019) | |||
Contraindications for PWS | Severe obesity or severe respiratory disorders | Severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection | Severe obesityb), uncontrolled diabetes, untreated severe obstructive sleep apnea, active cancer, and active psychosis |
Study | Study design | Mean age at GH start | No. of patients (female %) | GHT duration | GH dose | Country/Ethnicity | Outcomes |
---|---|---|---|---|---|---|---|
Hauffa (1997) [35] | RCT | 8.25 years | 17 (41) | 1 year | 0.15 IU/kg/day | NA (Germany research team) | Increase height velocity. |
(1) Lindgren et al. (1997) [36] | RCT | 3–12 years | 27 (n/a) | 2 years | Group A: 0.1 IU/kg/day | The Swedish National Growth Hormone Advisory Group | (1) Increased height SDS, reduced the percentage body fat and increased the muscle area of the thigh. |
(2) Lindgren et al. (1999) [37] | Group B: 0.2 IU/kg/day | (2) Increased insulin blood levels, unchanged fasting glucose and HbA1c but decreased glucose elimination rate after an intravenous glucose test. | |||||
(1) Carrel et al. (1999) [38] | RCT | 9.8 years | 54 (48) control, 19; GH group, 35 | 12 months, 24 months [40] | 1 mg/m2/day | NA (USA research team) | (1, 2) Increased height velocity Z-scores; decreased percent body fat; and improved respiratory muscle function, physical strength, and agility. However, resting energy expenditure did not change. |
(2) Myers et al. (1999) [39] | |||||||
(3) Myers et al. (2000) [40] | (3) Sustained increase in lean body mass, decrease in body fat percentage, improvements in physical strength and agility, and increased fat oxidation after 24 months. | ||||||
Carrel et al. (2001) [41] | RCT | 10.9 years (5–16) | 46 (48) | 36 months | 1 mg/m2/day (24 months) | NA (USA research team) | Decrease in fat mass and increase in lean body mass, growth velocity, and resting energy expenditure occurred with the standard 1.5 mg/m2/day, but not with lower doses of GH. |
0.3–1.5 mg/m2/day (25–36 months) | |||||||
Obata et al. (2003) [33] | Retrospective | 6 months–14 years | 37 (49) | 6 months-5 years | 0.5 IU/kg/week | Japanese | Improved height velocity, height SDS, final height, and the degree of obesity. |
Carrel et al. (2004) [30] | RCT | 15±9 months (4–37) | 29 (45) | 12 months | 1 mg/m2/day | NA (USA research team) | Decreased percent body fat, increased lean body mass, increased height velocity Z-scores, and patients <18 months old showed higher mobility skill acquisition. |
Myers et al. (2007) [42] | RCT | Mean 15±9 months (154–37) | 25 (n/a) | 2 years | GHT (1 mg/m2/day) or 1 year without GH and then placed on GH (1.5 mg/m2/day) for 1 year | NA (USA research team) | Normalization of length/height SDS, faster head growth, increased lean body mass accrual, and decreased percent body fat, as well as improved language and cognitive quotient Z-scores. |
Lin et al. (2008) [43] | Retrospective | 4.3±3.0 years | 27 (70) | 3 years | 0.1 IU/kg/day | Taiwanese | Increased height SDS, decreased BMI SDS, decreased Rohrer index. |
Meinhardt et al. (2013) [44] | Retrospective | 3.8±3.0 years | 41 (n/a) | 4.1 years | 0.03–0.06 mg/kg/day | Switzerland, Denmark, and Germany | Significant improvements in height and body composition. |
(1) Kuppens et al. (2016) [45] | RCT, crossover study on young adults with PWS who were treat- ed with GH from childhood until attainment of AH | 17.2 years (at the initiation of GH in this study) | 27 (70) | 2 years | 0.67 mg/m2/day | NA (Dutch research team) | (1) Compared with GH treatment, 1 year of placebo after attainment of AH did not deteriorate BMD SDS in young adults with PWS. GH did not prevent the decline in BMD SDS in hypogonadal young adults with PWS, unless combined with sex steroid replacement therapy. |
(2) Kuppens et al. (2017) [34] | 8.5 years (at the onset of previous GH therapy) | (2) Compared with placebo, GH treatment resulted in similar glucose and insulin levels during oral glucose tolerance tests. GH treatment had no adverse effects on metabolic health profile. | |||||
(3) Donze et al. (2018) [46] | (3) Lower fat mass and higher lean body mass compared to placebo group. | ||||||
Yang et al. (2019) [26] | RCT | 6.3 months (2.3–24) | 34 (62) | 52 weeks | 0.24mg/kg/week | South Korea | Increased height SDS and lean body mass, decreased fat mass (%), improved motor and cognitive develop- ments. |
Angulo et al. (2020) [47] | Observational | 4.42 years | 129 (50) | 2.48 years | 0.03mg/kg/day | ANSWER Program (USA), NordiNet IOS (Europe and the Middle East) | Increased height SDS, earlier treatment resulted in a greater increase in height, and a longer treatment peri- od resulted in better outcomes for both height and BMI. |
Passone et al. (2020) [24] | Meta-analysis (16 RCTs and 20 NRCTs) | NA | NA | NA | NA | Sweden (3), Netherland (17), USA (8), Denmark (2), Australia (2), Finland (1), Taiwan (1), France (2), Germany (1), Switzerland (1) | Improvement in height (1.67 SD), BMI Z-scores (–0.67 SDS) and fat mass proportion (–6.5% SDS). |
Grootjen et al. (2022) [48] | Open-label, prospective study | 1.92 years | 104 (NA) | 8 years | 1 mg/m2/day | Netherland | Better body composition and tall height in treated group. Especially, lower trunk/peripheral fat ratio, lower fat mass and higher IQ in group A. |
Group A: <1 | Control: 22 | ||||||
Group B: 2–5 | GH group: 82 |
GH, growth hormone; GHT, growth hormone therapy; RCT, randomized controlled trial; NA, not available; SDS, standard deviation score; HbA1c, hemoglobin A1c; BMI, body mass index; PWS, Prader-Willi syndrome; AH, adult height; BMD, bone mineral density; NRCT, non-randomized controlled trial; SD, standard deviation; IQ, intelligence quotient.
Study | Study design | Age at the time of study | No. of patients (female %) | GHT duration | GH dose | Country/ Ethnicity | Outcomes |
---|---|---|---|---|---|---|---|
Grugni et al. (2023) [63] | Longitudinal | Median of 27.1 years | 12 (42) | 17 years | 0.35 mg/day | Caucasian | Lower waist circumference, reduction of fat mass (%), a slight impairment of glucose homeostasis (an increase in only the fasting glucose). |
Frixou et al. (2021) [64] | Meta-analysis (20 papers) | Median of 26.2 years | 424 (49) | Median of 1 year | Median of 0.8 mg/day | Japan (1), Netherlands (3), Italy (5), Sweden (8), Norway (3), Denmark (3), USA (2) | Increase in LBM and reductions in FM (%). The impact on cholesterol, echocardiography, and BMD remains unclear. |
Rosenberg et al. (2021) [65] | Meta-analysis (9 RCTs and 20 NRCTs) | The median or average age is not provided | RCTs (the sample size per study ranged from 26 to 27 individuals) | From a minimum of 1 year to a maximum of 15 years | Individually titrated | NA | With over 12 months of GH treatment, body composition improved with increased lean body mass and reduced fat mass. However, no significant changes were observed in BMI, cholesterol levels, glucose levels, or bone mineral density. |
NRCTs (the sample size per study ranged from 10 to 1,067 individuals) |
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