Efficacy of Somapacitan in Treatment-Fatigue Adult Patients With Growth Hormone Deficiency Previously Treated With Once-Daily Growth Hormone Injections: A 24-Week Randomized Active-Controlled Trial.
Mojca Jensterle, Rok Herman, Ana Klinc, Katja Goričar, Matej Rakusa, Andrej Janež
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Abstract
Objective: We evaluated the efficacy of somapacitan in a 24-week, randomized, active-controlled study in patients with growth hormone deficiency (GHD) who experienced fatigue from daily growth hormone (GH) injections.
Methods: Twenty-nine adult patients with GHD, pretreated with daily GH for ≥5 years, who had reported treatment-related fatigue, were randomized to somapacitan or daily GH. Outcome measures were changes in treatment satisfaction assessed by Treatment Satisfaction Questionnaire for Medication-9, insulin-like growth factor-1 (IGF-1) standard deviation score, glucose and lipid parameters, body composition, bone mineral density (BMD), carotid intima media thickness, and reactive hyperaemia index, from baseline to week 24.
Results: The difference in change in Treatment Satisfaction Questionnaire for Medication-9 score for convenience was significant, in favor of somapacitan (estimated difference, somapacitan-daily GH [95% CI]:23.2 [7.9; 38.4] points, P = .004). No differences between treatment arms in estimated changes from baseline to study-end were observed for IGF-1 levels, glucose and lipid profile, visceral adipose tissue, fat mass (%), lean body mass, and vascular parameters. There was significant difference in BMD of the lumbar spine (estimated difference, somapacitan-daily GH [95% CI] -0.036 (-0.064, -0.009) gr/cm2, P = .011).
Conclusion: In AGHD patients who were fatigued from the long-term daily GH injections, somapacitan was reported to be more convenient than daily GH. It was effective in maintaining IGF-1 levels and body composition, glucose, lipids, and vascular parameters, comparable to daily GH. Nonsignificant decrease in BMD with somapacitan could reflect a favorable increase in bone metabolic units, as previously observed in naïve patients with GHD during the initial 6-month period of GH therapy.
期刊介绍：
Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.
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