Pregnancy outcomes in women receiving growth hormone replacement therapy enrolled in the NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program

Abstract Purpose Data on the safety of growth hormone (GH) replacement therapy during pregnancy are limited. We report a combined analysis of data from pregnant women treated with GH while enrolled in two non-interventional, multicenter studies: NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program. Methods Pregnancy data were pooled from NordiNet® IOS and the ANSWER Program. Data were collected during routine clinic visits by participating physicians using a web-based system. Patients exposed to GH replacement therapy during pregnancy were included in the analysis. Results The study population included 40 female patients with typical causes of adult GH deficiency (GHD). Overall, there were 54 pregnancies. Of these, 47 were exposed to GH between conception and delivery. In 48.9% of pregnancies exposed to GH, the dose was > 0.6 mg/day. GH was continued past conception and then stopped during the first, second, and third trimester, in 27.7%, 17.0%, and 2.1% of pregnancies, respectively. In 29.8%, GH was continued throughout pregnancy, with an unchanged dose in most cases. Of the 47 GH-exposed pregnancies, 37 (78.7%) progressed to normal delivery. There were three adverse events reported in two pregnancies. Conclusion These real-world data suggest that there were no new safety signals related to GH exposure in women with GHD during pregnancy. These results are consistent with findings from previous studies reporting data in pregnancies exposed to GH at conception or throughout pregnancy. This observational study in additional pregnancies provides further evidence that GH exposure does not adversely affect pregnancy outcome. Clinical trial registration: ClinicalTrials.gov NCT00960128 (date of registration: August 13, 2009) and NCT01009905 (date of registration: November 5, 2009).

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Intracranial endodermal sinus tumors associated with growth hormone replacement therapy in a girl

Journal of Neurosurgery Pediatrics ◽

10.3171/2011.10.peds1195 ◽

2012 ◽

Vol 9 (1) ◽

pp. 49-53 ◽

Cited By ~ 2

Author(s):

Zhiwei Tang ◽

Xiang'en Shi ◽

K. I. Singh Khatri Chhetri ◽

Xueling Qi

Keyword(s):

Growth Hormone ◽

Replacement Therapy ◽

Causal Effect ◽

Hormone Replacement ◽

Germ Cell Tumors ◽

Pineal Region ◽

Histopathological Analysis ◽

Growth Hormone Replacement Therapy ◽

Gh Replacement ◽

Frontal Horn

The primary intracranial endodermal sinus tumor (EST) is regarded as a rare histological subtype that is often associated with components of other germ cell tumors, and there are no reports on the onset of intracranial ESTs after growth hormone (GH) replacement therapy. The authors report an extremely rare case of pure primary EST associated with GH replacement therapy. A 15-year-old girl with GH deficiency experienced headache, nausea, and vomiting after GH replacement therapy for a 17-month period. Magnetic resonance imaging showed 2 tumor masses located in the pineal region and frontal horn of the right lateral ventricle, respectively. Before surgery, the authors administered 1 cycle of neoadjuvant chemotherapy, which shrank the tumor and facilitated surgical intervention. The larger mass located in the pineal region was removed via a right occipital transtentorial approach, and postoperative histopathological analysis revealed a pure EST. While there is a clear association between the initiation of GH replacement therapy and the development of the EST in this case, the causal effect cannot be specified. Nevertheless, this case demonstrates that GH replacement therapy must be used cautiously.

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Cardiac status after long-term growth hormone replacement therapy in adult growth hormone deficient patients. A single centre audit based on echocardiographic investigations before and during GH replacement therapy

Endocrine Abstracts ◽

10.1530/endoabs.41.gp58 ◽

2016 ◽

Author(s):

Sissela Skoglund ◽

Ulla Feldt Rasmussen ◽

Marianne Klose ◽

Christian Hassager

Keyword(s):

Growth Hormone ◽

Replacement Therapy ◽

Hormone Replacement ◽

Growth Hormone Replacement ◽

Single Centre ◽

Growth Hormone Replacement Therapy ◽

Gh Replacement ◽

Adult Growth ◽

Cardiac Status

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The effect of Growth Hormone replacement therapy on Lipid Metabolism in Georgian patients with Growth Hormone Deficiency

European Scientific Journal ESJ ◽

10.19044/esj.2017.v13n27p19 ◽

2017 ◽

Vol 13 (27) ◽

pp. 19

Author(s):

Nestan Bostoganashvili ◽

Elene Giorgadze ◽

Shota Janjgava ◽

Marine Lomidze

Keyword(s):

Growth Hormone ◽

Hormone Replacement Therapy ◽

Lipid Profile ◽

Replacement Therapy ◽

Gh Deficiency ◽

Hormone Replacement ◽

Hormone Deficiency ◽

Growth Hormone Replacement ◽

Growth Hormone Replacement Therapy ◽

Gh Replacement

Introduction: Recently, Growth hormone deficiency (GHD) has become one of the reasons of significant metabolic and psychological morbidity in children and adults. The aim of our study was to find out the impact of GH replacement therapy on lipid profile in Georgian patients with GHD, which was caused by surgical resection. Design: Double Blind placebo controlled study for 12 months and an open study for another 12 months. Patients and Methods: 20 Georgian adults, aged 40.75±2.2 years (mean ± SE, range 20.5-60), with adult onset GH deficiency were enrolled in the study. The patients were selected from the basis of National Institute of Endocrinology. We set the inclusive and exclusive criteria to study these patients, who needed the growth hormone replacement therapy. We collected standardized information about central and peripheral hormones, metabolic activity and physical features. Results: after 12 months of GH replacement, there was no significant improvement of lipid profile in the GH deficient patients. After 24 months of the treatment, the study showed the upward trend of Triglycerides, Total cholesterol and HDL-CH, and a decrease of LDL-CH. Conclusion: The response of lipid profile to the 12 and 24 months of GH replacement in patients with GH deficiency was disappointing. The results significantly differ from the ones, provided by the European Endocrine societies. Thus, longer-term studies are required, in order to investigate accurately the whole lipid profile among our patients for the following years.

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