Abstract
PurposeData 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.MethodsPregnancy 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.ResultsThe 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.ConclusionThese 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).
Highlights
Growth hormone (GH) deficiency (GHD) in adults is characterized by metabolic abnormalities, impaired psychosocial function, high levels of circulating cardiovascular risk biomarkers (C-reactive protein, plasminogen activator inhibitor [PAI-1], total cholesterol, lowdensity lipoprotein cholesterol), and fatigue [1,2,3,4]
We report a combined analysis of data from pregnant women treated with GH while enrolled in two non-interventional, multicenter studies: the NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: WebEnabled Research (ANSWER) Program [21, 22]
The newborn had no illness or abnormalities. These three adverse events (AEs) were assessed to be unlikely to be related to GH treatment. This analysis of pregnancy data and outcomes from two large non-interventional, real-world studies, NordiNet® IOS and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program, combining data from 47 pregnancies exposed to GH during pregnancy, provides insight into the use of GH replacement during pregnancy in realworld practice in Europe and the USA
Summary
Growth hormone (GH) deficiency (GHD) in adults is characterized by metabolic abnormalities (e.g., abdominal obesity, insulin resistance, reduced lean body mass), impaired psychosocial function, high levels of circulating cardiovascular risk biomarkers (C-reactive protein, plasminogen activator inhibitor [PAI-1], total cholesterol, lowdensity lipoprotein cholesterol), and fatigue [1,2,3,4]. The goal of GH replacement therapy (GHRT) in adults with GHD is to normalize insulin-like growth factor-1 (IGF-I) levels, and thereby improve body composition, mitigate cardiovascular risk, maintain skeletal mass, and optimize physical and psychological function [9]. The increase in placental GH levels is not suppressed by concomitant GHRT [10]. During this time, pituitary GH secretion decreases gradually to undetectable levels in maternal serum by week 36 of gestation [11]
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