A care service model for cost effective and structured individualised treatment choice for GH replacement therapy

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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Changes In Prothrombin And Activated Partial Thromboplastin Time During Replacement Therapy With Human Recombinant Growth Hormone In Growth Hormone Deficient Adults

American Journal of Clinical Pathology ◽

10.1093/ajcp/aqaa161.224 ◽

2020 ◽

Vol 154 (Supplement_1) ◽

pp. S102-S103

Author(s):

Y S Kamel

Keyword(s):

Growth Hormone ◽

Replacement Therapy ◽

Healthy Subjects ◽

Recombinant Growth Hormone ◽

Gh Replacement ◽

Coagulation Tests ◽

Before And After ◽

Human Recombinant Growth Hormone ◽

Male Patients ◽

One Year

Abstract Introduction/Objective The aim of this study was to investigate the effects of GH administration on basic coagulation parameters: PT, aPTT and fibrinogen concentrations in adult GHD patients before and during one year of GH replacement. Methods Twenty-one adult patients with severe GHD (mean age +/- SE: 38.6 +/- 2.8 years) were included in this hospital based, prospective, interventional study. All patients were treated with rhGH for 12 months (GH dose: 0.4 mg/day for male and 0.6 mg/day for female patients). IGF-1 concentrations were determined using RIA-INEP kits. Basic coagulation tests, i.e. aPTT and fibrinogen concentrations, were measured before and after 3, 6 and 12 months of treatment with rhGH. Control values were obtained from fourteen “healthy” subjects matched by age, sex and body mass index (BMI). Results At baseline, we observed no significant differences in PT, aPTT and fibrinogen values between GHD and healthy subjects. IGF-1 concentrations increased significantly within 3 months of GH therapy (8.2 +/- 1.5 vs. 24.2 +/- 2.9 nmol/l, p <0.05) and remained stable thereafter. A significant increase in PT values, which was more pronounced in female subjects, was noted after 6 and 12 months of treatment with GH. aPTT values increased significantly after 12 months of treatment only in male patients (28.8 +/- 4.6 vs. 39.7 +/- 2.1 s.; p <0.05). No significant changes in fibrinogen concentrations were found during the study. Conclusion Twelve months of GH replacement therapy led to a significant increase in PT and aPTT values in adult GHD patients, while fibrinogen concentrations did not change. Changes in PT were more pronounced in female GHD patients, while an increase in aPTT values was observed only in male patients with GHD. The clinical significance of these changes needs further evaluation.

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Utility of P300 auditory event related potential latency in detecting cognitive dysfunction in growth hormone (GH) deficient patients with Sheehan's syndrome and effects of GH replacement therapy

Acta Endocrinologica ◽

10.1530/eje.0.1500153 ◽

2004 ◽

pp. 153-159 ◽

Cited By ~ 33

Author(s):

A Golgeli ◽

F Tanriverdi ◽

C Suer ◽

C Gokce ◽

C Ozesmi ◽

...

Keyword(s):

Growth Hormone ◽

Cognitive Function ◽

Replacement Therapy ◽

Patient Group ◽

Gh Deficiency ◽

Event Related Potential ◽

Sheehan’S Syndrome ◽

Gh Replacement ◽

Igf I ◽

Sheehan's Syndrome

OBJECTIVE: Impaired cognitive function has been demonstrated in adults with growth hormone (GH) deficiency (GHD) by using different neuropsychological tests. Despite several studies, present knowledge about the impact of GHD and GH replacement therapy (GHRT) on cognitive function is limited. P300 event-related potential (ERP) application is a well-established neurophysiological approach in the assessment of cognitive functions including the updating of working memory content and the speed of stimulus evaluation. GHD is a well-known feature of Sheehan's syndrome and cognitive changes due to GHD and the effects of GHRT remain to be clarified. The present study was designed to investigate the effects of GHD and 6 months of GHRT on cognitive function in patients with Sheehan's syndrome by using P300 latency. DESIGN AND METHODS: The study comprised 14 patients with Sheehan's syndrome (mean age, 49.5+/-7.8 years) and 10 age-, education- and sex-matched healthy controls. With hormone replacement therapy, basal hormone levels other than GH were stable before enrollment and throughout the GHRT. The diagnosis of GH deficiency was established by insulin-tolerance test (ITT), and mean peak level of GH in response to insulin hypoglycemia was 0.77+/-0.35 mIU/l. Treatment with GH was started at a dose of 0.45 IU (0.15 mg)/day in month 1, was increased to 0.9 IU (0.30 mg)/day in month 2 and was maintained at 2 IU (0.66 mg)/day. Initially baseline auditory ERPs in patients and controls were recorded at frontal (Fz), central (Cz), and parietal (P3 and P4) electrode sites. In the patient group, ERPs were re-evaluated after 6 months of GH replacement therapy. During each session P300 amplitude and latency were measured. RESULTS: Mean serum insulin-like growth factor-I (IGF-I) concentration in the patient group before GHRT was 23+/-13 ng/ml. After 6 months of GH therapy mean IGF-I significantly increased to an acceptable level, 234+/-71 ng/ml (P<0.05). The mean latencies (at all electrode sites) of the patients before GHRT were found to be significantly prolonged when compared with those of normal controls (P<0.05). After 6 months of GHRT mean P300 latencies (at all electrode sites) were decreased significantly when compared with latencies before treatment (P<0.05). CONCLUSIONS: The present study, using P300 ERP latencies, therefore suggests an impairment of cognitive abilities due to severe GHD in patients with Sheehan's syndrome and an improvement of cognitive function after 6 months of physiological GHRT. Moreover, this was a novel application of P300 ERP latencies in cognitive function detection in patients with GHD. Further studies with different patient groups need to be done to assess the clinical use of this electrophysiological method in the diagnosis of cognitive dysfunction due to GHD.

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Tumor Recurrence or Regrowth in Adults With Nonfunctioning Pituitary Adenomas Using GH Replacement Therapy

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jc.2015-1764 ◽

2015 ◽

Vol 100 (8) ◽

pp. 3132-3139 ◽

Cited By ~ 13

Author(s):

N. C. van Varsseveld ◽

C. C. van Bunderen ◽

A. A. M. Franken ◽

H. P. F. Koppeschaar ◽

A. J. van der Lely ◽

...

Keyword(s):

Replacement Therapy ◽

Pituitary Adenomas ◽

Tumor Recurrence ◽

Nonfunctioning Pituitary Adenomas ◽

Gh Replacement

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Issues in the Transition From Childhood to Adult Growth Hormone Therapy

PEDIATRICS ◽

10.1542/peds.104.s5.1004 ◽

1999 ◽

Vol 104 (Supplement_5) ◽

pp. 1004-1010

Author(s):

David B. Allen

Keyword(s):

Growth Hormone ◽

Replacement Therapy ◽

Blood Lipid ◽

Hormone Deficiency ◽

Late Adolescent ◽

Gh Therapy ◽

Gh Treatment ◽

Beneficial Effects ◽

Gh Replacement ◽

Adult Growth

The consequences of severe growth hormone deficiency (GHD) in adults and the beneficial effects of GH replacement therapy are clear. However, the majority of children who have a diagnosis of GHD and who are treated with GH do not have permanent GHD and will not require treatment during adulthood. Several issues must be considered in selecting candidates for adult GH treatment and transitioning their care from pediatrics to adult medicine. Counseling about possible lifelong treatment should focus on children with panhypopituitarism and those with severe isolated GHD that is associated with central nervous system abnormalities. When to terminate growth-promoting GH therapy should be guided by balancing the high cost of late-adolescent treatment with the attainment of reasonable statural goals. Retesting for GH secretion is appropriate for all candidates for adult GH therapy; the GH axis can be tested within weeks after the cessation of treatment, but confirming an emerging adult GHD state with body composition, blood lipid, and quality-of-life assessments may require 1 year or more of observation. Selecting patients for lifelong adult GH replacement therapy will present diagnostic, therapeutic, and ethical problems similar to those in treating childhood GHD. The experience and expertise of pediatric endocrinologists in diagnosing and treating GHD should be offered and used in identifying and transitioning appropriate patients to adult GH therapy.

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Regrowth of non-secreting pituitary adenoma and craniopharyngioma prior to GH-replacement therapy in KIMS

Growth Hormone & IGF Research ◽

10.1016/s1096-6374(98)80155-x ◽

1998 ◽

Vol 8 (4) ◽

pp. 318

Author(s):

P Wilton ◽

R Abs ◽

B-A Bengtsson ◽

U Feldt-Rasmussen ◽

E Hernberg-Stahl ◽

...

Keyword(s):

Pituitary Adenoma ◽

Replacement Therapy ◽

Gh Replacement

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Study of Lipid Profiles levels in Iraqi children with GH Deficiency Before and after 6 Months GH Replacement Therapy

Indian Journal of Forensic Medicine & Toxicology ◽

10.37506/ijfmt.v14i4.12308 ◽

2020 ◽

Keyword(s):

Replacement Therapy ◽

Gh Deficiency ◽

Lipid Profiles ◽

Gh Replacement ◽

Before And After

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Implementation of a novel primary care pathway for patients with severe and enduring mental illness

BJPsych Bulletin ◽

10.1192/pb.bp.116.055830 ◽

2017 ◽

Vol 41 (6) ◽

pp. 314-319 ◽

Cited By ~ 6

Author(s):

Frank Röhricht ◽

Gopal Krishan Waddon ◽

Paul Binfield ◽

Rhiannon England ◽

Richard Fradgley ◽

...

Keyword(s):

Primary Care ◽

Mental Illness ◽

Secondary Care ◽

Care Pathway ◽

Care Service ◽

Significant Proportion ◽

Cost Effective ◽

Care Patient ◽

Care Models

Aims and methodNew collaborative care models with an emphasis on primary care are required for long-term management of patients with severe and enduring mental illness (SMI). We conducted a descriptive evaluation of clinical outcomes of the first 3 years of a novel enhanced primary care (EPC) service. Data from 2818 patients and staff survey results were analysed.Results2310 patients were discharged to EPC (508 not assessed as clinically suitable or patients/general practitioners declined the transfer); mean length of stay with secondary care service of the cohort was 9.8 years (range 0–24). 717 patients (31%) have been discharged to primary care only out of the EPC services and 233 patients (10%) have been transferred back to secondary care. Patient and staff satisfaction with the new EPC model was high. No severe untoward incidents were recorded.Clinical implicationsThe data suggest that EPC can be safely provided for a significant proportion of patients with SMI, who traditionally received long-term secondary care support. The novel EPC model can be utilised as a template for the provision of cost-effective, recovery-oriented and non-stigmatising care in the community.

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