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Sökning: WFRF:(Höybye Charlotte)

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  • Backeljauw, Philippe, et al. (författare)
  • Safety and Effectiveness of Recombinant Human Growth Hormone in Children with Turner Syndrome : Data from the PATRO Children Study
  • 2021
  • Ingår i: Hormone Research in Paediatrics. - : S. Karger. - 1663-2818 .- 1663-2826. ; 94:3-4, s. 133-143
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: PATRO Children is an international, observational, postmarketing surveillance study for a biosimilar recombinant human growth hormone (rhGH; somatropin, Omnitrope (R); Sandoz), approved by the European Medicines Agency in 2006. We report safety and effectiveness data for patients with Turner syndrome (TS).Methods: The study population included infants, children, and adolescents with TS who received Omnitrope (R) treatment according to standard clinical practice. Adverse events (AEs) were monitored for safety evaluation, and height velocity (HV), height standard deviation score (HSDS), and HVSDS were calculated to evaluate treatment effectiveness.Results: As of August 2019, 348 TS patients were enrolled from 130 centers. At baseline, 314 patients (90.2%) were prepubertal and 284 patients (81.6%) were rhGH treatment naive. The mean ( range) age at baseline was 9.0 (0.7-18.5) years, and mean (SD) treatment duration in the study was 38.5 (26.8) months. Overall, 170 patients (48.9%) reported AEs, which were considered treatment related in 25 patients (7.2%). One treatment-related serious AE was reported (intracranial hypertension). Mean.HSDS after 3 years of therapy was +1.17 in treatment-naive prepubertal patients and +0.1 in pretreated prepubertal patients. In total, 51 patients (31.1%) reached adult height (AH), 35 of whom were rhGH treatment naive; in these patients, mean (SD) HSDS was -2.97 (1.03) at the start of Omnitrope (R) treatment, and they achieved a mean (SD) AHSDS of -2.02 (0.9).Conclusion: These data suggest that biosimilar rhGH is well tolerated and effective in TS patients managed in reallife clinical practice. Optimization of rhGH dose may contribute to a higher AH. (C) 2021 S. Karger AG, Basel
  • Fridman-Bengtsson, Ola, et al. (författare)
  • Evaluation of different hydrocortisone treatment strategies in transsphenoidal pituitary surgery
  • 2019
  • Ingår i: Acta Neurochirurgica. - : Springer Nature. - 0001-6268 .- 0942-0940. ; 161:8, s. 1715-1721
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundHydrocortisone treatment in transsphenoidal pituitary surgery has been debated. Although several publications advocate restrictive treatment, centers around the world administer stress doses of hydrocortisone in patients with presumed intact cortisol production. Our aim with this analysis was to compare postoperative hypocortisolism in patients who received three different protocols of hydrocortisone therapy during and after surgery.MethodThis was a retrospective observational study. Based on perioperative hydrocortisone dose given, patients were divided in three groups: high dose (HD), intermediate dose (ID), and low dose (LD). Postoperative evaluation of the pituitary function was performed using S-cortisol at day 4 and short Synacthen test (SST) at 6–8 weeks. Patients with ACTH-producing adenomas or preoperative hydrocortisone treatment were excluded.ResultThere was no difference between the groups regarding failure rate of SST. The rate of failed SST (all groups) was 51/186 (27%), 24/74 (32%) in the HD group and 26/74 (35%) and 11/38 (29%) in the ID and LD groups respectively. There was no significant difference between the ID and LD groups regarding S-cortisol at postoperative day 4 regarding serum cortisol level below 200 nmol/L. There was a significant but weak correlation, rs 0.330 (P < 0.01) between S-cortisol day 4 and SST at 4–6 weeks.ConclusionsPeri and postoperative hydrocortisone treatment did not affect SST response 6–8 weeks postoperatively, whereas the rate of patients with S-cortisol below 200 nmol/L at postoperative day 4 did. LD hydrocortisone therapy seems to favor a better endogenous production in the early postoperative phase.
  • Höybye, Charlotte, et al. (författare)
  • Change in baseline characteristics over 20 years of adults with growth hormone (GH) deficiency on GH replacement therapy
  • 2019
  • Ingår i: European Journal of Endocrinology. - : Society of the European Journal of Endocrinology. - 0804-4643. ; 181:6, s. 629-638
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: Clinical observations over time of adults with growth hormone (GH) deficiency (GHD) have indicated a shift in patient characteristics at diagnosis. The objective of this study was to compare baseline characteristics of patients diagnosed with adult-onset GHD naive to GH replacement during t hree study periods (1994-1999 (P1), 2000-2004 (P2), and 2005-2012 (P3)) using the KIMS (Pfizer's International Metab olic) database. Methods: Data were retrieved for a total of 6069 patients with adult-on set GHD from six countries (Belgium, Germany, Netherlands, Spain, Sweden, and UK): P1 (n = 1705), P2 (n = 2397), and P3 (n = 1967). Results: The proportions of patients with pituitary/hypothalamic tumors and patients with multiple pituitary hormone deficiencies decreased per entry year period, while the proporti ons with hypertension and diabetes increased. The lag time from diagnosis of pituitary disease to start of GH treatme nt decreased by 2.9 years over the entry year periods. IGF-1 increased by 0.1 standard deviation score per entry year period. Maximum GH following various stimulation tests, BMI, and waist circumference increased. The use of radio therapy, glucocorticoid replacement doses, and the proportion of women >50 years on estrogen replacement therapy decreased. The effects of 1 year of GH replacement were similar over the entry year periods despite changes in the patients' baseline characteristics. An expected increase in fasting blood glucose was seen after 1 year of GH treatment. Conclusions: The degree of confirmed GHD became less pronounced and more pat ients with co-morbidities and diabetes were considered for GH replacement therapy, possibly r eflecting increased knowledge and confidence in GH therapy gained with time.
  • Höybye, Charlotte, et al. (författare)
  • Clinical features of GH deficiency and effects of 3 years of GH replacement in adults with controlled Cushing's disease.
  • 2010
  • Ingår i: European journal of endocrinology / European Federation of Endocrine Societies. - 1479-683X. ; 162:4, s. 677-84
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: Patients in remission from Cushing's disease (CD) have many clinical features that are difficult to distinguish from those of concomitant GH deficiency (GHD). In this study, we evaluated the features of GHD in a large cohort of controlled CD patients, and assessed the effect of GH treatment. DESIGN AND METHODS: Data were obtained from KIMS, the Pfizer International Metabolic Database. A retrospective cross-sectional comparison of background characteristics in unmatched cohorts of patients with CD (n=684, 74% women) and nonfunctioning pituitary adenoma (NFPA; n=2990, 39% women) was conducted. In addition, a longitudinal evaluation of 3 years of GH replacement in a subset of patients with controlled CD (n=322) and NFPA (n=748) matched for age and gender was performed. RESULTS: The cross-sectional study showed a significant delay in GHD diagnosis in the CD group, who had a higher prevalence of hypertension, fractures, and diabetes mellitus. In the longitudinal, matched study, the CD group had a better metabolic profile but a poorer quality of life (QoL) at baseline, which was assessed with the disease-specific questionnaire QoL-assessment of GHD in adults. After 3 years of GH treatment (mean dose at 3 years 0.39 mg/day in CD and 0.37 mg/day in NFPA), total and low-density lipoprotein cholesterol decreased, while glucose and HbAlc increased. Improvement in QoL was observed, which was greater in the CD group (-6 CD group versus -5 NFPA group, P<0.01). CONCLUSION: In untreated GHD, co-morbidities, including impairment of QoL, were more prevalent in controlled CD. Overall, both the groups responded similarly to GH replacement, suggesting that patients with GHD due to CD benefit from GH to the same extent as those with GHD due to NFPA.
  • Höybye, Charlotte (författare)
  • Endocrine and metabolic aspects of adult Prader Willi syndrome with special emphasis on the effect of growth hormone treatment
  • 2003
  • Doktorsavhandling (övrigt vetenskapligt)abstract
    • Prader Willi Syndrome (PWS) is a complex genetic disorder characterized by muscular hypotonia, hyperphagia, obesity and behavioural problems. Partial growth hormone (GH) deficiency and hypogonadism are common. Results of several GH treatment studies in children with PWS have shown improvements not only in growth, but also in body composition, physical strength and agility. The partial GH deficiency seen in PWS might render these patients at risk of metabolic diseases in adult life and of reduced life span. The non-growth effects of GH treatment in PWS children have directed the interest towards the PWS adults in preventing the long-term consequences of GH deficiency. Until recently, neither the endocrine and metabolic consequences of the syndrome in adult patients, nor the potential effects of GH treatment have been known in detail. Aims: To study endocrine, metabolic and psycho-social functions, in adult PWS patients and the impact of GH treatment on these parameters. Patients and methods: We examined a cohort of 19 adult patients with clinical PWS (13 with PWS genotype) of which 17 (9 men and 8 women) with a mean age of 25 years and a mean BMI of 35 k g/M 2, subsequently completed a 12 months GH treatment trial. Results and discussion: At baseline all but three patients were obese despite a strict diet. Waist/hip ratio was increased in all women, and the mean percentage body fat was high in both genders. The activity of the GH-insulin-like-growth-factor-I (IGF-I) system was impaired with low GH values, low total IGF-I and in relation to the obesity low levels of free IGF-I and non-suppressed IGF-binding- protein-1 (IGFBP-1). Approximately two thirds were biochemically hypogonadal. Bone mineral density (BMD) was low. Four patients had impaired glucose tolerance and 9 patients high homeostasis model assessment (HOMA) index, indicating insulin resistance. A moderate dyslipidemia was seen in seven patients. The 13 patients with genetically confirmed diagnosis were shorter and had significantly lower IGF-I. GH treatment showed beneficial effects on body composition with reduction in body fat and increase in lean body mass following 6 and 12 months of therapy with doses, that normalized total IGF-I levels. The effects were more pronounced in the patients with the PWS genotype. Carbohydrate and lipid metabolism was not significantly affected by GH treatment. The aetiology of hyperphagia in PWS is not known. Examination of peptides involved in appetite regulation, showed that leptin levels were high reflecting obesity, and as a consequence NPY levels were low. In view of the adiposity of the patients circulating oxytocin levels were abnormally low and circulating ghrelin levels abnormally high. Therefore oxytocin as well as ghrelin might be involved in the hyperphagia. The peptides involved in appetite regulation did not change during GH treatment. Psychological evaluation revealed positive effects on intellectual speed and flexibility, reaction time and motor speed. When GH was discontinued significant impairments in physical and social function as well as in the over-all functioning were seen, as judged from questionnaires to relatives and caretakers. Conclusion: GH treatment might offer an opportunity to reduce some of the adverse consequences of the PWS syndrome. It should be remembered, however, that dysfunction of the GH-IGF-I axis and the potential effects hereof are only minor parts of the clinical syndrome. Larger and longer term studies on the effect of GH replacement in adult PWS patients should be carried out.
  • Höybye, Charlotte, et al. (författare)
  • Safety and effectiveness of replacement with biosimilar growth hormone in adults with growth hormone deficiency: results from an international, post-marketing surveillance study (PATRO Adults).
  • 2021
  • Ingår i: Pituitary. - 1573-7403. ; 24:4, s. 622 - 629
  • Tidskriftsartikel (refereegranskat)abstract
    • To evaluate safety and effectiveness of biosimilar recombinant human growth hormone (rhGH; Omnitrope®) in adults with growth hormone deficiency (GHD), using data from the PATRO Adults study.PATRO Adults was a post-marketing surveillance study conducted in hospitals and specialized endocrinology units across Europe. The primary objective was to assess the safety of rhGH in adults treated in routine clinical practice. All adverse events (AEs) were monitored and recorded for the complete duration of Omnitrope® treatment. Effectiveness was evaluated as a secondary objective.As of January 2020, 1447 patients (50.9% male) had been enrolled from 82 centers in 9 European countries. Most patients had adult-onset GHD (n = 1179; 81.5%); 721 (49.8%) were rhGH-naïve at study entry. Overall, 1056 patients (73.0%) reported adverse events (AEs; n = 5397 events); the majority were mild-to-moderate in intensity. Treatment-related AEs were reported in 117 patients (8.1%; n = 189 events); the most commonly reported (MedDRA preferred terms) were arthralgia (n = 19), myalgia (n = 16), headache (n = 14), and edema peripheral (n = 10). In total, 495 patients (34.2%) had serious AEs (SAEs; n = 1131 events); these were considered treatment-related in 28 patients (1.9%; n = 35 events). Mean (standard deviation) IGF-I SDS increased from - 2.34 (1.47) at baseline to - 0.23 (1.65) at 12 months, and remained relatively stable thereafter (up to 3 years). Body mass index remained stable between baseline and 3 years.Data from PATRO Adults indicate biosimilar rhGH (Omnitrope®) is not associated with any unexpected safety signals, and is effective in adults with GHD treated in real-world clinical practice.
  • Höybye, Charlotte, et al. (författare)
  • Transsphenoidal surgery in Cushing disease : 10 years of experience in 34 consecutive cases
  • 2004
  • Ingår i: Journal of Neurosurgery. - 0022-3085 .- 1933-0693. ; 100, s. 634-638
  • Tidskriftsartikel (refereegranskat)abstract
    • Object. Cushing disease is a rare disorder. Because of their small size the adrenocorticotropic hormone (ACTH)—producing tumors are often not detectable on neuroimaging studies. To obtain a cure with transsphenoidal surgery (TSS) may therefore be difficult. In this report the authors present 10 years of experience in the treatment of patients with Cushing disease who were followed up with the same protocol and treated by the same surgeon.Methods. Thirty-four patients, 26 of them female and eight of them male (mean age 40 years, range 13–74 years) were studied. All had obvious clinical signs and symptoms of Cushing syndrome. Magnetic resonance (MR) imaging was performed in all patients, and inferior petrosal sinus (IPS) sampling was done in 14.In 12 patients MR imaging indicated a pituitary tumor; 10 were microadenomas and two were macroadenomas. In six patients with no visible tumor, the results of IPS sampling supported the diagnosis. All patients underwent TSS; the mean follow-up duration was 6 ± 0.5 years. Selective adenomectomy was performed in 32 and hemihypophysectomy in the other two patients. A cure was obtained in 31 patients (91%) after one TSS and in two more patients after further TSS; one patient was not cured despite two TSSs and one underwent bilateral adrenalectomy. Disease recurrence was seen in two patients after 3 years, and they were successfully treated with stereotactic gamma knife surgery. Half of the patients had an ACTH deficiency postoperatively, whereas one third had other pituitary hormone insufficiencies. There were no serious complications attributable to the surgical intervention.Conclusions. Transsphenoidal surgery with selective adenomectomy is an effective and safe treatment for Cushing disease. In the patients presented in this study, the surgical outcome seemed to depend on careful preoperative evaluation and the surgeon's experience. For optimal results in this rare disease the authors therefore suggest that the endocrinological, radiological, and surgical procedures be coordinated in a specialized center.
  • Koltowska-Häggström, Maria, et al. (författare)
  • Discontinuation of Growth Hormone (GH) Treatment during the Transition Phase Is an Important Factor Determining the Phenotype of Young Adults with Nonidiopathic Childhood-Onset GH Deficiency
  • 2010
  • Ingår i: Journal of Clinical Endocrinology and Metabolism. - 0021-972X .- 1945-7197. ; 95:6, s. 2646-2654
  • Tidskriftsartikel (refereegranskat)abstract
    • Context: Little is known about the impact of childhood-onset GH deficiency (GHD), in particular the duration of GH cessation during the transition phase, on adult phenotype. Objective: We investigated the association between the manifestations and management of GHD during childhood/adolescence and the clinical features of GHD in adulthood. Design/Setting/Patients/Intervention: Patients with reconfirmed childhood-onset GHD who resumed GH treatment as adults were identified from two sequential databases (n = 313). The cohort was followed up longitudinally from GH start in childhood to reinitiation of treatment in adulthood and 1 yr beyond. Analyses were performed in the total cohort and in subgroups of patients with idiopathic GHD (IGHD) and non-IGHD. The cohorts were stratified based on duration of GH cessation (short, <= 2 yr; long, >2 yr). Main Outcome Measures: Regimen of pediatric GH administration, duration of GH interruption, IGF-I SD score, lipid concentrations, and quality of life were measured. Results: Mean duration of GH interruption was 4.4 yr. IGF-I SD score in adulthood was related to severity of childhood GHD. In non-IGHD patients, a longer duration of GH interruption was associated with a worse lipid profile (P < 0.0001). Non-IGHD patients who gained more height during childhood GH treatment reported better quality of life than those who gained less height (P < 0.05). Conclusions: Pediatricians should tailor GH treatment, not only for its beneficial effect on growth but also for future health in adulthood. In adults with reconfirmed GHD, particularly those with non-IGHD, early recommencement of GH should be considered.
  • Lundberg, Elena, 1961-, et al. (författare)
  • Ten years with biosimilar rhGH in clinical practice in Sweden : experience from the prospective PATRO children and adult studies
  • 2020
  • Ingår i: BMC Endocrine Disorders. - : BMC. - 1472-6823 .- 1472-6823. ; 20:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: In 2007, Omnitrope (R) was the first biosimilar recombinant human growth hormone (rhGH) to be approved in Sweden for treatment in adults and children. Over 10 years' safety and effectiveness data for biosimilar rhGH can now be presented.Methods: PATRO Children and PATRO Adults are multicenter, longitudinal, observational, post-marketing surveillance studies. Eligible patients include children 0-18 years and adults receiving biosimilar rhGH treatment. Adverse events (AEs) are monitored for safety evaluation. Growth variables in children and metabolic data in adults are recorded for effectiveness evaluation.Results: As of January 2019, data from 136 children (48% male) were reported from Swedish centers. Mean age in rhGH treatment-naive patients at study entry (n = 114) was 7.5 years, with mean 3.6 years treatment duration. No severe AEs of diabetes, impaired glucose tolerance, or malignancy were reported. The most frequently reported AE was nasopharyngitis (n = 16 patients). No clinically relevant anti-hGH or neutralizing antibodies were observed. The mean change from baseline in height standard deviation score (SDS) in naive prepubertal GH deficiency patients was + 0.79 at 1 year, + 1.27 at 2 years, and + 1.55 at 3 years. Data from 293 adults (44% rhGH-naive, 51% male) were included. Fatigue was the most frequently reported AE (n = 26 patients). The incidence of new neoplasms or existing neoplasm progression was 23.8 patients per 1000 patient-years. Type 2 diabetes mellitus was reported in four patients. At baseline in rhGH-naive adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m(2) and mean (SD) insulin-like growth factor (IGF)-I SDS was - 3.0 (1.4). Mean daily dose increased from 0.1 mg at baseline to 0.3 mg after 4 years. IGF-I SDS normalized during the first year of treatment. Mean BMI and glucose were unchanged over 4 years, while low-/high-density lipoprotein cholesterol ratio decreased.Conclusions: For the first time, Swedish data from the PATRO Children and Adults studies are presented. The 10-year data suggest that biosimilar rhGH is well tolerated across pediatric and adult indications. Safety and effectiveness were similar to previous reports for other rhGH preparations. These results need to be confirmed in larger cohorts, highlighting the importance of long-term post-marketing studies.
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