Abstract:
BACKGROUND:To evaluate the impact of treatment with recombinant human growth hormone (rhGH; Omnitrope®) on the risk of diabetes mellitus in adults with growth hormone deficiency (GHD), using data from the ongoing PATRO Adults post-marketing surveillance study. METHODS:PATRO Adults is an ongoing post-marketing surveillance study being conducted in hospitals and specialized endocrinology clinics across Europe. All enrolled patients who receive ≥1 dose of Omnitrope® are included in the safety population. Patient profiles, containing all available study database information for each specific patient, were generated for all patients with adverse events (AEs) of diabetes mellitus while participating in the study. Diabetes mellitus was confirmed if fasting plasma glucose was ≥7.0 mmol/L or 2-h plasma glucose ≥11.1 mmol/L during oral glucose tolerance test or glycated hemoglobin ≥6.5%. RESULTS:Up to July 2018, 1293 patients had been enrolled in the study, and 983 (76.0%) remained active. Just under half (n = 687, 49.3%) of the patients were growth hormone (GH) treatment-naïve on entering the study, and most (n = 1128, 87.2%) had multiple pituitary hormone deficiency (MPHD). Diabetes mellitus/inadequate control (worsening) of diabetes mellitus was reported in 21 patients (22 events). The cases were newly diagnosed in 15 patients (age 29-84 years; incidence rate 3.61 per 1000 patient-years) and occurred in 6 patients with pre-existing diabetes mellitus at baseline (age 45-72 years). Most cases of newly diagnosed diabetes mellitus occurred in patients with adult-onset MPHD (n = 13); the remaining cases of new-onset diabetes mellitus occurred in a patient with childhood-onset MPHD who had previously received GH replacement therapy (n = 1), and a patient with adulthood-onset isolated GHD who was naïve to GH replacement therapy (n = 1). All cases of inadequate control/worsening of diabetes mellitus occurred in patients with adult-onset MPHD. CONCLUSIONS:Based on this snapshot of data from PATRO Adults, Omnitrope® treatment is tolerated in adult patients with GHD in a real-life clinical practice setting. No signals of an increased risk for diabetes mellitus have been noted so far, although continued follow-up (both during and after rhGH therapy) is required to confirm this. TRIAL REGISTRATION:Not applicable.
journal_name
BMC Endocr Disordjournal_title
BMC endocrine disordersauthors
Beck-Peccoz P,Höybye C,Murray RD,Simsek S,Zabransky M,Zouater H,Stalla Gdoi
10.1186/s12902-019-0464-2subject
Has Abstractpub_date
2019-12-11 00:00:00pages
138issue
1issn
1472-6823pii
10.1186/s12902-019-0464-2journal_volume
19pub_type
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abstract:BACKGROUND:The pathophysiology of type2 diabetes involves both insulin resistance and poor beta cell function. Studies have been done in several populations to assess the relative importance of these mechanisms in individual patients. In our environment studies to assess beta cell function have been done with glucagon ...
journal_title:BMC endocrine disorders
pub_type: 杂志文章
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abstract:BACKGROUND:Down syndrome (DS) has been described as one of the main contributors for low bone mineral density (BMD). Physical activity (PA) is a key factor in skeletal health and thus, PA levels might be associated to the risk of developing osteoporosis. Therefore, the aims were (1) to describe PA patterns in adolescen...
journal_title:BMC endocrine disorders
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journal_title:BMC endocrine disorders
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pub_type: 杂志文章
doi:10.1186/1472-6823-9-16
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pub_type: 杂志文章
doi:10.1186/s12902-018-0232-8
更新日期:2018-01-27 00:00:00
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pub_type: 杂志文章,meta分析,评审
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
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journal_title:BMC endocrine disorders
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pub_type: 杂志文章
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
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journal_title:BMC endocrine disorders
pub_type: 杂志文章
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更新日期:2010-05-17 00:00:00
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pub_type: 杂志文章,meta分析
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pub_type: 杂志文章,meta分析
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