Abstract:
PURPOSE:PATRO adults is an ongoing, multicenter, observational, post-marketing surveillance study aimed at investigating the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the recombinant human growth hormone (rhGH) Omnitrope® during routine clinical practice. This report describes data from Italian participants in PATRO Adults with growth hormone deficiency (GHD), up to August 2017. METHODS:Participants were adults (aged > 18 years) with GHD requiring rhGH therapy and were prescribed Omnitrope®, including those who had previously received another rhGH product. Adverse events (AEs) were evaluated in all study participants. Data were collected on insulin-like growth factor (IGF)-I levels and cardiovascular risk factors, including blood pressure, lipids, and anthropometric parameters. RESULTS:From September 2007 to August 2017, 88 patients (mean age 48.9 years, 58.0% male) were enrolled at 8 sites in Italy. The mean treatment duration with Omnitrope® was 51.5 ± 37 months. AEs occurred in 54 patients; the most common were asthenia (20.5%), headache (14.8%), and arthralgia (13.6%). Serious AEs occurred in 22 patients (25%), including pneumonia (n = 2) and renal failure (n = 2). Neoplasms (2 benign and 1 malignant) developed in three patients, but none were considered to be drug-related. There were no significant changes in fasting glucose or glycosylated hemoglobin (HbA1c) during the study period. Long-term Omnitrope® therapy showed slight positive effects on lipid profile, while no significant changes were observed in body weight and BMI during the study. CONCLUSION:This snapshot analysis of Italian participants in PATRO Adults confirmed the long-term safety and effectiveness of Omnitrope® in adults with GHD.
journal_name
J Endocrinol Investjournal_title
Journal of endocrinological investigationauthors
Arosio M,Arnaldi G,Gasco V,Giavoli C,Puxeddu E,Vettor R,Ambrosio MR,Gallinari P,Zouater H,Fedeli P,Ferone Ddoi
10.1007/s40618-020-01308-3subject
Has Abstractpub_date
2021-02-01 00:00:00pages
327-337issue
2eissn
0391-4097issn
1720-8386pii
10.1007/s40618-020-01308-3journal_volume
44pub_type
杂志文章abstract::The renin-angiotensin-aldosterone system (RAAS) plays a well-recognized role in the regulation of BP and in salt and water balance. Since hypertension affects a considerable proportion of obese patients, circulating RAAS has been studied in obese subjects with and without hypertension, albeit with conflicting results....
journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03344010
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abstract::No head-to-head comparisons are available to analyze the efficacy of octreotide (LAR) and lanreotide (LAN) as first-line treatment of acromegaly.We compared the efficacy of these two drugs in 54 newly diagnosed patients (21 women, 33 men), 27 treated with LAR (10-30 mg every 28 days) and 27 with LAN (60-90 mg/28 days)...
journal_title:Journal of endocrinological investigation
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journal_title:Journal of endocrinological investigation
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journal_title:Journal of endocrinological investigation
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journal_title:Journal of endocrinological investigation
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journal_title:Journal of endocrinological investigation
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03350313
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03346945
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journal_title:Journal of endocrinological investigation
pub_type: 临床试验,杂志文章
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03349057
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03350921
更新日期:1988-11-01 00:00:00
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/s40618-014-0061-1
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03350502
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章,评审
doi:10.1007/BF03345815
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03348447
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abstract::Eight-year follow-up evaluation and analysis of factors related to postoperative thyroid dysfunction were made in 216 patients with Graves' disease treated by subtotal thyroidectomy. The postoperative status of thyroid function were as follows according to hypersensitive TSH level: 65 patients (30.1%) were euthyroid, ...
journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03344945
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03349385
更新日期:1980-10-01 00:00:00
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03345528
更新日期:2005-01-01 00:00:00
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03350515
更新日期:1982-09-01 00:00:00
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03349528
更新日期:1990-02-01 00:00:00
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章,评审
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journal_title:Journal of endocrinological investigation
pub_type: 杂志文章
doi:10.1007/BF03347283
更新日期:1998-01-01 00:00:00
abstract::Somatostatin has been found in the pineal gland of several animal species, which suggests that it may be involved in the regulation of melatonin secretion. Whether somatostatin has regulatory influence on melatonin secretion in man has never been unequivocally shown. We studied the nocturnal melatonin secretion in 8 h...
journal_title:Journal of endocrinological investigation
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1999-07-01 00:00:00