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Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency.
MedLine Citation:
PMID:  23148199     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To describe the rationale and design of PATRO Adults, a postmarketing surveillance study of the long-term efficacy and safety of somatropin (Omnitrope(®)) for the treatment of adult patients with growth hormone deficiency (GHD).
METHODS: PATRO Adults is an observational, multicentre, open, longitudinal, noninterventional study being conducted in hospitals and specialized endocrinology clinics across several European countries. The primary objective is to assess the safety and efficacy of Omnitrope(®) in adults treated in routine clinical practice. Eligible patients are male or female adults who are receiving treatment with Omnitrope(®) and who have provided informed consent. Patients who have been treated with another human growth hormone (hGH) product before starting Omnitrope(®) therapy will also be eligible for inclusion. Efficacy assessments will be based on the analysis of the following: insulin-like growth factor-1 levels within age- and gender-adjusted normal ranges; anthropometric measures (weight, waist circumference, total fat mass, lean body mass, total body water); bone mineral density; lipids; effects on cardiovascular risk factors such as glucose metabolism, blood pressure and inflammatory markers (e.g. C-reactive protein); and quality of life. All adverse events will be monitored and recorded. Particular emphasis will be placed on long-term safety, the recording of malignancies, the occurrence and clinical impact of antirecombinant hGH antibodies, the incidence, severity and duration of hyperglycaemia, and the development of diabetes during treatment with Omnitrope(®).
CONCLUSIONS: PATRO Adults is a large, long-term, postmarketing surveillance study that will extend the safety database for Omnitrope(®), as well as contributing to the available data for all recombinant hGH products. Of particular interest, the study will provide important data on the impact of long-term GH replacement therapy on the development of diabetes mellitus, the recurrence/regrowth of hypothalamic-pituitary tumours, and de novo malignancy or recurrence of other (non-hypothalamic-pituitary) tumours.
Authors:
Paolo Beck-Peccoz; Francesco Minuto; Alfonso Leal-Cerro; Markus Zabransky; Günter Stalla
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Therapeutic advances in endocrinology and metabolism     Volume:  3     ISSN:  2042-0196     ISO Abbreviation:  Ther Adv Endocrinol Metab     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-11-13     Completed Date:  2012-11-19     Revised Date:  2013-05-30    
Medline Journal Info:
Nlm Unique ID:  101532143     Medline TA:  Ther Adv Endocrinol Metab     Country:  United States    
Other Details:
Languages:  eng     Pagination:  85-91     Citation Subset:  -    
Affiliation:
Endocrinology and Diabetology Unit, Medical Sciences Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.
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