Sökning: onr:"swepub:oai:DiVA.org:umu-187366" >
Safety and Effectiv...
Safety and Effectiveness of Recombinant Human Growth Hormone in Children with Turner Syndrome : Data from the PATRO Children Study
-
Backeljauw, Philippe (författare)
-
Kanumakala, Shankar (författare)
-
Loche, Sandro (författare)
-
visa fler...
-
Schwab, Karl Otfried (författare)
-
Pfäffle, Roland Werner (författare)
-
- Höybye, Charlotte (författare)
- Karolinska Institutet
-
- Lundberg, Elena, 1961- (författare)
- Umeå universitet,Pediatrik
-
Battelino, Tadej (författare)
-
- Kriström, Berit (författare)
- Umeå universitet,Pediatrik
-
Giemza, Tomasz (författare)
-
Zouater, Hichem (författare)
-
visa färre...
-
(creator_code:org_t)
- 2021-07-07
- 2021
- Engelska.
-
Ingår i: Hormone Research in Paediatrics. - : S. Karger. - 1663-2818 .- 1663-2826. ; 94:3-4, s. 133-143
- Relaterad länk:
-
https://doi.org/10.1...
-
visa fler...
-
https://umu.diva-por... (primary) (Raw object)
-
https://www.karger.c...
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
http://kipublication...
-
visa färre...
Abstract
Ämnesord
Stäng
- 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
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Nyckelord
- Turner syndrome
- Pediatric endocrinology
- Growth hormone replacement therapy
- PATRO Children
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Backeljauw, Phil ...
-
Kanumakala, Shan ...
-
Loche, Sandro
-
Schwab, Karl Otf ...
-
Pfäffle, Roland ...
-
Höybye, Charlott ...
-
visa fler...
-
Lundberg, Elena, ...
-
Battelino, Tadej
-
Kriström, Berit
-
Giemza, Tomasz
-
Zouater, Hichem
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Pediatrik
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Endokrinologi oc ...
- Artiklar i publikationen
-
Hormone Research ...
- Av lärosätet
-
Umeå universitet
-
Karolinska Institutet