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Mortality Is Not Increased in Recombinant Human Growth Hormone-treated Patients When Adjusting for Birth Characteristics
University of Gothenburg, Sweden.
University of Gothenburg, Sweden; Stat Konsultgrp, Sweden.
Karolinska University Hospital, Sweden; Karolinska University Hospital, Sweden.
University of Gothenburg, Sweden.
Vise andre og tillknytning
2016 (engelsk)Inngår i: Journal of Clinical Endocrinology and Metabolism, ISSN 0021-972X, E-ISSN 1945-7197, Vol. 101, nr 5, 2149-2159 s.Artikkel i tidsskrift (Fagfellevurdert) Published
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Abstract [en]

Objective: This study aimed to investigate whether reported high mortality in childhood recombinant human GH (rhGH)-treated patients was related to birth-characteristics and/or rhGH treatment. Design and Setting: We sought to develop a mortality model of the Swedish general population born between 1973 and 2010, using continuous-hazard functions adjusting for birth characteristics, sex, age intervals, and calendar year to estimate standardized mortality ratio (SMR) and to apply this model to assess expected deaths in Swedish rhGH-treated patients with idiopathic isolated GH deficiency (IGHD), idiopathic short stature (155) or born small for gestational age (SGA). Participants:The general population: Swedish Medical Birth Register (1973-2010: 1 880 668 males; 1 781 131 females) and Cause of Death Register (1985-2010). Intervention Population: Three thousand eight hundred forty-seven patients starting rhGH treatment between 1985 and 2010 and followed in the National GH Register and/or in rhGH trials diagnosed with IGHD (n = 1890), ISS (n = 975), or SGA (n=982). Main Outcome Measures: Death. Results: Using conventional models adjusting for age, sex, and calendar-year, the SMR was 1.43 (95% confidence interval, 0.89-2.19), P = .14, observed/expected deaths 21/14.68. The rhGH population differed (P amp;lt; .001) from the general population regarding birth weight, birth length, and congenital malformations. Application of an Advanced Model: When applying the developed mortality model of the general population, the ratio of observed/expected deaths in rhGH-treated patients was 21/21.99; SMR = 0.955 (0.591-1.456)P = .95. Model Comparison: Expected number of deaths were 14.68 (14.35-14.96) using the conventional model, and 21.99 (21.24-22.81) using the advanced model, P amp;lt; .001, which had at all ages a higher gradient of risk per SD of the model, 24% (range, 18-42%; P amp;lt; .001). Conclusions: Compared with the general Swedish population, the ratio of observed/expected deaths (21/21.99) was not increased in childhood rhGH-treated IGHD, ISS, and SGA patients when applying an advanced sex-specific mortality model adjusting for birth characteristics.

sted, utgiver, år, opplag, sider
ENDOCRINE SOC , 2016. Vol. 101, nr 5, 2149-2159 s.
HSV kategori
Identifikatorer
URN: urn:nbn:se:liu:diva-130304DOI: 10.1210/jc.2015-3951ISI: 000378819700032PubMedID: 26918292OAI: oai:DiVA.org:liu-130304DiVA: diva2:950496
Merknad

Funding Agencies|Swedish Research Council [7509]; Governmental University Hospital Research grants; West Region Research Grants; Foundation Vaxthuset for Children

Tilgjengelig fra: 2016-07-31 Laget: 2016-07-28 Sist oppdatert: 2017-02-24

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