Variation of the baseline characteristics and treatment parameters over time: An analysis of 15 years of growth hormone replacement in adults in the German KIMS database

被引:2
作者
I. Kreitschmann-Andermahr
S. Siegel
F. Francis
M. Buchfelder
H. J. Schneider
P. H. Kann
H. Wallaschofski
M. Koltowska-Häggström
G. Brabant
机构
[1] Department of Neurosurgery, RWTH Aachen University, 52074 Aachen
[2] Department of Neurosurgery, University of Erlangen, 91054 Erlangen
[3] Department of Medicine, University of Munich Innenstadt, 80336 Munich
[4] Division of Endocrinology and Diabetology, Philipp's University Marburg, 35043 Marburg, Baldingerstraße
[5] Metabolic Center, Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, 17495 Greifswald, F.-Sauerbruch-Str.
[6] Pfizer Endocrine Care, Pfizer Inc.
[7] Department of Endocrinology, Christie, University of Manchester, University of Lübeck, 23538 Lübeck
关键词
Gender; Growth hormone deficiency; Pituitary disease; Time differences;
D O I
10.1007/s11102-012-0410-z
中图分类号
学科分类号
摘要
The purpose of this study is to examine potential implications of changes in the approach to adult growth hormone (GH) replacement (GHR) over the last 15 years. Therefore, we analysed the German KIMS database as one of the largest single country pharmacoepidemiological databases on adult GH deficiency (GHD). Based on the date of their first GH application patients were assigned to three intervals (1995-1999, 2000-2004, 2005-2009). A multivariate analysis of variance with interval and sex as independent variables was conducted. Differences were analysed with respect to IGF-I standard deviation score (SDS), quality of life, latency between GHD diagnosis and first GH dose, body mass index, waist-hip ratio, lipid profile, and GH dose. All analyses were conducted at baseline, 1 year, and 3 years of GHR. We detected significant associations between time interval and patient characteristics at baseline and with treatment effects. Recently, patients with less severe GHD (mean IGF-I SDS: -2.1, -1.6, -1.0 in the 1st, 2nd and 3rd interval; p = 0.000) are treated with lower GH starting doses (mean 0.30, 0.19, 0.21 mg/day in the 1st, 2nd and 3rd interval; p = 0.000). In the first time interval, IGF-I SDS was not normalized in females after 3 years of GHR. The results of our analysis demonstrate prominent changes in patient characteristics and handling of GHR. They highlight that approach to therapy and patient inclusion criteria change over time and may represent an important confounder for any analysis in epidemiological surveillance surveys. © 2012 Springer Science+Business Media, LLC.
引用
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页码:S72 / S80
页数:8
相关论文
共 27 条
[1]
Consensus guidelines for the diagnosis and treatment of adults with growth hormone deficiency: Summary statement of the Growth Hormone Research Society Workshop on Adult Growth Hormone Deficiency, J Clin Endocrinol Metab, 83, 2, pp. 379-381, (1998)
[2]
Ho K.K., Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II: A statement of the GH Research Society in association with the European Society for Pediatric Endocrinology, Lawson Wilkins Society, European Society of Endocrinology, Japan Endocrine Society, and Endocrine Society of Australia, Eur J Endocrinol, 157, 6, pp. 695-700, (2007)
[3]
Gutierrez L.P., Koltowska-Haggstrom M., Jonsson P.J., Mattsson A.F., Svensson D., Westberg B., Luger A., Registries as a tool in evidence-based medicine: Example of KIMS (Pfizer International Metabolic Database), Pharmacoepidemiol Drug Saf, 17, 1, pp. 90-102, (2008)
[4]
Bengtsson B.A., Eden S., Lonn L., Kvist H., Stokland A., Lindstedt G., Bosaeus I., Tolli J., Sjostrom L., Isaksson O.G., Treatment of adults with growth hormone (GH) deficiency with recombinant human GH, J Clin Endocrinol Metab, 76, 2, pp. 309-317, (1993)
[5]
Salomon F., Cuneo R.C., Hesp R., Sonksen P.H., The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency, N Engl J Med, 321, 26, pp. 1797-1803, (1989)
[6]
Kelestimur F., Jonsson P., Molvalilar S., Gomez J.M., Auernhammer C.J., Colak R., Koltowska-Haggstrom M., Goth M.I., Sheehan's syndrome: Baseline characteristics and effect of 2 years of growth hormone replacement therapy in 91 patients in KIMS-Pfizer International Metabolic Database, Eur J Endocrinol, 152, 4, pp. 581-587, (2005)
[7]
Maiter D., Abs R., Johannsson G., Scanlon M., Jonsson P.J., Wilton P., Koltowska-Haggstrom M., Baseline characteristics and response to GH replacement of hypopituitary patients previously irradiated for pituitary adenoma or craniopharyngioma: Data from the Pfizer International Metabolic Database, Eur J Endocrinol, 155, 2, pp. 253-260, (2006)
[8]
Kreitschmann-Andermahr I., Poll E.M., Reineke A., Gilsbach J.M., Brabant G., Buchfelder M., Fassbender W., Faust M., Kann P.H., Wallaschofski H., Growth hormone deficient patients after traumatic brain injury-baseline characteristics and benefits after growth hormone replacement-an analysis of the German KIMS database, Growth Horm IGF Res, 18, 6, pp. 472-478, (2008)
[9]
Spielhagen C., Schwahn C., Moller K., Friedrich N., Kohlmann T., Moock J., Koltowska-Haggstrom M., Nauck M., Buchfelder M., Wallaschofski H., The benefit of long-term growth hormone (GH) replacement therapy in hypopituitary adults with GH deficiency: Results of the German KIMS database, Growth Horm IGF Res, 21, 1, pp. 1-10, (2011)
[10]
Brabant G., Poll E.M., Jonsson P., Polydorou D., Kreitschmann-Andermahr I., Etiology, baseline characteristics, and biochemical diagnosis of GH deficiency in the adult: Are there regional variations?, Eur J Endocrinol, 161, SUPPL. 1, (2009)