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Florian Schederecker Institute of Epidemiology, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Neuherberg, Germany

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Alexander Cecil Molecular Endocrinology and Metabolism, Genome Analysis Center, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany

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Cornelia Prehn Molecular Endocrinology and Metabolism, Genome Analysis Center, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany

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Jana Nano Institute of Epidemiology, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Neuherberg, Germany

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Wolfgang Koenig Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany
Deutsches Herzzentrum München, Technische Universität München, DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

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Jerzy Adamski Molecular Endocrinology and Metabolism, Genome Analysis Center, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany
Lehrstuhl für Experimentelle Genetik, Technische Universität München, Freising-Weihenstephan, Germany
Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore

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Tanja Zeller Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany

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Annette Peters Institute of Epidemiology, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Neuherberg, Germany
German Centre for Cardiovascular Research (DZHK), Partner Site Munich, Munich, Germany

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Barbara Thorand Institute of Epidemiology, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Neuherberg, Germany

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Objective

Sex hormone-binding globulin (SHBG) and androgens have been associated with mortality in women and men, but controversy still exists. Our objective was to investigate associations of SHBG and androgens with all-cause and cause-specific mortality in men and women.

Design

1006 men and 709 peri- and postmenopausal women (age range: 45–82 years) from the German population-based KORA F4 cohort study were followed-up for a median of 8.7 years.

Methods

SHBG was measured with an immunoassay, total testosterone (TT) and dihydrotestosterone (DHT) with mass-spectrometry in serum samples and we calculated free testosterone (cFT). To assess associations between SHBG and androgen levels and mortality, we calculated hazard ratios (HRs) with 95% CIs using Cox proportional-hazards models.

Results

In the cohort, 128 men (12.7%) and 70 women (9.9%) died. In women, we observed positive associations of SHBG with all-cause (HR: 1.54, 95% CI: 1.16–2.04) and with other disease-related mortality (HR: 1.86, 95% CI: 1.08–3.20) and for DHT with all-cause mortality (HR: 1.32, 95% CI: 1.00–1.73). In men, we found a positive association of SHBG (HR: 1.24 95% CI: 1.00–1.54) and inverse associations of TT (HR: 0.87, 95% CI: 0.77–0.97) and cFT (HR: 0.84, 95% CI: 0.73–0.97) with all-cause mortality. No other associations were found for cause-specific mortality.

Conclusions

Higher SHBG levels were associated with increased risk of all-cause mortality in men and women. Lower TT and cFT levels in men and higher DHT levels in women were associated with increased risk of all-cause mortality. Future, well-powered population-based studies should further investigate cause-specific mortality risk.

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Sonja Kunz Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Xiao Wang Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Uta Ferrari Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Michael Drey Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Marily Theodoropoulou Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Katharina Schilbach Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Martin Reincke Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Margit Heier Institute of Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany
KORA Study Centre, University Hospital of Augsburg, Augsburg, Augsburg, Germany

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Annette Peters Institute of Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany
German Centre for Cardiovascular Research (DZHK), Partner site Munich Heart Alliance, Munich, Germany

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Wolfgang Koenig German Centre for Cardiovascular Research (DZHK), Partner site Munich Heart Alliance, Munich, Germany
German Heart Centre Munich, Technical University of Munich, Munich, Germany
Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany

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Tanja Zeller Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Hamburg, Germany

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Barbara Thorand Institute of Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany

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Martin Bidlingmaier Department of Medicine IV, University Hospital, Ludwig Maximilian University Munich, Munich, Germany

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Objective

Measurements utilizing commercially available sets of reagents for determination of steroid hormone profiles by liquid chromatography–tandem mass spectrometry (LC-MS/MS) have become increasingly important for routine laboratories. However, method-specific publications of reference intervals obtained from sufficiently large studies are often missing.

Methods

After validation of performance characteristics, a widely available kit for steroid analysis by LC-MS/MS was used to measure concentrations of 15 endogenous steroids (aldosterone, cortisol, cortisone, corticosterone, 11-deoxycortisol, 21-deoxycortisol, dehydroepiandrosterone sulfate, estradiol, testosterone, androstenedione, dihydrotestosterone, dehydroepiandrosterone, 17-hydroxyprogesterone, 11-deoxycorticosterone, progesterone) in more than 500 blood samples from a population-based study. While randomly selected from a larger cohort, the samples equally represented both sexes and covered a wide range of adult age groups. Age- and sex-specific reference intervals were calculated, and correlation with BMI was assessed.

Results

Performance characteristics of the assay matched expectations for 9 of 15 steroids. For most of them, reference intervals obtained from our study population were comparable to those reported by others, with age and sex being the major determinants. A sex-specific correlation with BMI was found for seven steroids. We identified limitations regarding sensitivity of the method for quantification of progesterone in males and postmenopausal females. Concentrations of aldosterone, 21-deoxycortisol, estradiol, 11-deoxycorticosterone, and dihydrotestosterone could not be quantified in a large percentage of samples.

Conclusions

The reference intervals for nine steroids will support meaningful interpretation for steroid profiles as measured by a widely used kit for LC-MS/MS-based quantification. Laboratories using such kits must be aware of potential limitations in sensitivity for some steroids included in the profile.

Significance Statement

Quantification of steroid hormones is a cornerstone for diagnosis of several diseases. Commonly used immunoassays have limitations in specificity. Liquid chromatography–tandem mass spectrometry (LC-MS/MS) is a promising alternative, particularly if methods are harmonized across laboratories. The use of kits from commercial suppliers might support this. Clinical interpretation of steroid concentrations requires availability of appropriate reference intervals (RIs), but studies on RIs reported in the literature differ in preanalytical and analytical procedures. Here, we provide RIs for steroids measured by a widely available kit under preanalytical conditions mirroring common clinical practice. Such RIs might facilitate interpretation for those using the same method and comparable conditions in clinical routine.

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