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Complete Thesis University of Groningen Hydrocortisone dose in adrenal insufficiency Werumeus Buning, Jorien IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2017 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Werumeus Buning, J. (2017). Hydrocortisone dose in adrenal insufficiency: Balancing harms and benefits. Rijksuniversiteit Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 26-09-2021 HYDROCORTISONE DOSE IN ADRENAL INSUFFICIENCY Balancing harms and benefits Jorien Werumeus Buning Hydrocortisone dose in adrenal insufficiency Balancing harms and benefits Thesis, University of Groningen, the Netherlands Cover-design: Machteld Hardick – www.mhardick.nl Lay-out: Ridderprint BV – www.ridderprint.nl Printing: Ridderprint BV – www.ridderprint.nl ISBN: 978-90-367-9699-6 (printed) 978-90-367-9698-9 (eBook) Copyright © 2017 Jorien Werumeus Buning All rights reserved. No parts of this thesis may be reproduced, stored in retrieval system, or transmitted in any form or by any means without prior written permission of the author. Financial support for the printing of this thesis is kindly provided by The Endocrinol- ogy Fund (as part of the Ubbo Emmius Fund), Goodlife Healthcare BV, Pfizer BV, Novartis Pharma BV, Graduate School of Medical Sciences/University Medical Center Groningen and University of Groningen. Hydrocortisone dose in adrenal insufficiency Balancing harms and benefits Proefschrift ter verkrijging van de graad van doctor aan de Rijksuniversiteit Groningen op gezag van de rector magnificus prof. dr. E. Sterken en volgens besluit van het College voor Promoties. De openbare verdediging zal plaatsvinden op maandag 8 mei 2017 om 16.15 uur door Jorien Werumeus Buning geboren op 29 december 1987 te Steenwijk, Nederland Promotores Prof. dr. B.H.R. Wolffenbuttel Prof. dr. O.M. Tucha Copromotores Dr. A.P. van Beek Dr. J. Koerts Beoordelingscommissie Prof. dr. A.R.M.M. Hermus Prof. dr. O.C. Meijer Prof. dr. B.R. Walker Paranimfen H.E. Koning R. Werumeus Buning Contents Chapter 1 Introduction and aims of the thesis 9 Part I The effect of hydrocortisone treatment on psychological outcome measures in patients with secondary adrenal insufficiency Chapter 2 The effect of two different doses of hydrocortisone on cognition 29 in patients with secondary adrenal insufficiency – results from a randomized controlled trial. Psychoneuroendocrinology 2015;55:36–47 Chapter 3 Hydrocortisone dose influences pain, depressive symptoms and 63 perceived health in adrenal insufficiency: a randomized controlled trial. Neuroendocrinology 2016;103(6):771–8 Chapter 4 The role of cortisol in the association between perceived stress and 87 pain: a short report on secondary adrenal insufficient patients. Journal for Person-Oriented Research 2016;2(3):135–141 Part II The effect of hydrocortisone treatment on somatic outcome measures in patients with secondary adrenal insufficiency Chapter 5 Somatosensory functioning in patients with secondary adrenal 101 insufficiency treated with two different doses of hydrocortisone – results from a randomized controlled trial. Submitted Chapter 6 Effects of hydrocortisone on the regulation of blood pressure – 115 results from an RCT. Journal of Clinical Endocrinology & Metabolism 2016;101(10):3691–3699 Chapter 7 Pharmacokinetics of hydrocortisone: results and implications from 141 a randomized controlled trial. Accepted in Metabolism Chapter 8 General discussion and future perspectives 165 Chapter 9 Summary 185 Samenvatting 193 Dankwoord 201 About the author 207 List of publications 211 Chapter 1 Introduction and aims of the thesis Introduction 11 The hypothalamic-pituitary-adrenal axis 1 The hypothalamic-pituitary-adrenal (HPA) axis functions through a complex set of interactions between the hypothalamus, the pituitary and the adrenal glands. It is our central stress response system which is activated during physically or mentally challenging situations. Activation of the system causes the hypothalamus to secrete corticotrophin releasing hormone (CRH). When CRH binds to CRH receptors on the anterior pituitary gland, adrenocorticotropic hormone (ACTH) is released by the pitu- itary. ACTH stimulates the secretion of cortisol by the adrenal cortex. Cortisol, in turn, exerts inhibitory effects to the hypothalamus and the pituitary via a negative feedback loop (Figure 1). Cortisol secretion shows strong diurnal variation with the lowest levels at around midnight, an initiation of the rise at approximately 02.00–03.00 h and peak values in the morning directly after waking. Thereafter, levels slowly decrease throughout the day until the nadir at midnight. Besides being activated during stressful situations, the HPA axis is also vital for sup- porting normal physiological functioning. Cortisol serves several functions in the body like the regulation of blood glucose, suppression of the immune system and assistance in fat, protein and carbohydrate metabolism. Adrenal insufficiency Patients with adrenal insufficiency (AI) are characterized by the loss of endogenous cortisol production. This lack of cortisol production can be caused by loss of function of the adrenal gland itself, in which case it is called primary AI (PAI) (Figure 1). This form of AI is most frequently caused by autoimmune adrenalitis (Addison’s disease) or by a disturbed function of one of the enzymes involved in cortisol synthesis (con- genital adrenal hyperplasia).1,2 AI can also be caused by impairment of the pituitary (secondary AI (SAI)) or hypothalamus (tertiary AI), resulting in a deficiency of ACTH or CRH, respectively, and subsequently a lack of stimulation of the adrenal cortex to produce cortisol. Pituitary tumors or treatment of these pituitary tumors, by means of pituitary surgery or radiotherapy, are the most frequent causes of SAI.3 Pituitary tumors can be classified as functioning or non-functioning, depending on their hormonal activity. Non-functioning adenomas have no clinical or biochemical features of excessive hormonal secretion, whereas functional pituitary adenomas are characterized by excessive pituitary hormonal secretion. Other pituitary region tumors, such as craniopharyngiomas, meningeomas, germinomas, intrasellar or suprasellar metastases as well as traumatic brain injury can also cause SAI.4 The first choice of treatment of pituitary (region) tumors is surgical resection of the tumor, usually via 12 Chapter 1 Figure 1. The hypothalamus-pituitary-adrenal axis during A) the normal physiological situation, B) with primary adrenal insufficiency, C) with secondary adrenal insufficiency and D) with tertiary adrenal insufficiency. Introduction 13 the transsphenoidal route. It is a minimally invasive technique in which the tumor is approached through the nose and sphenoid sinus. Less commonly, when the tumor 1 is large or is not accessible through the transsphenoidal route, transcranial surgery is performed, in which a section of the skull is removed in order to access the brain. In some cases additional radiotherapy is applied, for instance when the tumor is not fully resected, when the tumor is recurring or in case of secreting adenomas where hormonal control cannot be achieved after surgery and medical therapy. SAI is a rare disease, it has an estimated prevalence of 150–280 per million.3,5–7 Patients with untreated SAI present with weight loss, anorexia or loss of appetite, generalized fatigue, loss of energy, reduced muscle strength, and increased irritability.4 However, presenting signs and symptoms are often subtle and unspecific, impeding the diagnosis which often leads to a delay in diagnosis. Diagnosis The diagnosis of SAI is based on the finding of low early morning cortisol levels. Furthermore, in case of indeterminate cortisol values, various stimulation tests are available to assess the integrity of the HPA axis. For instance, the ACTH stimulation test, also known as the short synacthen test, has been advocated by several investiga- tors in cases with a suspected disease duration of at least one month. This test can be done at any time of the day. Serum cortisol levels are measured at baseline and 30 or 60 minutes after the administration of 250 µg ACTH. Cortisol responses below 500–550 nmol/L (specific cut-off values can vary, depending on the assay used for the measure- ment of cortisol) are indicative of AI. However, when performed within 4 weeks after pituitary surgery, the adrenal glands are not yet atrophied and thus may still respond to ACTH, wrongly indicating intact HPA axis. Therefore, the insulin tolerance test is the gold standard for the diagnosis of SAI. In this test, a hypoglycemic state is provoked by the administration of 0.1 units of insulin/ kg body weight.
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