Modified-Release Hydrocortisone to Provide Circadian Cortisol Profiles

Debono, Miguel; Ghobadi, Cyrus; Rostami‐Hodjegan, Amin; Huatan, Hiep; Campbell, Mike; Newell‐Price, John; Darzy, Ken; Merke, Deborah P.; Arlt, Wiebke; Ross, Richard

doi:10.1210/jc.2008-2380

Cited by 263 publications

(228 citation statements)

References 31 publications

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“…We took especially care for a rigid time schedule: to avoid diurnal variations of cortisol (Hanson et al, 2000), all participants started the second experimental procedure at the same hour as the first experimental procedure. Because cortisol secretion remains reasonable steady in the late afternoon (Debono et al, 2009), all volunteers were stimulated in the afternoon within the same time frame between 16:00 and 18:00. In practice, if a given volunteer was stimulated at 17:00 at the first run, she was stimulated again at 17:00 on the second run.…”

Section: Hf-rtms Experimentsmentioning

confidence: 99%

One left dorsolateral prefrontal cortical HF-rTMS session attenuates HPA-system sensitivity to critical feedback in healthy females

Baeken¹,

Vanderhasselt²,

Remue³

et al. 2014

Neuropsychologia

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Abstract Abstract 2Objective: Although left dorsolateral prefrontal cortical (DLPFC) repetitive Transcranial Magnetic Stimulation (rTMS) is used to treat major depression, its underlying neurophysiological working mechanism remains to be determined. Prior research suggested that the clinical effects could be mediated by affecting the hypothalamic-pituitary-adrenal (HPA) system, but experimental studies in healthy individuals did not yield clear results. However, in healthy individuals, the influence of HFrTMS on the HPA-system may only be detected when it is challenged.Methods: In 30 rTMS naïve healthy females we evaluated the effect of one sham-controlled high frequency (HF)-rTMS session applied to the left DLPFC on the stress hormone cortisol by collecting salivary cortisol samples. In order to increase stress levels, five minutes after stimulation, all participants performed the Critical Feedback Task (CFT), during which they were criticized on their performance. To take possible mood influences into account, all participants were also assessed with Visual Analogue Scales (VAS).Results: The experimental procedure did not affect mood differently in the real or sham stimulation.Area under the curve (AUCi) analysis showed that one real HF-rTMS session significantly influenced HPA-system sensitivity, as demonstrated by a decrease in cortisol concentrations. The sham procedure yielded no effects.Conclusions: In line with former observations in major depression, one real left DLPFC HF-rTMS session significantly influenced HPA-system sensitivity in experimentally stressed females, resulting in decreases in cortisol levels.

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Section: Hf-rtms Experimentsmentioning

confidence: 99%

One left dorsolateral prefrontal cortical HF-rTMS session attenuates HPA-system sensitivity to critical feedback in healthy females

Baeken¹,

Vanderhasselt²,

Remue³

et al. 2014

Neuropsychologia

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“…One reason for impaired subjective health may be that common replacement regimens are not able to mimic the physiological diurnal pattern of cortisol secretion (1). This might be overcome by promising new developments of time-released medication (17,18). In addition, subjective health may also be affected by multiple aspects of SAI such as the mere fact of having a chronic disease, the need for chronic medication, or working disability (7,19).…”

Section: Sai Patients (Nz18)mentioning

confidence: 99%

Effects of standard glucocorticoid replacement therapies on subjective well-being: a randomized, double-blind, crossover study in patients with secondary adrenal insufficiency

Benson¹,

Neumann

Unger

et al. 2012

European Journal of Endocrinology

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Objective: For secondary adrenal insufficiency (SAI), established biochemical parameters for dosage control are lacking and no optimal substitution dosage and daily distribution have been determined yet. Therefore, in clinical practice, the individual total dose is often adjusted based on patients' subjective well-being. Design: Effects of three standard glucocorticoid replacement regimens on psychological variables were assessed in patients with SAI based on a randomized double-blind study design. Methods: SAI patients (nZ18) were treated with three different established glucocorticoid replacement regimens in a randomized, double-blind, crossover study (treatment A, hydrocortisone 10 mg-placebo-5 mg-placebo; treatment B, hydrocortisone 10 mg-5 mg-placebo-5 mg; and treatment C, prednisone 5 mg-placebo-placebo-placebo). Following each 4-week replacement regimen, quality of life (SF-36) and emotional distress (brief symptom inventory (BSI)) were assessed along with diurnal changes in current well-being (Bf-S) and alertness (Stanford Sleepiness Scale (SSS)) using validated questionnaires, and additionally compared with patient (patients with pituitary disease and adrenal sufficiency) and healthy control groups. Results: SAI patients showed improvements in physical quality of life (i.e. SF-36 physical function, P!0.05; physical role function, P!0.05) and current well-being (at 1800 h, P!0.05) under treatment A (hydrocortisone 10-0-5-0 mg) compared with the other replacement regimens. Quality of life and current well-being were significantly impaired compared with healthy controls but did not differ from patient controls. Conclusions: Although the observed improvements in psychological parameters were comparatively small, our results indicate beneficial effects of a 10-0-5-0 mg hydrocortisone replacement regimen. Nevertheless, treatment effects were insufficient to restore subjective health compared with healthy controls, indicating the need for improved replacement regimens and supportive psychosocial interventions in SAI patients.

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“…In the unstressed subject, cortisol has a distinct circadian rhythm: high on waking and low on going to sleep (3). In contrast, surgery stimulates both the endocrine and immune systems to mount a systemic reaction to the associated injury as part of the healing process and cortisol levels may increase to 830-1400 nmol/l, with phase shifting of the physiological rhythm depending on the degree of surgical stress (4,5).…”

Section: Introductionmentioning

confidence: 99%

Assessing adrenal status in patients before and immediately after coronary artery bypass graft surgery

Debono¹,

Sheppard²,

Irving³

et al. 2011

European Journal of Endocrinology

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Objective: Patients with cortisol deficiency poorly tolerate any systemic inflammatory response syndrome (SIRS), and may die if not treated with sufficient exogenous glucocorticoids. Controversy surrounds what constitutes a 'normal' adrenal response in critical illness. This study uses conventional tests for adrenal insufficiency to investigate cortisol status in patients undergoing elective coronary artery bypass surgery, a condition frequently associated with SIRS. Design: A prospective, observational study. Methods: Thirty patients with impaired left ventricular function (ejection fraction O23% !50%) underwent basal ACTH measurement, and a short cosyntropin test (250 mg, i.v.) 1 week preoperatively, and at C4 h following induction of general anaesthesia. Preoperatively, a 30 min cortisol level post cosyntropin O550 nmol/l was taken as a normal response. Results: Prior to surgery, all patients had a normal response to cosyntropin. Postoperatively, eight patients (26.7%) did not achieve stimulated cortisol levels O550 nmol/l and the mean peak cortisol postoperatively was lower (1048 vs 730 nmol/l; P!0.001). There was a significant rise in ACTH after surgery (21 vs 184 ng/l; PZ0.007) and reduction in D-cortisol post cosyntropin (579 vs 229 nmol/l; P!0.001). There was no change in basal cortisol pre-and post-operatively (447 vs 501; PZ0.4). All patients underwent routine, uneventful postoperative recovery. Conclusion: Up to one quarter of patients with a normal cortisol status preoperatively demonstrated a raised ACTH and deficient cortisol response postoperatively. Despite these responses, all patients had uneventful outcomes. These data reinforce the need for caution when interpreting results of endocrine testing following major surgery or in the intensive care environment, and that prognostic value of these results may be of limited use.

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Modified-Release Hydrocortisone to Provide Circadian Cortisol Profiles

Abstract: By defining circadian rhythms and using modern formulation technology, it is possible to allow a more physiological circadian replacement of cortisol.

Cited by 263 publications

References 31 publications

One left dorsolateral prefrontal cortical HF-rTMS session attenuates HPA-system sensitivity to critical feedback in healthy females

One left dorsolateral prefrontal cortical HF-rTMS session attenuates HPA-system sensitivity to critical feedback in healthy females

Effects of standard glucocorticoid replacement therapies on subjective well-being: a randomized, double-blind, crossover study in patients with secondary adrenal insufficiency

Assessing adrenal status in patients before and immediately after coronary artery bypass graft surgery

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