Dual-release hydrocortisone treatment: glycometabolic profile and health-related quality of life

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Objective

Adrenal insufficiency (AI) is a chronic condition associated with increased mortality and morbidity. The treatment of AI in the last years has been object of important changes due to the development of a dual-release preparation of hydrocortisone. It differs from previous therapeutic strategy as it contemplates a once-daily tablet that allows more closely mimicking the physiological circadian cortisol rhythm. The aim of the study was to evaluate the effects of dual-release hydrocortisone treatment on the glycometabolic profile and health-related quality of life of patients with AI.

Design and Methods

In this clinical open trial, we enrolled ten patients with primary AI (41 ± 2.67 years) and nine patients with AI secondary to hypopituitarism (53.2 ± 17.7 years). We evaluated the glycometabolic profile before and 3, 6, 9 and 12 months after dual-release hydrocortisone administration. We also evaluated health-related quality of life, estimated by the AddiQol questionnaire. The mean dose administered of dual-release hydrocortisone was 28.33 ± 6.68 mg/day.

Results

One female hypopituitary patient dropped out from the study. After 12 months of treatment, the mean dosage administered of dual-release hydrocortisone was significantly lower ( P < 0.05) and all patients reported improved quality of life and well-being. The glycometabolic profile improved and the glycosylated hemoglobin decreased significantly in patients with primary AI (6.25 ± 0.2 vs 5.35 ± 0.17, P < 0.05). In contrast, hypopituitary patients had worse glycometabolic profile and a trend toward hypertriglyceridemia.

Conclusions

Dual-release hydrocortisone treatment improved the quality of life of patients with AI, and it allowed a decrease of cortisol dosage administered in the absence of side effects. The glycometabolic profile worsened in hypopituitary patients.

Related collections

Most cited references 16

Record: found
Abstract: found
Article: not found

Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies.

Manfred Ventz, Danijela Milovanovic, Martin Fassnacht … (2010)

Adrenal crisis (AC) is a life-threatening complication of adrenal insufficiency (AI). Here, we evaluated frequency, causes and risk factors of AC in patients with chronic AI. In a cross-sectional study, 883 patients with AI were contacted by mail. Five-hundred and twenty-six patients agreed to participate and received a disease-specific questionnaire. Four-hundred and forty-four datasets were available for analysis (primary AI (PAI), n=254; secondary AI (SAI), n=190). Forty-two percent (PAI 47% and SAI 35%) reported at least one crisis. Three hundred and eighty-four AC in 6092 patient years were documented (frequency of 6.3 crises/100 patient years). Precipitating causes were mainly gastrointestinal infection and fever (45%) but also other stressful events (e.g. major pain, surgery, psychic distress, heat and pregnancy). Sudden onset of apparently unexplained AC was also reported (PAI 6.6% and SAI 12.7%). Patients with PAI reported more frequent emergency glucocorticoid administration (42.5 vs 28.4%, P=0.003). Crisis incidence was not influenced by educational status, body mass index, glucocorticoid dose, DHEA treatment, age at diagnosis, hypogonadism, hypothyroidism or GH deficiency. In PAI, patients with concomitant non-endocrine disease were at higher risk of crisis (odds ratio (OR)=2.02, 95% confidence interval (CI) 1.05-3.89, P=0.036). In SAI, female sex (OR=2.18, 95% CI 1.06-4.5, P=0.035) and diabetes insipidus (OR=2.71, 95% CI 1.22-5.99, P=0.014) were associated with higher crisis incidence. AC occurs in a substantial proportion of patients with chronic AI, mainly triggered by infectious disease. Only a limited number of risk factors suitable for targeting prevention of AC were identified. These findings indicate the need for new concepts of crisis prevention in patients with AI.

0 comments Cited 115 times – based on 0 reviews      Review now

Record: found
Abstract: found
Article: not found

Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation.

G Johannsson, A G Nilsson, R Bergthorsdottir … (2012)

Patients with treated adrenal insufficiency (AI) have increased morbidity and mortality rate. Our goal was to improve outcome by developing a once-daily (OD) oral hydrocortisone dual-release tablet with a more physiological exposure-time cortisol profile. The aim was to compare pharmacokinetics and metabolic outcome between OD and the same daily dose of thrice-daily (TID) dose of conventional hydrocortisone tablets. We conducted an open, randomized, two-period, 12-wk crossover multicenter trial with a 24-wk extension at five university hospital centers. The trial enrolled 64 adults with primary AI; 11 had concomitant diabetes mellitus (DM). The same daily dose of hydrocortisone was administered as OD dual-release or TID. We evaluated cortisol pharmacokinetics. Compared with conventional TID, OD provided a sustained serum cortisol profile 0-4 h after the morning intake and reduced the late afternoon and the 24-h cortisol exposure. The mean weight (difference = -0.7 kg, P = 0.005), systolic blood pressure (difference = -5.5 mm Hg, P = 0.0001) and diastolic blood pressure (difference: -2.3 mm Hg; P = 0.03), and glycated hemoglobin (absolute difference = -0.1%, P = 0.0006) were all reduced after OD compared with TID at 12 wk. Compared with TID, a reduction in glycated hemoglobin by 0.6% was observed in patients with concomitant DM during OD (P = 0.004). The OD dual-release tablet provided a more circadian-based serum cortisol profile. Reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during OD treatment. In particular, glucose metabolism improved in patients with concomitant DM.

0 comments Cited 103 times – based on 0 reviews      Review now

Record: found
Abstract: found
Article: not found

Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis.

Jutta Loeffler, Marcus Quinkler, Martin Fassnacht … (2007)

There is mounting evidence that current replacement regimens fail to restore health-related subjective health status fully in patients with adrenal insufficiency (AI). Here we evaluated the subjective health status in primary and secondary AI and the effect of concomitant disease. In a cross-sectional study, all AI patients registered with the University Hospital Wuerzburg (n = 148) or with the German Self-Help Network (n = 200) were contacted by mail. Underlying diagnoses and comorbidities were verified by review of medical records. Patients were asked to complete three validated self-assessment questionnaires [Short Form 36 (SF-36), Giessen Complaint List (GBB-24), Hospital Anxiety and Depression Scale (HADS)]. Results were compared to sex- and age-matched controls drawn from the questionnaire-specific reference cohorts. We identified 348 patients, and 256 agreed to participate. Completed questionnaire sets were available from 210 patients [primary AI (n = 132), secondary AI (n = 78)]. Seven of eight SF-36 dimensions, all five GBB-24 scales, and the HADS anxiety score reflected significant impairment of subjective health status in both AI cohorts (all P < 0.001). Even after exclusion of all patients with any concomitant disease, subjective health status remained significantly impaired in five SF-36 subscales and four GBB-24 subscales. Secondary AI patients were slightly more compromised than primary AI, significant with regard to two SF-36 scales (P < 0.05) and the HADS depression score (P < 0.001). A total of 18.3% of the AI patients were out of work, compared to 4.1% in the general population. Patients with AI on current standard replacement suffer from significantly impaired health-related subjective health status, irrespective of origin of disease or concomitant disease. Future studies will have to assess whether more physiological glucocorticoid replacement strategies in AI will ameliorate these impairments.

0 comments Cited 71 times – based on 0 reviews      Review now

All references

Author and article information

Journal

Journal ID (nlm-ta): Endocr Connect

Journal ID (iso-abbrev): Endocr Connect

Journal ID (hwp): EC

Title: Endocrine Connections

Publisher: Bioscientifica Ltd (Bristol )

ISSN (Electronic): 2049-3614

Publication date Collection: January 2018

Publication date (Electronic): 12 December 2017

Volume: 7

Issue: 1

Pages: 211-219

Affiliations

[1]Department of Clinical and Experimental Medicine University of Catania, Catania, Italy

Author notes

Correspondence should be addressed to A E Calogero: acaloger@ 123456unict.it

Article

Publisher ID: EC170368

DOI: 10.1530/EC-17-0368

PMC ID: 5793805

PubMed ID: 29233815

SO-VID: d3f30892-2a12-4657-b3d1-33f33f4f6bff

License:

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The flagship journal of the Society for Endocrinology. Learn more

Dual-release hydrocortisone treatment: glycometabolic profile and health-related quality of life

Read this article at

Abstract

Objective

Design and Methods

Results

Conclusions

Related collections

Bioscientifica Open Endocrinology

Most cited references 16

Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies.

Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation.

Impaired subjective health status in 256 patients with adrenal insufficiency on standard therapy based on cross-sectional analysis.

Author and article information

Journal

Affiliations

Author notes

Article

History

Categories

Comments

Comment on this article

Similar content 212

Cited by 12

Most referenced authors 295