Switching From Immediate-Release to Fractionated Dual-Release Hydrocortisone May Improve Metabolic Control and QoL in Selected Primary Adrenal Insufficiency Patients

Cese, Francesca Delle; Corsello, Andrea; Cintoni, Marco; Locantore, Pietro; Pontecorvi, Alfredo; Corsello, Salvatore Maria; Paragliola, Rosa Maria

doi:10.3389/fendo.2020.610904

Cited by 9 publications

(6 citation statements)

References 25 publications

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“…The meta-analysis by Bannon et al (11) which collected data from nine studies including two randomized controlled trials (12, 13) demonstrated how MRH, compared to standard therapies, has a positive effect on body mass index, lipid profile, glycemic control, especially in diabetic subjects, and improves QoL, causing side effects comparable to those of classical treatments. Similar results were reported in a very recent study by Delle Cese et al (14) that showed an improvement in metabolic control and QoL in a group of PAI switched from immediate-release hydrocortisone (IR-HC) to lower doses of MRH. However, only Guarnotta et al (15) achieved a follow-up of 48 months; the other existing trials have a shorter duration.…”

Section: Introductionsupporting

confidence: 89%

“…Similar results were reported in a very recent study by Delle Cese et al. ( 14 ) that showed an improvement in metabolic control and QoL in a group of PAI switched from immediate-release hydrocortisone (IR-HC) to lower doses of MRH. However, only Guarnotta et al.…”

Section: Introductionsupporting

confidence: 89%

“…However, as stated before, this is the first study reporting SC levels in patients taking exclusively CA as classic replacement therapy. All previous studies have considered patients treated only with IR-HC or subgroups of patients treated with either IR-HC or with CA (3,(11)(12)(13)(14)(15)(16). In a study by Feek et al (25), comparing patients treated with IR-HC 20 mg to the ones on a corresponding replacement dose of CA (25 mg), IR-HC was associated with higher mean cortisol and lower mean ACTH levels.…”

Section: Discussionmentioning

confidence: 99%

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Effects of the therapy shift from cortisone acetate to modified-release hydrocortisone in a group of patients with adrenal insufficiency

et al. 2023

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ObjectivePatients with adrenal insufficiency (AI) may be exposed to supraphysiological glucocorticoids levels during standard treatment with cortisone acetate (CA) or immediate-release hydrocortisone (IR-HC). Recent studies, predominantly including patients in IR-HC treatment, suggested that modified-release hydrocortisone (MRH) provide a more physiological cortisol rhythm, improving metabolic control and quality of life. Our primary aim was to assess clinical and biochemical modifications in patients shifted from CA to MRH.Design/MethodsWe designed a retrospective longitudinal study, enrolling 45 AI patients (22 primary and 23 secondary AI) treated exclusively with CA thrice daily, shifted to MRH once daily; 29/45 patients concluded at least 18-months follow-up (MRH-group). We recruited 35 AI patients continuing CA as a control group (CA-group). Biochemical and clinical data, including metabolic parameters, bone quality, and symptoms of under- or overtreatment were collected. In 24 patients, a daily salivary cortisol curve (SCC) performed before and one month after shifting to MRH was compared to healthy subjects (HS).ResultsNo significant changes in glycometabolic and bone parameters were observed both in MRH and CA-groups during a median follow-up of 35 months. A more frequent decrease in blood pressure values (23.1% vs 2.8%, p=0.04) and improvement of under- or overtreatment symptoms were observed in MRH vs CA-group. The SCC showed a significant steroid overexposure in both CA and MRH-groups compared to HS [AUC (area under the curve) = 74.4 ± 38.1 nmol×hr/L and 94.6 ± 62.5 nmol×hr/L respectively, vs 44.1 ± 8.4 nmol×hr/L, p<0.01 for both comparisons], although SCC profile was more similar to HS in MRH-group.ConclusionsIn our experience, patients shifted from CA to equivalent doses of MRH do not show significant glycometabolic modifications but blood pressure control and symptoms of over-or undertreatment may improve. The lack of amelioration in glucose metabolism and total cortisol daily exposure could suggest the need for a dose reduction when shifting from CA to MRH, due to their different pharmacokinetics.

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Section: Introductionsupporting

confidence: 89%

Section: Introductionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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Effects of the therapy shift from cortisone acetate to modified-release hydrocortisone in a group of patients with adrenal insufficiency

et al. 2023

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“…The modified-release preparation has a dual-release mechanism; an outer coating for an immediate release of hydrocortisone, and an inner core for a more sustained slower release. Studies have reported a significant reduction in body mass index, improved lipid profile, better glycaemic control and improved quality of life in those who are in the MR-HC group ( 58 , 59 ). In a recent clinical trial comparing immediate-release and MR-HC in patients with CAH, both groups were able to achieve better 24-hour 17-OHP levels at 24 weeks compared to baseline, thus failing to prove their primary outcome.…”

Section: Hypoglycaemia In Adrenal Insufficiencymentioning

confidence: 99%

Hypoglycaemia in adrenal insufficiency

Lee,

Baranowski,

Sakremath

et al. 2023

Front. Endocrinol.

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Adrenal insufficiency encompasses a group of congenital and acquired disorders that lead to inadequate steroid production by the adrenal glands, mainly glucocorticoids, mineralocorticoids and androgens. These may be associated with other hormone deficiencies. Adrenal insufficiency may be primary, affecting the adrenal gland’s ability to produce cortisol directly; secondary, affecting the pituitary gland’s ability to produce adrenocorticotrophic hormone (ACTH); or tertiary, affecting corticotrophin-releasing hormone (CRH) production at the level of the hypothalamus. Congenital causes of adrenal insufficiency include the subtypes of Congenital Adrenal Hyperplasia, Adrenal Hypoplasia, genetic causes of Isolated ACTH deficiency or Combined Pituitary Hormone Deficiencies, usually caused by mutations in essential transcription factors. The most commonly inherited primary cause of adrenal insufficiency is Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency; with the classical form affecting 1 in 10,000 to 15,000 cases per year. Acquired causes of adrenal insufficiency can be subtyped into autoimmune (Addison’s Disease), traumatic (including haemorrhage or infarction), infective (e.g. Tuberculosis), infiltrative (e.g. neuroblastoma) and iatrogenic. Iatrogenic acquired causes include the use of prolonged exogenous steroids and post-surgical causes, such as the excision of a hypothalamic-pituitary tumour or adrenalectomy. Clinical features of adrenal insufficiency vary with age and with aetiology. They are often non-specific and may sometimes become apparent only in times of illness. Features range from those related to hypoglycaemia such as drowsiness, collapse, jitteriness, hypothermia and seizures. Features may also include signs of hypotension such as significant electrolyte imbalances and shock. Recognition of hypoglycaemia as a symptom of adrenal insufficiency is important to prevent treatable causes of sudden deaths. Cortisol has a key role in glucose homeostasis, particularly in the counter-regulatory mechanisms to prevent hypoglycaemia in times of biological stress. Affected neonates particularly appear susceptible to the compromise of these counter-regulatory mechanisms but it is recognised that affected older children and adults remain at risk of hypoglycaemia. In this review, we summarise the pathogenesis of hypoglycaemia in the context of adrenal insufficiency. We further explore the clinical features of hypoglycaemia based on different age groups and the burden of the disease, focusing on hypoglycaemic-related events in the various aetiologies of adrenal insufficiency. Finally, we sum up strategies from published literature for improved recognition and early prevention of hypoglycaemia in adrenal insufficiency, such as the use of continuous glucose monitoring or modifying glucocorticoid replacement.

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“…However, data on its use in CAH patients are lacking. Recent small nonrandomized studies in adults with primary adrenal insufficiency suggest a small benefit in fatigueability [13 ▪ ], and benefits in sleep quality [14 ▪ ], blood pressure, BMI, ACTH, HbA1c, cholesterol, and quality of life [15 ▪ ,16 ▪ ].…”

Section: Alternative Hydrocortisone Preparationsmentioning

confidence: 99%

Emerging treatment for congenital adrenal hyperplasia

White

2022

Current Opinion in Endocrinology, Diabetes &Amp; Obesity

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Purpose of reviewAlthough the basic treatment of congenital adrenal hyperplasia (CAH) is well established, there are active clinical research projects to more closely mimic the normal diurnal rhythm of cortisol secretion and to reduce total glucocorticoid doses to minimize adverse metabolic effects. Recent findingsWe review clinical studies on CAH treatment published in the last 18 months or currently underway according to ClinicalTrials.gov listings. These can be grouped into several broad themes: alternative dosing forms of hydrocortisone with altered pharmacokinetics or easier dose titration; corticotropin-releasing hormone receptor antagonists that reduce corticotropin (ACTH) secretion and thereby reduce adrenal androgen secretion; androgen biosynthesis inhibitors; a first clinical trial of a gene therapy vector.

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Switching From Immediate-Release to Fractionated Dual-Release Hydrocortisone May Improve Metabolic Control and QoL in Selected Primary Adrenal Insufficiency Patients

Cited by 9 publications

References 25 publications

Effects of the therapy shift from cortisone acetate to modified-release hydrocortisone in a group of patients with adrenal insufficiency

Effects of the therapy shift from cortisone acetate to modified-release hydrocortisone in a group of patients with adrenal insufficiency

Hypoglycaemia in adrenal insufficiency

Emerging treatment for congenital adrenal hyperplasia

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