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

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

doi:10.3389/fendo.2020.610904

Abstract

ObjectiveThe use of once-daily dual-release HC (DR-HC) in primary adrenal insufficiency (PAI) is often associated with benefits in metabolic parameters when compared to immediate-release HC (IR-HC). In this study, we evaluated the effects on clinical, biochemical and metabolic parameters of switching from IR-HC to lower-dose DR-HC given both in once and fractionated daily doses.MethodsTwenty autoimmune-PAI subjects were included. Patients on 30 mg/day divided in three doses IR-HC regimen (group A) were switched to DR-HC 25 mg/day given in two daily doses (20 mg in the morning and 5 mg at 2.00 p.m.); patients on 25 mg/day divided in two doses IR-HC regimen (group B) were switched to DR-HC 20 mg once daily. Biochemical and metabolic parameters, BMI and quality of life (QoL) were evaluated at the baseline and six months after the switch.ResultsOur small non-randomized study with short follow up showed significant benefits in both group A and group B without any apparent side-effects. After the switch to DR-HC, a significant decrease in adrenocorticotropic hormone (ACTH), HbA1c, total cholesterol, triglycerides, LDL, cholesterol, BMI as well as a significant improvement in QoL, were observed in both groups. At 6 months, ACTH levels were lower in group A while HbA1C and total cholesterol were lower in group B.ConclusionThe DR-HC is a valid and effective therapeutic strategy to improve the metabolic control and the QoL in PAI. The reduction of ACTH levels with DR-HC regimens reflects a better biochemical control of PAI, obtained by using a lower dose and more physiological HC formulation. Both once-daily and fractionated daily doses of DR-HC showed advantages compared with IR-HC formulation.

Highlights

Primary adrenal insufficiency (PAI) represents a rare but potentially life-threatening disorder due to chronic glucocorticoid and mineralocorticoid deficiency
The results showed that both once-daily and fractionated daily doses of dual-release hydrocortisone (DR-HC) present advantages in terms of metabolic profile and adrenocorticotropic hormone (ACTH) levels compared with immediate-release HC (IR-HC) formulation
DR-HC fractionated dose (20 mg at waking time and 5 mg at 2.00 p.m) can be useful in patients who are not well replaced by using a single daily dose and who complain about symptoms of hypoadrenalism in the second half of the day instead of increasing DR-HC posology or switching to immediate-release coating (IR)-HC

Summary

Introduction

Primary adrenal insufficiency (PAI) represents a rare but potentially life-threatening disorder due to chronic glucocorticoid and mineralocorticoid deficiency. Since cortisol and aldosterone are essential regulators of water and electrolyte homeostasis, PAI requires a prompt and adequate replacement therapy to avoid severe complications. Despite optimal conventional replacement therapy, patients affected by PAI suffer from poor quality of life (QoL), comorbidities and increased mortality [2, 3]. These poor outcomes are partially related to the risk of adrenal crisis, which represents the most severe complication in PAI, and even more to the increased risk of infections and metabolic diseases associated with higher daily glucocorticoid replacement doses [4]

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