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

Abstract

Objective: The 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.

Methods: Twenty 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.

Results: Our 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.

Conclusion: The 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.

Keywords: adrenocorticotropic hormone; dual-release hydrocortisone; immediate-release hydrocortisone; modified-release hydrocortisone; primary adrenal insufficiency.

Figure 1

The figure reports the study design. The study is a prospective, two-armed, interventional study with a 6 months observational period. Biochemical and metabolic parameters and AddiQoL-30 test have been collected at baseline and six months after the switch to DR-HC in group A and group B. ACTH, adrenocorticotropic hormone; BID, divided in two doses; BMI, body mass index; DR-HC, dual-release hydrocortisone; HbA1c, glycated hemoglobin; IR-HC, immediate-release hydrocortisone; QoL, quality of life; TID, divided in three doses.