In treatment-naive adrenal insufficiency, 10 years of conventional glucocorticoid treatment is associated with worsening of metabolic, insulin-sensitivity, cardiac, and bone outcomes, while dual-release hydrocortisone had no impact on them, achieving a lower risk of developing comorbidities.
Key Findings
Results
Patients treated with conventional glucocorticoids had significantly higher BMI and waist circumference at 10 years compared to those treated with DR-HC.
42 patients were randomized to conventional GCs (cortisone acetate or hydrocortisone) and 44 to DR-HC in a 1:1 prospective randomization.
BMI difference was statistically significant at P = .031.
Waist circumference difference was statistically significant at P = .047.
Assessments were conducted at baseline, 5 years, and 10 years of follow-up.
Results
Conventional glucocorticoid treatment was associated with significantly worse cardiovascular parameters at 10 years compared to DR-HC.
Systolic blood pressure was significantly higher in the conventional GC group (P = .039).
Total cholesterol was significantly higher in the conventional GC group (P = .041).
LDL cholesterol was significantly higher in the conventional GC group (P = .042).
Thickness of the interventricular septum in diastole and of the posterior wall were both significantly higher in the conventional GC group (both P < .001).
Results
Conventional glucocorticoid treatment was associated with significantly worse glycemic and insulin sensitivity outcomes at 10 years compared to DR-HC.
HbA1c was significantly higher in the conventional GC group (P = .040).
HOMA-IR was significantly higher in the conventional GC group (P = .006).
AUC2h of glucose was significantly higher in the conventional GC group (P < .001).
Oral disposition index was significantly lower in the conventional GC group (P = .001).
ISI-Matsuda was significantly lower in the conventional GC group (P < .001).
Results
Conventional glucocorticoid treatment was associated with significantly worse bone parameters at 10 years compared to DR-HC.
Lumbar spine T score was significantly lower in the conventional GC group (P = .036).
Femoral neck Z score was significantly lower in the conventional GC group (P = .026).
The study enrolled treatment-naive patients with adrenal insufficiency, allowing assessment of treatment effects from the start of therapy.
Methods
The study was a prospective randomized trial registered at ClinicalTrials.gov evaluating 10-year outcomes in treatment-naive adrenal insufficiency patients.
86 total patients were enrolled: 42 randomized to conventional GCs and 44 to DR-HC.
Primary outcome was the impact of 10 years of conventional GCs versus DR-HC on body weight changes.
Secondary outcomes included changes in anthropometric and metabolic profile, insulin sensitivity, cardiovascular, and bone parameters from baseline to 5 and 10 years.
Background
Adrenal insufficiency is characterized by increased mortality compared to the general population, primarily due to cardiovascular disease, with conventional glucocorticoid replacement therapy contributing to this increased mortality risk.
Conventional glucocorticoid replacement therapy was identified as having a role in determining the increased mortality risk in adrenal insufficiency.
Cardiovascular disease was cited as the main driver of the increased mortality in adrenal insufficiency.
This background context motivated the comparison of conventional GCs versus dual-release hydrocortisone over 10 years.
Guarnotta V, Di Stefano C, Tomasello L, Maniscalco L, Pizzolanti G, Arnaldi G, et al.. (2024). Conventional steroids vs. dual-release hydrocortisone on metabolic, cardiovascular, and bone outcomes in adrenal insufficiency: a 10-year study.. European journal of endocrinology. https://doi.org/10.1093/ejendo/lvae107