Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Section of Endocrinology, University of Palermo, Piazza delle Cliniche 2, 90127 Palermo, Italy.
Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Via del Vespro 133, 90127 Palermo, Italy.
Eur J Endocrinol. 2024 Aug 30;191(3):300-311. doi: 10.1093/ejendo/lvae107.
Adrenal insufficiency (AI) is characterized by increased mortality compared to general population, mainly due to cardiovascular disease. Conventional glucocorticoid (GC) replacement therapy has a role in determining the increased mortality risk. Primary outcome of the current study was to evaluate the impact of 10 years of conventional GCs and DR-HC on body weight changes in treatment-naive patients with AI. Secondary outcomes were changes from baseline to 5 and 10 years in anthropometric and metabolic profile, insulin sensitivity, cardiovascular, and bone parameters.
We prospectively randomized 42 patients to conventional GCs (cortisone acetate or hydrocortisone) and 44 to DR-HC (1:1). Anthropometric, metabolic, cardiovascular, and bone parameters were evaluated at baseline and after 5 and 10 years of follow-up. This trial is registered at ClinicalTrials.gov NCT06260462.
At 10 years of follow-up, patients with conventional GCs had significantly higher values of BMI (P = .031), waist circumference (P = .047), systolic blood pressure (P = .039), total and LDL cholesterol (P = .041 and P = .042), HbA1c (P = .040), HOMA-IR (P = .006), AUC2h of glucose (P < .001), thickness of the interventricular septum in diastole and of the posterior wall (both P < .001) and significantly lower values of oral disposition index (P = .001) and ISI-Matsuda (P < .001), lumbar spine T score (P = .036), and femoral neck Z score (P = .026), compared to patients treated with DR-HC.
In patients with treatment-naive AI, 10 years of conventional GC treatment is associated with a worsening of metabolic, insulin-sensitivity, cardiac, and bone outcomes, while DR-HC had no impact on them achieving a lower risk of developing comorbidities.
与普通人群相比，肾上腺功能不全（AI）的特征是死亡率增加，主要归因于心血管疾病。常规糖皮质激素（GC）替代疗法在确定增加的死亡率风险方面具有作用。本研究的主要结局是评估 10 年常规 GCs 和 DR-HC 对 AI 初治患者体重变化的影响。次要结局是从基线到 5 年和 10 年时的人体测量和代谢特征、胰岛素敏感性、心血管和骨骼参数的变化。
我们前瞻性地将 42 例患者随机分为常规 GCs（醋酸可的松或氢化可的松）组和 DR-HC（1:1）组。在基线时和随访 5 年和 10 年后评估人体测量、代谢、心血管和骨骼参数。该试验在 ClinicalTrials.gov 注册，编号为 NCT06260462。
在 10 年的随访中，接受常规 GCs 治疗的患者 BMI（P =.031）、腰围（P =.047）、收缩压（P =.039）、总胆固醇和 LDL 胆固醇（P =.041 和 P =.042）、HbA1c（P =.040）、HOMA-IR（P =.006）、AUC2h 葡萄糖（P <.001）、舒张期室间隔和后壁厚度（均 P <.001）显著增加，而口服葡萄糖处置指数（P =.001）和 ISI-Matsuda（P <.001）、腰椎 T 评分（P =.036）和股骨颈 Z 评分（P =.026）显著降低，与接受 DR-HC 治疗的患者相比。
在 AI 初治患者中，10 年常规 GC 治疗与代谢、胰岛素敏感性、心脏和骨骼结局恶化相关，而 DR-HC 对这些结局没有影响，降低了发生合并症的风险。
