Search Results

Objective

Evaluation of the pharmacokinetics and safety of s.c. hydrocortisone injection for use in adrenal emergency.

Design

Single-center, open-label, sequence-randomized, crossover study in a tertiary care center.

Patients and methods

Twelve patients with chronic Addison's disease. Comparison of hydrocortisone pharmacokinetics after s.c. and i.m. injection (100 mg) and after s.c. administration of sodium chloride (0.9%) respectively at three different visits.

Main outcome measure: maximum serum cortisol (C _max), time to C _max (t _max), and time to serum cortisol >36 μg/dl (t _{serum cortisol >36 μg/dl}) after s.c. administration compared with i.m. administration, safety, and patient preference.

Results

Serum cortisol increased rapidly and substantially after both i.m. and s.c. injections (C _max: 110±29 vs 97±28 μg/dl, P=0.27, t _max: 66±51 vs 91±34 min, P=0.17, and t _{serum cortisol >36 μg/dl}: 11±5 vs 22±11 min, P=0.004 respectively). Both i.m. and s.c. injections were well tolerated. Eleven (91.7%) patients preferred s.c. injection, whereas one patient did not have any preference.

Conclusions

S.c. administration of 100 mg hydrocortisone shows excellent pharmacokinetics for emergency use with only a short delay in cortisol increase compared with i.m. injection. It has a good safety profile and is preferred by patients over i.m. injection.

Objective

Replacement therapy in primary adrenal insufficiency (PAI) with corticosteroids modulates sodium homeostasis. Serum sodium is, however, prone to osmotic shifts induced by several additional factors besides corticosteroids and does not always reliably reflect treatment quality. Non-osmotic tissue storage can be visualized by sodium MRI (²³Na-MRI) and might better reflect corticosteroid activity.

Design

Longitudinal study of 8 patients with newly diagnosed PAI and cross-sectional study in 22 patients with chronic PAI is reported here. Comparison was made with matched healthy controls.

Methods

Using a ²³Na-MRI protocol on a 3T scanner, relative sodium signal intensities (rSSI) to signal intensities of the reference vial with 100 mmol/L of sodium were determined in the muscle and skin of the lower calf.

Results

In newly diagnosed patients, tissue rSSI (median, range) were reduced and significantly increased after treatment initiation reaching levels similar to healthy controls (muscle: from 0.15 (0.08, 0.18) to 0.18 (0.14, 0.27), P = 0.02; skin: from 0.12 (0.09, 0.18) to 0.18 (0.14, 0.28), P < 0.01). Muscle rSSI was significantly higher in patients with chronic PAI compared to controls (0.19 (0.14, 0.27) vs 0.16 (0.12, 0.20), P < 0.01). In chronic PAI, skin rSSI significantly correlated with plasma renin concentration.

Conclusion

²³Na-MRI provides an additional insight into sodium homeostasis, and thus the quality of replacement therapy in PAI, as tissue sodium significantly changes once therapy is initiated. The increased tissue sodium in patients with chronic PAI might be an indication of over-replacement.

Objective

Patients with adrenal insufficiency (AI) suffer from impaired quality of life and are at risk of adrenal crisis (AC) despite established replacement therapy. Patient education is regarded an important measure for prevention of AC and improvement of AI management. A standardized education programme was elaborated for patients with chronic AI in Germany.

Design

Longitudinal, prospective, questionnaire-based, multi-centre study.

Methods

During 2-h sessions, patients (n = 526) were provided with basic knowledge on AI, equipped with emergency cards and sets and trained in self-injection of hydrocortisone. To evaluate the education programme, patients from eight certified centres completed questionnaires before, immediately after and 6–9 months after training.

Results

399 completed data sets were available for analysis. Questionnaire score-values were significantly higher after patient education, indicating successful knowledge transfer (baseline: 17 ± 7.1 of a maximum score of 29; after training: 23 ± 4.2; P < 0.001), and remained stable over 6–9 months. Female sex, younger age and primary cause of AI were associated with higher baseline scores; after education, age, cause of AI and previous adrenal crisis had a significant main effect on scores. 91% of patients would dare performing self-injection after training, compared to 68% at baseline. An improvement of subjective well-being through participation in the education programme was indicated by 95% of the patients 6–9 months after participation.

Conclusion

Patient group education in chronic AI represents a helpful tool for the guidance of patients, their self-assurance and their knowledge on prevention of adrenal crises. Repeated training and adaptation to specific needs, for example, of older patients is needed.