Consequences of suboptimal glucocorticoid replacement therapy in Addison’s disease; The metabolic syndrome and QoL.

Introduction:

Patients with Addison’s disease are treated with glucocorticoid replacement therapy (GRT). In spite of replacement therapy, patients with Addison’s disease experience a lot of complaints. Glucocorticoids are essential for life but in excess they produce many unwanted effects on metabolism, cardiovascular, musculoskeletal and immune function. Glucocorticoid side effects are probably dose dependent. The serious adverse effects of high dose GRT are reported in large trials in patients with different diseases including, asthma, SLE and rheumatoid arthritis. The evidence on which to support clear recommendations about toxicity of low dose glucocorticoids is weak. Patients with Addison’s disease are treated with long term low dose GRT. The effects of low dose GRT on quality of life and metabolism in this patient group are not clear.



Objective:

Assess the prevalence of the metabolic syndrome and quality of life in patients with Addison’s disease treated with low dose GRT.



Study design:

Case-control observational study.



Study population:

Patients with primary adrenal insufficiency on a stable replacement therapy with glucocorticoids will be included in this study and results will be compared to data of age and sex matched controls.



Endpoints:

Quality of life and prevalence of the metabolic syndrome.



Inconvenience, risks and advantages:

Blood samples will be obtained and participants have to complete questionnaires. There is a small risk of infection or haematoma formation when obtaining the blood sample. An advantage of participating in this study is treatment of risk factors if the metabolic syndrome is diagnosed.

1. Dutch patients with Addison's disease treated with suboptimal glucocorticoid replacement therapy have a reduced QoL;

2. Prevalence of the metabolic syndrome is higher among patients with Addison's disease treated with suboptimal glucocorticoid replacement therapy compared to healthy controls.

Cross sectional.

1. Questionnaires;

2. Measurement of blood pressure, weight, height, waist circumference;

3. A fasting blood sample.