Continuous Hydrocortisone Infusion Bests Oral Therapy for Quality of Life in Addison’s Disease: Presented at ENDO

By Fred Gebhart

SAN FRANCISCO -- June 19, 2013 -- Continuous subcutaneous hydrocortisone infusion improves quality of life (QOL) in patients with Addison’s disease, according to a study presented here at the 95th Annual Meeting of the Endocrine Society (ENDO).

Oral glucocorticoid replacement therapy is the standard treatment for Addison’s disease, but clinicians have long recognised that oral therapy does not adequately restore QOL.

The problem is that twice-daily oral dosing does not do a good job of mimicking the natural circadian rhythm of adrenal hormones, explained Marianne Oksnes, MD, University of Bergen, Bergen, Norway, on June 16.

One element of the EurAdrenal trial was to compare QOL outcomes with conventional oral dosing versus continuous subcutaneous dosing. The data strongly favour continuous infusion.

“We used standard insulin pumps to deliver subcutaneous doses of glucocorticoids,” said Dr. Oksnes. “Insulin pumps are an affordable, off-the-shelf, easy-to-use technology for this novel delivery method of the conventional drug treatment for Addison’s.”

Researchers conducted a prospective, randomised crossover study at multiple centres that compared 3 months of oral hydrocortisone with 3 months of continuously infused subcutaneous hydrocortisone. Patients were evaluated at baseline and at 2 and 3 months on each of the treatments. QOL was evaluated with the Addiqol instrument, as well as more generic instruments, ie, the SF-36 and the PGWBI (Psychological General Well-Being Index).

The study included 33 patients (8 men). Their mean age was 48 years and mean duration of Addison’s disease was 12.4 years. There were no between-group differences in weight, waist or hip circumference, or diastolic or systolic blood pressure.

The median pretrial hydrocortisone equivalent dose was 0.36 mg/kg daily. Oral doses of hydrocortisone during the trial were slightly lower than the infused doses, at 0.23 versus 0.28 mg/kg daily.

Addiqol scores increased significantly during continuous infusion (P for trend < .001) compared with baseline but did not change during oral dosing (P for trend = .90). The difference indicates that continuous subcutaneous infusion improves QOL versus oral dosing (P for interaction = .01).

PGWBI total score also improved during continuous subcutaneous infusion, but not statistically significantly compared with oral dosing. However, the PGWBI vitality and anxiety subscales showed significant improvement during subcutaneous infusion compared with oral dosing (P for interaction = .029 and .04, respectively).

For SF-36, changes in QOL only appeared on the physical function subscale, with continuous infusion showing improvement (P for trend = .076) and oral dosing scores remaining unchanged (P for trend = .299), with continuous infusion producing overall higher QOL scores (P for interaction = .027).

Funding for the study was provided by EurAdrenal.

[Presentation title: Continuous Subcutaneous Hydrocortisone Infusion (CSHI) Improves Quality-of-Life in Addison’s Disease (AD). Abstract FP21-4]

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