ICEECE2012 Poster Presentations Adrenal cortex (113 abstracts)
An open, multi-centre, phase IIIB, long term follow-up study to assess the safety, tolerability and efficacy of once-daily oral dual-release hydrocortisone in patients with adrenal insufficiency
G. Johannsson 1 , A. Nilsson 1 , R. Bergthorsdottir 1 , P. Burman 2 , P. Dahlqvist 3 , B. Ekman 4 , B. Edén Engström 5 , O. Ragnarsson 1 , M. Ryberg 3 , J. Wahlberg 4 & S. Skrtic 1
1Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 2University Hospital MAS, Malmö, Sweden; 3Umeå University, Umeå, Sweden; 4Linköping University, Linköpin, Sweden; 5Uppsala University Hospital, Uppsala University, Uppsala, Sweden.
Introduction: There are limited prospective safety data on glucocorticoid replacement. The aim of this study was to assess the safety and efficacy during long term treatment using a once-daily oral dual-release hydrocortisone in patients with adrenal insufficiency (AI).
Methods: This is an open, multi-centre study in 71 patients with AI. Most patients were recruited from a previous controlled trial (n=53) where they had received the dual-release therapy 6–9 months [1] before entering this trial. Every 6 months, clinical and laboratory assessments were performed.
Results: After 18 months 94.6% of patients remained in the study. The median dose was 30 mg (range 20–40 mg) at entry. Nine patients reduced and 6 patients increased their dose during the 18 months. Total serum cholesterol (0.2 mmol/l; P=0.03), LDL-cholesterol (0.2 mmol/l; P=0.03) and HDL-cholesterol concentrations increased (0.2 mmol/l; P<0.0001) while triglycerides decreased (−0.4 mmol/l; P<0.0001). In 13 patients with DM HDL-cholesterol increased (0.3 mmol/l; P=0.004) triglycerides decreased (−0.2 mmol/l; P=0.03) and HbA1c was unchanged.
Systolic blood pressure (−0.4 mm Hg), diastolic blood pressure (0.7 mm Hg) and body weight (−0.8 kg) did not change significantly.
The average number of AEs per patient was 4.5 from 0 to 18 months. Most AEs were classified as “infections and infestations” (40%). The most commonly reported events were nasopharyngitis (20%), fatigue (7%) and gastroenteritis (6%), which is similar to conventional hydrocortisone replacement [1]. The frequency of AEs were similar in the beginning and at the end of the study.
There were 13 non-fatal serious AEs reported; 2 Addison crisis, 6 gastroenteritis, 1 case each of pyelonephritis, gastritis/esophagitis, virosis, colitis and ectopic pregnancy.
Conclusions: No safety concerns were observed in this open prospective study using a new oral dual-release hydrocortisone replacement therapy. Some continuing beneficial metabolic effects could be seen in particular in patients with concomitant DM.
1. Johannsson, G., et al., J Clin Endocrinol Metab, 2011 Nov 23.
Declaration of interest: I fully declare a conflict of interest. Details below.
Funding: This work was supported, however funding details unavailable.
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Endocrine Abstracts
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