title: Modified-release hydrocortisone decreases BMI and HbA1c in patients with primary and secondary adrenal insufficiency.
abstract: OBJECTIVE
  Patients with adrenal insufficiency (AI) have impaired health-related quality of life (HRQoL), which is thought to be in part due to unphysiological glucocorticoid replacement therapy. The aim was to compare once-daily hydrocortisone (HC) dual-release tablet (modified-release) with conventional HC therapy regarding clinical data and HRQoL.
  
  
  METHODS
  We conducted an open, prospective trial at one endocrine center. There were 15 of 26 patients with primary AI, nine of 18 patients with secondary AI, and six congenital adrenal hyperplasia patients switched to modified-release HC therapy by their own decision. We evaluated clinical outcome and disease-specific HRQoL by using AddiQoL questionnaire at baseline and at follow-up (median 202 days (85-498)).
  
  
  RESULTS
  Patients on modified-release HC (n=30) showed significant decreases in BMI (26.0±0.75-25.6±0.71, P for change=0.006) and HbA1c (6.04±0.29-5.86±0.28, P for change=0.005), whereas patients remaining on conventional HC (n=20) showed no change in these parameters (P for interaction=0.029 and 0.017 respectively). No significant change in AddiQoL score were found in the modified-release HC group (83.8 baseline and 84.9 at follow-up; P for change=0.629). In the conventional HC group, there was a significant decrease in scores (84.0 baseline and 80.9 at follow-up; P for change=0.016), with a between-treatment P for interaction of 0.066. The fatigue subscore of AddiQoL showed the same pattern with a significant decrease (P for change=0.024) in patients on conventional HC therapy (P for interaction=0.116).
  
  
  CONCLUSIONS
  Modified-release HC decreases BMI and HbA1c compared with conventional HC treatment. In addition, it seems to stabilize HRQoL over time.
authors: Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway marcusquinkler@t-online.de.
authors: Marcus
authors: M
authors: Quinkler
authors: Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway.
authors: Roy
authors: R
authors: Miodini Nilsen
authors: Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway.
authors: Kathrin
authors: K
authors: Zopf
authors: Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway.
authors: Manfred
authors: M
authors: Ventz
authors: Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway Endocrinology in CharlottenburgStuttgarter Platz 1, 10627 Berlin, GermanyClinical EndocrinologyCharité Campus Mitte, Charité University Medicine Berlin, Berlin, GermanyCentre for Clinical ResearchHaukeland University Hospital, Bergen, NorwayDepartment of Clinical ScienceUniversity of Bergen, Bergen, NorwayDepartment of MedicineHaukeland University Hospital, Bergen, Norway.
authors: Marianne
authors: M
authors: Øksnes
mesh_terms: D000312:Adrenal Hyperplasia, Congenital / Q000188:drug therapy / Q000523:psychology; D000309:Adrenal Insufficiency / Q000188:drug therapy* / Q000378:metabolism / Q000523:psychology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015992:Body Mass Index; D003692:Delayed-Action Preparations; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D006442:Glycated Hemoglobin; D006854:Hydrocortisone; D008055:Lipids