Marcus Quinkler1, Roy Miodini Nilsen2, Kathrin Zopf2, Manfred Ventz2, Marianne Øksnes3. 1. 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. 2. 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. 3. 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.
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. DESIGN AND 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.
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. DESIGN AND 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 hyperplasiapatients 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: A M Isidori; G Arnaldi; M Boscaro; A Falorni; C Giordano; R Giordano; R Pivonello; C Pozza; E Sbardella; C Simeoli; C Scaroni; A Lenzi Journal: J Endocrinol Invest Date: 2019-11-26 Impact factor: 4.256