Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments

Research output: Contribution to journalJournal articleResearchpeer-review

  1. CPMS-improving patient care in Europe via virtual case discussions

    Research output: Contribution to journalReviewpeer-review

  2. ENDO-ERN expert opinion on the differential diagnosis of pubertal delay

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Serum insulin-like factor 3 quantification by LC-MS/MS in male patients with hypogonadotropic hypogonadism and Klinefelter syndrome

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Physiological factors contributing to HbA1c in the normal and pre-diabetic range: a cross-sectional analysis

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. The association of thyroid stimulation hormone levels with incident ischemic heart disease, incident stroke, and all-cause mortality

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Sex differences in acromegaly at diagnosis: A nationwide cohort study and meta-analysis of the literature

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Adrenal insufficiency in kidney transplant patients during low-dose prednisolone therapy: a cross-sectional case-control study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Limited diagnostic utility of Chromogranin A measurements in workup of neuroendocrine tumors

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Corticotroph aggressive pituitary tumours and carcinomas frequently harbour ATRX mutations

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

PURPOSE: Replicating the physiological cortisol secretion is key in the treatment of glucocorticoid insufficient individuals and optimization may enhance quality of life. The study investigates fatigue measured by ecological momentary assessments in patients treated with conventional hydrocortisone compared with once-daily dual-release hydrocortisone (Plenadren).

METHODS: A 21-week open-label switch pilot trial included 30 patients with adrenal insufficiency due to hypopituitarism. Fatigue was assessed four times daily for 20 days using a momentary item version of the Multidimensional Fatigue Inventory on patients' usual hydrocortisone regimen. Participants switched treatment to an identical daily dose of Plenadren for 16 weeks where fatigue assessments were repeated. Change in fatigue and diurnal variation of fatigue was analyzed using mixed models for repeated measurements.

RESULTS: In four out of five fatigue subscales fatigue was significantly reduced 0.7-1.1 points (scales ranging from 4 to 20), when treated with Plenadren compared with conventional hydrocortisone, corresponding to small effect sizes below the scale-specific minimal important changes. However, 33% of the participants completing the study (9/27) experienced reductions in fatigue above the minimal important change. On Plenadren, we found larger between-person variances and smaller within-person variances. Finally, we identified diurnal fatigue curves for both treatments.

CONCLUSIONS: The Plenadren-related reduction in fatigue was significant but not necessarily of clinical importance when looking at a group level. However, there was a large interindividual variation in treatment effect, why patients with a large benefit in quality of life should be identified. Future RCTs should be powered to detect the effect magnitudes identified here.

Original languageEnglish
JournalEndocrine
Volume71
Issue number2
Pages (from-to)467-475
ISSN1355-008X
DOIs
Publication statusPublished - Feb 2021

ID: 61433137