The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments
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The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments. / Boesen, Victor Brun; Borresen, Stina Willemoes; Christoffersen, Thea; Klose, Marianne; Watt, Torquil; Feldt-Rasmussen, Ulla.
I: Endocrine, Bind 71, 2021, s. 467–475.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - The effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments
AU - Boesen, Victor Brun
AU - Borresen, Stina Willemoes
AU - Christoffersen, Thea
AU - Klose, Marianne
AU - Watt, Torquil
AU - Feldt-Rasmussen, Ulla
PY - 2021
Y1 - 2021
N2 - PurposeReplicating 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).MethodsA 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.ResultsIn 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.ConclusionsThe 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.
AB - PurposeReplicating 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).MethodsA 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.ResultsIn 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.ConclusionsThe 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.
KW - Glucocorticoid insufficiency
KW - Pituitary insufficiency
KW - Fatigue
KW - Ecological momentary assessments
KW - Dual-release hydrocortisone
U2 - 10.1007/s12020-020-02507-x
DO - 10.1007/s12020-020-02507-x
M3 - Journal article
C2 - 33063273
VL - 71
SP - 467
EP - 475
JO - Endocrine
JF - Endocrine
SN - 1355-008X
ER -
ID: 250553958