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• W4280490525 abstract "CD is a deleterious hypercortisolism disorder. Alleviating the burden of CD-associated comorbidities, including HTN and DM, is a key treatment goal. Osilodrostat, a potent oral 11β-hydroxylase inhibitor, normalized urinary free cortisol (UFC) and improved clinical signs and symptoms in CD patients (pts) in the Phase III LINC 3 study (NCT02180217). We describe blood pressure (BP) and glucose homeostasis changes in pts with baseline (BL) HTN and DM. Adults with CD and mean UFC >1.5 times the upper limit of normal received osilodrostat during the 48-week (W) core study, including an 8W randomized-withdrawal phase (W26–34) for eligible pts (Pivonello et al. Lancet Diabetes Endocrinol 2020). BL HTN defined as prior diagnosis, taking antihypertensive medication, and/or systolic/diastolic blood pressure (SBP/DBP) >130/ >90 mmHg. BL DM defined as prior diagnosis, taking antidiabetic medication, HbA1c ≥6.5%, and/or fasting plasma glucose (FPG) ≥126 mg/dL. Exploratory data presented for all pts with data at BL and given visit, unless otherwise stated. At BL, 87% (119/137) of pts were classed as hypertensive; mean SBP and DBP decreased in these pts during osilodrostat therapy. Of pts with BL SBP >130 mmHg (n=79), 58%, 51% and 49% had SBP ≤130 mmHg at W12, W24 and W48. Of pts with BL DBP >90 mmHg (n=50), 72%, 62% and 66% had DBP ≤90 mmHg at W12, W24 and W48. SBP/DBP remained stable in pts without BL HTN. Higher BL SBP and DBP correlated with greater reductions in these parameters at W24 (SBP, r=−0.57; DBP, r=−0.57 [both P< 0.0001]) and W48 (SBP, r=−0.58; DBP, r=−0.57 [both P< 0.0001]). 40% (34/85) of pts taking antihypertensive medication at BL stopped or reduced the dose by W48; 40% (34/85) increased dose or number of medications. Mean 11-deoxycorticosterone (DOC) increased during the study. Mean potassium levels remained largely unchanged and did not correlate with DOC increases. 45% (61/137) of pts were classed as diabetic at BL. Of pts with BL FPG ≥100 mg/dL (n=36), 58%, 64% and 44% had FPG < 100 mg/dL by W12, W24 and W48. 49% (21/43) of pts taking antidiabetic medication at BL stopped or reduced the dose by W48; 23% (10/43) increased dose or number of medications. BP or glycemic status change did not correlate with mUFC change from BL. Many CD pts with comorbid HTN or DM had improvements in these parameters during osilodrostat therapy. Close follow-up is needed as concomitant medication adjustments are required in some pts, including those with improvements in HTN or DM. Osilodrostat is effective at improving clinical signs and may alleviate hypercortisolism-associated treatment burden, which could benefit some CD pts." @default.
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• W4280490525 date "2022-05-01" @default.
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• W4280490525 title "Abstract #1183049: Hypertension (HTN) and Diabetes (DM) Improvement During Osilodrostat Therapy in Patients with Cushing’s Disease (CD): Analyses from the Phase III LINC 3 study" @default.
• W4280490525 doi "https://doi.org/10.1016/j.eprac.2022.03.273" @default.
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