Korlym® provided improvements in symptoms of hypercortisolism
Improvement in oGTT glucose from baseline1
Korlym provided rapid and significant improvement in insulin sensitivity:
- Reduction in AUCglucose of ≥25% in 60% of patients (assessed by oGTT)1
- Improvement in glucose from baseline seen as early as 6 weeks (P=.004)1
- Rapid and significant improvements in AUCinsulin, as well as demonstrated improvements in insulin sensitivity1
Mean reduction in HbA1c from baseline1,2
Significant reduction in HbA1c of 1.1% by week 24/ET (C-DM all; ET=early termination; P<.001)
- In a subset of patients with HbA1c >7% at baseline, a mean reduction of approximately 2% was achieved by week 242
Additional findings included†:
Significant weight loss observed*
Reduction in body weight from baseline1,4
There was a significant reduction of 5.7% in mean body weight from baseline in patients treated with Korlym at week 24/ET (P<.001)1,4
- ≥5% reduction in more than half of patients (n=24/46)1
- ≥10% reduction in more than a quarter of patients (n=12/46)1
In addition, mean total fat mass decreased by 13.9% (P<.001).4
Significant reduction in waist circumference*
Marked decrease in waist circumference from baseline at week 24 (P<.001)1
Reduction of 8.4 ± 5.9 cm for men (P<.001)1
Reduction of 6.8 ± 5.8 cm for women (P<.001)1
†Because of the variability in clinical presentation and variability of response in this open-label study, it is uncertain whether these changes could be ascribed to the effects of Korlym.
C-DM, patients with CS and T2DM/IGT; IGT, impaired glucose tolerance; oGTT, oral Glucose Tolerance Test; T2DM, type 2 diabetes mellitus.
*Study design: SEISMIC (Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing’s Syndrome) was a phase 3, uncontrolled, open-label, 24-week, multicenter clinical study of 50 subjects with endogenous Cushing syndrome. All 50 subjects had clinically significant hypercortisolism. Subjects received 300 mg to 1200 mg of Korlym per day for up to 24 weeks. Forty-three patients had Cushing disease, of which 42 had previously undergone pituitary surgery. Four patients had ectopic adrenocorticotropic hormone (ACTH) secretion, and 3 had adrenal carcinoma. Forty-six subjects received at least 30 days of dosing during the 24-week study period and were included in a modified intent-to-treat analysis.