Over 10 years of treatment data
Korlym has been prescribed for the treatment of hyperglycemia secondary to hypercortisolism in patients with endogenous Cushing syndrome for over a decade.1
SEISMIC safety data
Most adverse events (AEs) were mild to moderate in severity in the Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing Syndrome (SEISMIC) study.2
The most frequently reported adverse reactions (reported in ≥20% of patients, regardless of relationship to Korlym) were nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, and endometrial hypertrophy. Drug-related adverse events resulted in dose interruption or reduction in study drug in 40% of patients.
The frequency of the 4 most commonly reported AEs did not increase over time4,5
Nausea
Fatigue
Headache
Hypokalemia
The number of serious AEs did not rise with dose increases over time5
Rates of cortisol withdrawal–related AEs did not increase as the average dose increased
Rates of cortisol withdrawal–related AEs declined the longer patients were receiving treatment
COMMONLY OCCURRING (≥10%) AES IN PATIENTS RECEIVING KORLYM4
| AE | % Patients (N=50) |
|---|---|
| Nausea | 48% |
| Fatigue | 48% |
| Headache | 44% |
| Decreased blood potassium | 34% |
| Arthralgia | 30% |
| Vomiting | 26% |
| Peripheral edema | 26% |
| Hypertension | 24% |
| Dizziness | 22% |
| Decreased appetite | 20% |
| Endometrial hypertrophy | 38%* |
| Dry mouth | 18% |
| Abnormal thyroid function | 18% |
| Back pain | 16% |
| Dyspnea | 16% |
| Pain | 14% |
| Myalgia | 14% |
| Sinusitis | 14% |
| Diarrhea | 12% |
| Pain in extremity | 12% |
| Nasopharyngitis | 12% |
| Constipation | 10% |
| Somnolence | 10% |
| Anorexia | 10% |
| Anxiety | 10% |
Drug-related adverse events resulted in dose interruption or reduction in study drug in 40% of patients4
*Based on a denominator of 26 women who had baseline and end-of-trial transvaginal ultrasound measurements.4
CATALYST safety data
No new safety signals were observed in CATALYST—AEs were consistent with the SEISMIC pivotal trial3
TREATMENT-EMERGENT ADVERSE EVENTS (TEAE) REPORTED IN >10% OF PATIENTS
| TEAE, % (n) | Korlym (n=91) | Placebo (n=43) |
|---|---|---|
| Patients with at least one event | 94.5% (86) | 83.7% (36) |
| Hypokalemia | 29.7% (27) | 0.0% (0) |
| Fatigue | 20.9% (19) | 16.3% (7) |
| Nausea | 20.9% (19) | 11.6% (5) |
| Vomiting | 15.4% (14) | 7.0% (3) |
| Peripheral edema | 15.4% (14) | 2.3% (1) |
| Headache | 12.1% (11) | 11.6% (5) |
| Diarrhea | 11.0% (10) | 7.0% (3) |
| Dizziness | 11.0% (10) | 7.0% (3) |
31.9% of patients treated with Korlym and 4.7% of patients treated with placebo experienced a serious TEAE3
28.6% of patients treated with Korlym and 2.3% of patients treated with placebo experienced a TEAE leading to study drug discontinuation3
26.4% and 13.2% of patients treated with Korlym and 11.6% and 2.3% of patients treated with placebo experienced a TEAE leading to dose interruption or dose reduction, respectively3
No cases of adrenal insufficiency were reported3