Osilodrostat dose impact on efficacy/safety in Cushing's disease: large, pooled analysis of LINC 2, 3, and 4
Authors' conclusion
In this analysis of the largest and longest prospective interventional studies of an adrenal steroidogenesis inhibitor to date, osilodrostat provided rapid and sustained mUFC control, with dose decreases possible over the long term. AE frequency generally decreased over time, with no relationship with osilodrostat dose. Personalized adjustment of osilodrostat dose is important to optimize outcomes for patients with Cushing's disease.
Study context
- Population
- Patients with CD treated with osilodrostat in Phase II LINC 2 and Phase III LINC 3 and LINC 4
- Participants
- 229 patients
- Outcome
- mUFC control (not exceeding upper limit of normal)
Methodological detailsindividual-patient data, core and extension periods, placebo periods excluded
- Individual-patient data
- Core and extension periods
- Placebo periods excluded
Pooled result
As reported in the abstract
Median time to first mean urinary free cortisol (mUFC) control (longer with increasing baseline mUFC)
35 days
Most common dose for first mUFC control: 4 mg/day
33.2% of patients
Median dose for first mUFC control
10 mg/day
range 2–60
Further pooled results
Osilodrostat exposure
- Median average dose per patient
- 6.8 mg/day
- Mean treatment duration
- 113.7 weeks (SD 73.1)
Safety
- Discontinued because of adverse events (AEs)
- 37 (16.2%)
- AEs generally more often during dose titration (baseline to week 12) than long-term treatment (week >12), but could occur at any time
Original publication
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