Table 3. Patient decreases in LDL-C from Phase 3 study–derived baseline to final visit assessment.
| Responder Parameter, N (%) | Lomitapide MTD at Visit 1 |
FAS (N = 5) |
||
|---|---|---|---|---|
| 10 mg (n = 1)a | 20 mg (n = 3) | 40 mg (n = 1) | ||
| > 15% Decrease in LDL-C | 1 | 2 | 1 | 4 |
| > 25% Decrease in LDL-C | 1 | 2 | 1 | 4 |
| > 50% Decrease in LDL-C | 1 | 0 | 0 | 1 |
| LDL-C < 100 mg/dL | 1 | 1 | 0 | 2 |
| LDL-C < 70 mg/dL | 0 | 0 | 0 | 0 |
FAS, full analysis set; LDL-C, low-density lipoprotein cholesterol; MTD, maximum tolerated dose
a
Final assessment was made at the termination of study at Day 349 for this patient