Table 2.
Biochemical response rates at the end of the core study and after crossover, by treatment group
| Crossed over to pasireotide LAR (N = 81) | Crossed over to octreotide LAR (N = 38) | |||
|---|---|---|---|---|
| n (%) | 95 % exact CI | n (%) | 95 % exact CI | |
| GH <2.5 μg/L and normal IGF-1 | ||||
| End of core (month 12) | 1 (1.2) | (0.0–6.7) | 0 (0.0) | (0.0–9.3) |
| Month 3 | 14 (17.3) | (9.8, 27.3) | 1 (2.6) | (0.1, 13.8) |
| Month 6 | 17 (21.0) | (12.7, 31.5) | 1 (2.6) | (0.1, 13.8) |
| Month 9 | 18 (22.2) | (13.7, 32.8) | 2 (5.3) | (0.6, 17.7) |
| Month 12 | 14 (17.3) | (9.8, 27.3) | 0 (0.0) | – |
| GH <2.5 μg/L | ||||
| End of core (month 12) | 35 (43.2) | (32.2–54.7) | 8 (21.1) | (9.6–37.3) |
| Month 3 | 40 (49.4) | (38.1, 60.7) | 11 (28.9) | (15.4, 45.9) |
| Month 6 | 35 (43.2) | (32.2, 54.7) | 12 (31.6) | (17.5, 48.7) |
| Month 9 | 44 (54.3) | (42.9, 65.4) | 12 (31.6) | (17.5, 48.7) |
| Month 12 | 36 (44.4) | (33.4, 55.9) | 9 (23.7) | (11.4, 40.2) |
| Normal IGF-1 | ||||
| End of core (month 12) | 5 (6.2) | (2.0–13.8) | 2 (5.3) | (0.6–17.7) |
| Month 3 | 16 (19.8) | (11.7, 30.1) | 3 (7.9) | (1.7, 21.4) |
| Month 6 | 25 (30.9) | (21.1, 42.1) | 3 (7.9) | (1.7, 21.4) |
| Month 9 | 24 (29.6) | (20.0, 40.8) | 4 (10.5) | (2.9, 24.8) |
| Month 12 | 22 (27.2) | (17.9, 38.2) | 2 (5.3) | (0.6, 17.7) |
One patient who crossed over to pasireotide LAR had GH <2.5 μg/L and normal IGF-1 at month 12 of the core study; this patient had elevated GH and IGF-1 at last assessment prior to the extension phase. CI confidence interval