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Table 2 Biochemical response rates at the end of the core study and after crossover, by treatment group

From: Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study

 

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)

  1. 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