Table 1.
Summary of patient demographic and acromegaly baseline characteristics for the double-blind placebo-controlled period
| Characteristics | OOC (n = 28) |
Placebo (n = 28) |
Overall (N = 56) |
|---|---|---|---|
| Sex, n (%) | |||
| Male | 12 (42.9) | 14 (50.0) | 26 (46.4) |
| Female | 16 (57.1) | 14 (50.0) | 30 (53.6) |
| Race, n (%)a | |||
| Asian | 1 (3.6) | 2 (7.1) | 3 (5.4) |
| Black/African or African American | 0 | 1 (3.6) | 1 (1.8) |
| White | 27 (96.4) | 24 (85.7) | 51 (91.1) |
| Other | 0 | 1 (3.6) | 1 (1.8) |
| Age at screeningb, y | |||
| Mean (SD) | 55.3 (11.97) | 54.2 (10.96) | 54.7 (11.38) |
| Median | 57.0 | 54.5 | 57.0 |
| Weight at screening, kg | |||
| Mean (SD) | 83.4 (17.22) | 91.6 (20.48) | 87.5 (19.19) |
| Median | 81.9 | 95.5 | 84.1 |
| BMI at screening, kg/m2 | |||
| Mean (SD) | 29.1 (6.26) | 31.0 (5.58) | 30.0 (5.96) |
| Median | 27.8 | 31.2 | 28.8 |
| Diabetes mellitus, n (%) | 2 (7.1) | 4 (14.3) | 6 (10.7) |
| Duration of acromegaly, n (%), y | |||
| < 10 | 15 (53.6) | 20 (71.4) | 35 (62.5) |
| 10-< 20 | 8 (28.6) | 5 (17.9) | 13 (23.2) |
| ≥ 20 | 5 (17.9) | 3 (10.7) | 8 (14.3) |
| Prior acromegaly surgery, n (%) | 25 (89.3) | 24 (85.7) | 49 (87.5) |
| Symptom burden, n (%)c | |||
| ≥ 1 | 23 (82.1) | 24 (85.7) | 47 (83.9) |
| ≥ 2 | 18 (64.3) | 19 (67.9) | 37 (66.1) |
| ≥ 3 | 10 (35.7) | 14 (50.0) | 24 (42.9) |
| Screening average IGF-1, n (%) | |||
| ≤ 1.0 × ULN | 28 (100) | 28 (100) | 56 (100) |
| > 1.0-< 1.3 × ULN | 0 | 0 | 0 |
| Baseline average IGF-1, n (%)d | |||
| ≤ 1.0 × ULN | 27 (96.4) | 23 (82.1) | 50 (89.3) |
| > 1.0-< 1.3 × ULN | 1 (3.6) | 5 (17.9) | 6 (10.7) |
| Mean baseline IGF-1 × ULN (SD) | 0.8 (0.157) | 0.84 (0.210) | 0.82 (0.185) |
| Baseline GH, n (%)e | |||
| ≤ 1.0 ng/mL | 23 (82.1) | 21 (75.0) | 44 (78.6) |
| > 1.0-< 2.5 ng/mL | 4 (14.3) | 4 (14.3) | 8 (14.3) |
| ≥ 2.5 ng/mL | 1 (3.6) | 3 (10.7) | 4 (7.1) |
| Prior injectable treatment for acromegaly, n (%) | |||
| Octreotide | 19 (67.8) | 17 (60.7) | 36 (64.2) |
| Lanreotide | 9 (32.1) | 11 (39.3) | 20 (35.7) |
| Prior injectable treatment overall dose, n (%)f | |||
| Low | 6 (21.4) | 5 (17.9) | 11 (19.6) |
| Middle | 8 (28.6) | 11 (39.3) | 19 (33.9) |
| High | 14 (50.0) | 12 (42.9) | 26 (46.4) |
Abbreviations: BMI, body mass index; IGF-1, insulin-like growth factor 1; GH, growth hormone; OOC, oral octreotide capsules; ULN, upper limit of normal.
a Patients could have selected multiple race categories.
b Age in years = year of study day 0 – year of birth.
c Symptom burden reflects the number of ongoing acromegaly symptoms at screening on the acromegaly history form.
d Based on the average of the 2 assessments within 2 weeks prior to random assignment.
e Screening visit 1. If screening visit 1 data were missing, then baseline data were used.
f Low dose: octreotide 10 mg every 4 weeks; lanreotide 60 mg every 4 weeks or 120 mg every 8 weeks. Medium dose: octreotide 20 mg every 4 weeks; lanreotide 90 mg every 4 weeks or 120 mg every 6 weeks. High dose: octreotide 30 mg every 4 weeks; lanreotide 120 mg every 4 weeks. Patients were stratified based on the grouping of mid to high and low prior somatostatin receptor ligand doses.