Table 1.
Baseline characteristics of 166 patients at time of enrollment in SODA Study
| Injection administered by | |||||
|---|---|---|---|---|---|
| Patient always (n = 26) | Partner always (n = 41) | HCP always (n = 58) | Combination/other (n = 41) | All patients (n = 166) | |
| Gender, % M/F | 35/65 | 59/42 | 43/57 | 66/34 | 51/49 |
| Mean age, years (range) | 52 ± 12 (23–73) | 52 ± 16 (22–84) | 49 ± 17 (13–86) | 49 ± 13 (25–73) | 50 ± 15 (13–86) |
| Time since diagnosis, months (mean) | 99 ± 77 | 65 ± 63 | 98 ± 117 | 96 ± 105 | 89 ± 98 |
| Etiology of acromegaly, n (%)a | |||||
| Pituitary adenoma | 26 (100) | 41 (100) | 56 (97) | 40 (98) | 163 (98) |
| McCune-Albright syndrome | 0 | 1 (2) | 1 (2) | 0 | 2 (1) |
| Otherb | 0 | 0 | 1 (2) | 1 (2) | 2 (1) |
| IGF-I level measuredc (n) | 25 | 36 | 52 | 40 | 153 |
| High, n (%) | 10 (40) | 15 (42) | 28 (54) | 23 (58) | 76 (50) |
| Normal, n (%) | 14 (56) | 21 (58) | 23 (44) | 16 (40) | 74 (48) |
| Low, n (%) | 1 (4) | 0 | 1 (2) | 1 (3) | 3 (2) |
| Unknown, n (%) | 1 (4) | 5 (12) | 6 (15) | 1 (3) | 13 (8) |
| Peak glucose-suppression GH level (n) | 6 | 4 | 6 | 8 | 24 |
| Median, ng/mL | 1.1 | 0.7 | 2.5 | 2.0 | 1.8 |
| Trough GH ≤2.5 ng/mL, n (%) | 5 (83) | 3 (75) | 3 (50) | 5 (63) | 16 (67) |
| Trough GH ≤1 ng/mL, n (%) | 3 (50) | 3 (75) | 2 (33) | 3 (38) | 11 (46) |
| Prior pituitary surgery, n (%) | 24 (92) | 29 (71) | 44 (76) | 36 (88) | 133 (80) |
| Prior radiation therapy, n (%) | 2 (8) | 5 (12) | 15 (26) | 12 (29) | 34 (20) |
| Prior medical therapy, n (%)d,e | 20 (77) | 28 (68) | 45 (78) | 30 (73) | 123 (74) |
| SSA | 15 (58) | 19 (46) | 39 (67) | 24 (59) | 97 (58) |
| Short-acting octreotide | 0 | 1 (2) | 12 (21) | 2 (5) | 15 (9) |
| Long-acting octreotide | 15 (58) | 18 (44) | 27 (47) | 22 (54) | 82 (49) |
| Dopamine agonist | 9 (35) | 17 (42) | 14 (24) | 11 (27) | 51 (31) |
| Pegvisomant | 5 (19) | 2 (5) | 12 (21) | 9 (22) | 28 (17) |
| None (treatment-naïve) | 2 (8) | 7 (17) | 5 (9) | 5 (12) | 19 (11) |
Given the non-interventional nature of the study, not all datapoints are available for all patients
GH growth hormone, GHRH growth-hormone releasing hormone, IGF-I insulin-like growth factor-1, SSA somatostatin analog
aCategories are not mutually exclusive; two subjects were categorized as having a GH-secreting macroadenoma and a pituitary adenoma; one subject had a pituitary adenoma and McCune-Albright syndrome
bPituitary enlargement with high IGF-I, suggesting a probable GHRH-secreting pinealoma
cThe proportion of IGF-I samples analyzed centrally was 20 % at enrollment and 27 % at 12 months; the remaining samples were analyzed in local institutional laboratories. Values determined to be high, normal or low by investigator
dValues based on case report forms which did not identify patients using lanreotide depot
eTherapies were not mutually exclusive