Introduction
Patients and methods
Study protocol
Diabetes and no-diabetes groups
Concomitant therapies
Laboratory tests and MRI evaluations
Safety evaluations
Statistical methods
Results
Baseline characteristics and demographic data
Country | Number of patients (%) |
---|---|
Germany | 480 (27.2) |
Italy | 340 (19.3) |
France | 276 (15.7) |
Spain | 199 (11.3) |
USA | 120 (6.8) |
Netherlands | 108 (6.1) |
Greece | 53 (3.0) |
Great Britain | 48 (2.7) |
Sweden | 37 (2.1) |
Denmark | 32 (1.8) |
Belgium | 28 (1.6) |
Slovakia | 23 (1.3) |
Portugal | 9 (0.5) |
Hungary | 7 (0.4) |
Austria | 2 (0.1) |
Variable, unit | Diabetes (n = 510) | No-diabetes (n = 1,252) | P-value |
---|---|---|---|
Age at diagnosis, y | 46.7 ± 13.45 | 39.7 ± 12.93 | 0.0001 |
Sex: M/F (%) | 219/291 (43/57) | 673/579 (54/46) | 0.0001 |
Weight, kg | 89.2 ± 19.12 | 87.4 ± 19.85 | NA |
Height, cm | 168.7 ± 10.96 | 173.0 ± 11.70 | NA |
BMI, kg/m2 | 31.2 ± 6.00 | 28.6 ± 5.00 | 0.0001 |
Age at PEGV start, y | 55.4 ± 13.47 | 49.1 ± 13.75 | 0.0001 |
Cause of GH hypersecretion (%) | |||
Microadenoma | 40 (8) | 61 (5) | |
Macroadenoma | 170 (34) | 439 (36) | |
Pituitary adenoma (not specified) | 288 (57) | 719 (59) | |
Extrapituitary | 1 (0.2) | 3 (0.2) | |
Not known | 3 (0.6) | 7 (0.6) | |
Hypertension (%) | |||
Yes | 347 (68.7) | 472 (40.2) | 0.0001 |
No | 158 (31.2) | 703 (59.8) | 0.0001 |
CVD (%) | |||
Yes | 364 (71.4) | 513 (41) | 0.0001 |
No | 141 (27.7) | 672 (53.7) | 0.0001 |
Hyperlipidemia, n (%) | 48 (9.4) | 71 (5.6) | 0.0045 |
IGF-I > ULN, n (% of patients with available samples) | 281 (83.1) | 672 (85.8) | NS |
Diabetes (n = 510) | No-diabetes (n = 1,252) | All (n = 1,762) | P-value | |
---|---|---|---|---|
Medical treatment only | 103 (20.2%) | 185 (14.8%) | 288 (16.3%) | < 0.01 |
Surgery only | 21 (4.1%) | 50 (4.0%) | 71 (4.0%) | NS |
Radiotherapy only | 0 | 1 (0.1%) | 1 (0.1%) | NA |
Medical treatment and surgery | 212 (41.6%) | 626 (50.0%) | 838 (47.6%) | < 0.01 |
Medical treatment and radiotherapy | 16 (3.1%) | 24 (1.9%) | 40 (2.3%) | NS |
Surgery and radiotherapy | 12 (2.4%) | 21 (1.7%) | 33 (1.9%) | NS |
Medical treatment, surgery and radiotherapy | 126 (24.7%) | 293 (23.4%) | 419 (23.8%) | NS |
Cross-sectional analysis
Longitudinal analyses
Analysis at 1 year
Analysis at 4 years
Changes in diabetes treatment status
DM treatment category | Baseline n = 429 | Year 1 n = 322 | Year 4 n = 277 | |
---|---|---|---|---|
All Patients, n (%) | 1 | 244 (57) | 143 (44) | 104 (37) |
2 | 49 (11) | 70 (22) | 66 (24) | |
3 | 136 (32) | 109 (34) | 108 (39) | |
PEGV monotherapy | 1 | 117 (60) | 56 (43) | 43 (36) |
2 | 23 (12) | 31 (24) | 28 (24) | |
3 | 56 (28) | 44 (36) | 47 (40) | |
Combination therapy PEGV + SSA | 1 | 79 (53) | 58 (48) | 38 (38) |
2 | 18 (12) | 21 (17) | 26 (26) | |
3 | 51 (34) | 41 (34) | 35 (35) |
Safety evaluations
N | Patients with AEs, n | Treatment-emergent AEs, n | Patients with SAEs, n | Treatment-emergent SAEs, n | |
---|---|---|---|---|---|
Diabetes | 510 | 258 | 965 (95) | 76 | 194 (12) |
No-diabetes | 1252 | 568 | 2094 (305) | 125 | 368 (30) |
Total | 1762 | 826 | 3059 (400) | 201 | 562 (42) |