Table 1.
Characteristics of subjects and treatment with easypod™.
Total (n = 238) | Prepubertal (n = 212) | Pubertal (n = 26) | GHD (n = 144) | SGA (n = 86) | |
---|---|---|---|---|---|
Age | |||||
At inclusion, mean years ± s.d. | 9.0 ± 3.3 | 8.5 ± 3.1 | 13.4 ± 3.1 | 9.9 ± 3.4 | 7.7 ± 2.7 |
At start of treatment with easypod™, mean years ± s.d. | 7.9 ± 3.2 | 7.3 ± 2.9 | 12.5 ± 1.8 | 8.7 ± 3.3 | 6.6 ± 2.5 |
Gender, n (%) | |||||
Male | 123 (51.7) | 112 (52.8) | 11 (42.3) | 78 (54.2) | 45 (52.3) |
Female | 115 (48.3) | 100 (47.2) | 15 (57.7) | 66 (45.8) | 41 (47.7) |
Ethnicity, n (%) | |||||
Caucasian | 224 (94.1) | 199 (93.9) | 25 (96.2) | 135 (93.8) | 81 (94.2) |
African | 1 (0.4) | 1 (0.5) | 0 (0.0) | 1 (0.7) | 0 (0.0) |
Asian | 3 (1.3) | 3 (1.4) | 0 (0.0) | 2 (1.4) | 1 (1.2) |
Other | 10 (4.2) | 9 (4.8) | 1 (3.8) | 6 (4.2) | 4 (4.7) |
Auxological data before starting treatment | |||||
Height SDS, mean (s.d.) | −2.6 (0.8) | −2.6 (0.7) | −2.2 (1.1) | −2.5 (0.8) | −2.6 (0.6) |
Weight SDS, mean (s.d.) | −1.3 (0.9) | −1.3 (0.9) | 0.9 | −1.1 (1.0) | −1.5 (0.8) |
HV SDS, mean (s.d.) | −2.0 (1.7) | −2.0 (1.6) | −2.3 (2.3) | −2.4 (1.7) | −1.5 (1.5) |
BMI SDS | 0.2 (1.4) | 0.2 (1.4) | 0.3 (1.3) | 0.3 (1.5) | −0.2 (1.1) |
Bone age, years (s.d.) | 6.0 (3.3) | 5.4 (2.9) | 11.0 (1.3) | 6.7 (3.4) | 4.8 (2.7) |
Treatment with r-hGH | |||||
Prescribed dose, mean mg/kg/day (s.d.) | 0.032 (0.005) | 0.032 (0.005) | 0.033 (0.006) | 0.030 (0.004) | 0.035 (0.004) |
Percentage of reported changes in the prescribed doses over the treatment period, mean % ± s.d. | 61.7 ± 20.2 | 62.0 ± 20.5 | 58.8 ± 18.1 | 59.1 ± 22.4 | 66.1 ± 15.6 |
Duration of treatment period, mean months (s.d.) | 26.6 (11.6) | 27.2 (11.7) | 22.0 (8.9) | 27.4 (11.9) | 25.5 (10.7) |
Person who performed majority of injections, n (%) | |||||
Parents/legal guardian | 161 (67.6) | 154 (72.6) | 7 (26.9) | 85 (59.0) | 70 (81.4) |
Under parent supervision | 54 (22.7) | 42 (19.8) | 12 (46.2) | 40 (27.8) | 12 (14.0) |
Self-injections | 17 (7.1) | 11 (5.2) | 6 (23.1) | 14 (9.7) | 3 (3.5) |
Not available | 6 (2.5) | 5 (2.4) | 1 (3.8) | 5 (3.5) | 1 (1.2) |
Missed some injection over the treatment period, n (%) | 195 (81.9) | 173 (81.6) | 22 (84.6) | 115 (79.9) | 73 (84.9) |
Reasons for missing injections, n (%) | |||||
Forgot injection | 152 (78.0) | 137 (79.2) | 15 (68.2) | 90 (78.3) | 55 (75.3) |
Holidays/long weekend/not sleeping at home | 101 (51.8) | 90 (52.0) | 11 (50.0) | 57 (49.6) | 42 (57.5) |
Medical reasons | 6 (3.1) | 5 (2.9) | 1 (4.6) | 4 (3.5) | 2 (2.7) |
Tired of injections | 7 (3.6) | 5 (2.9) | 2 (9.1) | 4 (3.5) | 3 (4.1) |
Technical problems with easypod™ | 14 (7.2) | 11 (6.4) | 3 (13.6) | 6 (5.2) | 8 (11.0) |
Forgot drug/Easypod™ | 15 (7.7) | 12 (6.9) | 3 (13.6) | 10 (8.7) | 5 (6.9) |
Ran out of needle/cartridge | 7 (3.6) | 7 (4.1) | 0 (0.0) | 3 (2.6) | 4 (5.5) |
Others | 20 (10.3) | 18 (10.4) | 2 (9.1) | 11 (9.6) | 7 (9.6) |
BMI, body mass index; GHD, growth hormone deficiency; HV, height velocity; s.d., standard deviation; SDS, standard deviation score; SGA, small for gestational age.