Baseline characteristics of patients
| Characteristic . | Amlodipine (n = 30) . | Placebo (n = 29) . | All patients (n = 59) . |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 17 (57) | 12 (41) | 29 (49) |
| Age, y (range) | 23.3 ± 7.7 (12-38) | 23.5 ± 10.2 (8-49) | 23.4 ± 9.0 (8-49) |
| Weight, kg | 55.8 ± 11.4 | 55.9 ± 17.5 | 55.8 ± 14.6 |
| Body mass index, kg/m2 | 22.1 ± 3.3 | 22.3 ± 4.1 | 22.2 ± 3.7 |
| Hepatitis C, n (%) | 9 (30) | 6 (21) | 15 (25) |
| Splenectomy, n (%) | 5 (17) | 2 (7) | 7 (12) |
| Pretransfusional hemoglobin, g/dL | 9.4 ± 1.0 | 9.5 ± 1.0 | 9.5 ± 1.0 |
| Time since start of chelation therapy, y | 19.7 ± 6.7 | 20.3 ± 9.5 | 20.0 ± 8.1 |
| Chelation therapy at baseline, n (%) | |||
| DFO | 3 (10) | 4 (14) | 7 (12) |
| DFP | 5 (16) | 6 (21) | 11 (19) |
| DFX | 17 (57) | 13 (45) | 30 (51) |
| DFO + DFP | 5 (16) | 5 (17) | 10 (16) |
| DFO + DFX | 0 | 1 (3) | 1 (2) |
| Serum ferritin, ng/mL (median [range]) | 2638 (478-7282) | 1922 (386-13 113) | 2024 (386-13 113) |
| Myocardial T2*, ms (median [range]) | 34.1 (2.8-43.8) | 34.1 (6.8-42.7) | 34.1 (2.8-43.8) |
| Myocardial iron concentration, mg/g dry weight (median [range]) | 0.61 (0.45-12.81) | 0.61 (0.46-4.34) | 0.61 (0.45-12.81) |
| Left ventricular ejection fraction, % | 67.7 ± 5.5 | 67.1 ± 6.6 | 67.4 ± 6.0 |
| Myocardial T2* categories, n (%) | |||
| <10 ms | 4 (13) | 2 (7) | 6 (10) |
| 10 to ≤20 ms | 4 (13) | 2 (7) | 6 (10) |
| 20 to <35 ms | 7 (23) | 11 (38) | 18 (31) |
| ≤35 ms | 15 (50) | 14 (48) | 29 (49) |
| LIC, mg/g, median (range) | 11.3 (1.9-40.0) | 9.2 (1.5-33.3) | 9.6 (1.5-40.0) |
| LIC categories, n (%) | |||
| <7 mg/g | 10 (33) | 12 (42) | 22 (37) |
| 7 to ≤15 mg/g | 8 (27) | 9 (31) | 17 (29) |
| >15 mg/g | 12 (40) | 8 (28) | 20 (34) |
| Characteristic . | Amlodipine (n = 30) . | Placebo (n = 29) . | All patients (n = 59) . |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 17 (57) | 12 (41) | 29 (49) |
| Age, y (range) | 23.3 ± 7.7 (12-38) | 23.5 ± 10.2 (8-49) | 23.4 ± 9.0 (8-49) |
| Weight, kg | 55.8 ± 11.4 | 55.9 ± 17.5 | 55.8 ± 14.6 |
| Body mass index, kg/m2 | 22.1 ± 3.3 | 22.3 ± 4.1 | 22.2 ± 3.7 |
| Hepatitis C, n (%) | 9 (30) | 6 (21) | 15 (25) |
| Splenectomy, n (%) | 5 (17) | 2 (7) | 7 (12) |
| Pretransfusional hemoglobin, g/dL | 9.4 ± 1.0 | 9.5 ± 1.0 | 9.5 ± 1.0 |
| Time since start of chelation therapy, y | 19.7 ± 6.7 | 20.3 ± 9.5 | 20.0 ± 8.1 |
| Chelation therapy at baseline, n (%) | |||
| DFO | 3 (10) | 4 (14) | 7 (12) |
| DFP | 5 (16) | 6 (21) | 11 (19) |
| DFX | 17 (57) | 13 (45) | 30 (51) |
| DFO + DFP | 5 (16) | 5 (17) | 10 (16) |
| DFO + DFX | 0 | 1 (3) | 1 (2) |
| Serum ferritin, ng/mL (median [range]) | 2638 (478-7282) | 1922 (386-13 113) | 2024 (386-13 113) |
| Myocardial T2*, ms (median [range]) | 34.1 (2.8-43.8) | 34.1 (6.8-42.7) | 34.1 (2.8-43.8) |
| Myocardial iron concentration, mg/g dry weight (median [range]) | 0.61 (0.45-12.81) | 0.61 (0.46-4.34) | 0.61 (0.45-12.81) |
| Left ventricular ejection fraction, % | 67.7 ± 5.5 | 67.1 ± 6.6 | 67.4 ± 6.0 |
| Myocardial T2* categories, n (%) | |||
| <10 ms | 4 (13) | 2 (7) | 6 (10) |
| 10 to ≤20 ms | 4 (13) | 2 (7) | 6 (10) |
| 20 to <35 ms | 7 (23) | 11 (38) | 18 (31) |
| ≤35 ms | 15 (50) | 14 (48) | 29 (49) |
| LIC, mg/g, median (range) | 11.3 (1.9-40.0) | 9.2 (1.5-33.3) | 9.6 (1.5-40.0) |
| LIC categories, n (%) | |||
| <7 mg/g | 10 (33) | 12 (42) | 22 (37) |
| 7 to ≤15 mg/g | 8 (27) | 9 (31) | 17 (29) |
| >15 mg/g | 12 (40) | 8 (28) | 20 (34) |
Values expressed as mean ± standard deviation, unless otherwise specified.
DFO, deferoxamine; DFP, deferiprone; DFX, deferasirox.