Table 1 (a) Baseline variables in the different randomisation arms and by the Haptoglobin genotypes. (b) Baseline variables by Hp genotype.
Total | Overall | Hp2-2 group | Non-Hp2-2 group | ||||
|---|---|---|---|---|---|---|---|
Vitamin E | Placebo | Vitamin E | Placebo | Vitamin E | Placebo | ||
(a) Baseline variables in the different randomisation arms and by the Haptoglobin genotypes | |||||||
Number (%) | 166 | 84 (50.6) | 82 (49.4) | 42 (25.30) | 44 (26.51) | 42 (25.30) | 38 (22.89) |
Age years, mean (SD) | 56 (10) | 55 (10) | 57 (10) | 54 (9) | 56 (11) | 57 (11) | 59 (9) |
Gender | |||||||
Female, n (%) | 83 (50.00) | 41 (49.40) | 42 (50.60) | 23 (54.76) | 24 (54.55) | 18 (42.86) | 18 (47.37) |
Male, n (%) | 83 (50.00) | 43 (51.81) | 40 (48.19) | 19 (45.24) | 20 (45.45) | 24 (57.14) | 20 (52.63) |
Ethnicity | |||||||
Chinese, n (%) | 103 (62.05) | 56 (54.37) | 47 (45.63) | 21 (50.00) | 22 (50.00) | 35 (83.33) | 25 (65.79) |
Malay, n (%) | 24 (14.46) | 11 (45.83) | 13 (54.17) | 5 (11.90) | 7 (15.91) | 6 (14.29) | 6 (15.79) |
Indian, n (%) | 39 (23.49) | 17 (43.59) | 22 (56.41) | 16 (38.10) | 15 (34.09) | 1 (2.38) | 7 (18.42) |
Duration of DM years, Median (IQR) | 10 (13) | 10 (13) | 10.5 (12.3) | 9.5 (14) | 10 (10.5) | 10 (11) | 11 (14) |
Duration of Hypertension years, Median (IQR) | 6.5 (13) | 3 (12) | 8.5 (15.3) | 2 (10) | 8 (12) | 9 (13) | 10.5 (17) |
Duration of Hyperlipidaemia years, Median (IQR) | 7 (11) | 6 (12) | 8.5 (10.5) | 3 (9) | 8 (9) | 8 (14) | 9 (16) |
Number of patients with known stable IHD, N(%) | 13 (7) | 6 (7) | 7 (8.5) | 4 (9.5) | 3 (6.8) | 2 (4.8) | 4 (10) |
Physical measurements | |||||||
BMI Kg/m2, mean (SD) | 27.37 (4.94) | 27.36 (4.92) | 27.39 (5.01) | 27.44 (5.38) | 28.08 (5.24) | 27.26 (4.47) | 26.58 (4.65) |
Waist circumference cm, mean (SD) | 93.81 (10.55) | 93.51 (10.04) | 94.13 (11.12) | 92.48 (9.31) | 95.32 (11.14) | 94.52 (10.73) | 92.73 (11.06) |
Systolic BP (Peripheral) mmHg, mean (SD) | 134 (15) | 135.64 (14.86) | 132.32 (14.93) | 134 (12) | 133 (16) | 137 (17) | 131 (14) |
Diastolic BP (Peripheral) mmHg, mean (SD) | 76 (8) | 76.64 (8.52) | 74.93 (8.12) | 77 (9) | 76 (8) | 76 (9) | 74 (8) |
HbA1c %, mean (SD) | 7.92 (1.17) | 7.83 (1.13) | 8.02 (1.21) | 7.81 (1.26) | 8.13 (1.42) | 7.84 (1.00) | 7.90 (0.91) |
Lipid parameters | |||||||
Total cholesterol mmol/L, Median (IQR) | 4.1 (1.2) | 4.2 (1.2) | 3.9 (1.0) | 4.25 (1.3) | 4.05 (0.95) | 4.2 (0.89) | 3.75 (0.89) |
LDL cholesterol mmol/L, Median (IQR) | 2.3 (0.9) | 2.4 (1.0) | 2.1 (0.8) | 2.5 (1.2) | 2.3 (1.0) | 2.3 (0.6) | 2.0 (0.6) |
HDL cholesterol mmol/L, Median (IQR) | 1.1 (0.2) | 1.1 (0.3) | 1.1 (0.2) | 1.1 (0.3) | 1.1 (0.2) | 1.0 (0.3) | 1.1 (0.2) |
Triglycerides mmol/L, Median (IQR) | 1.3 (1.0) | 1.3 (1.1) | 1.3 (0.8) | 1.3 (1.2) | 1.3 (0.9) | 1.35 (1.2) | 1.2 (0.8) |
Creatinine μmol/L, mean (SD) | 75.02 (21.08) | 74.29 (21.56) | 75.75 (20.72) | 73.91 (21.14) | 74.56 (20.58) | 74.66 (22.27) | 76.97 (21.07) |
eGFR ml/min/1.73 m2, mean (SD) | 89.57 (21.50) | 91.71 (23.92) | 87.43 (18.70) | 92.91 (20.30) | 88.47 (19.63) | 90.48 (27.39) | 86.37 (17.90) |
Urine ACR mg/mmol, Median (IQR) | 1.55 (3.4) | 1.30 (3.10) | 1.90 (3.55) | 1.3 (3) | 1.9 (5.55) | 1.2 (3) | 2.4 (3.5) |
Haematological parameters | |||||||
Haptoglobin mg/dL, mean (SD) | 116.12 (50.68) | 116.55 (54.55) | 115.68 (46.74) | 107.61 (57.21) | 103.45 (42.81) | 125.47 (50.85) | 129.84 (47.62) |
Ferritin μg/L, Median (IQR) | 72 (112) | 77 (100) | 59 (106) | 66 (76) | 63.5 (119) | 101 (133) | 54.5 (100) |
Transferrin g/L, mean (SD) | 2.48 (0.36) | 2.47 (0.38) | 2.50 (0.34) | 2.53 (0.42) | 2.48 (0.34) | 2.40 (0.33) | 2.51 (0.33) |
Fe Concentration μmol/L, mean (SD) | 13.67 (4.65) | 14.17 (4.96) | 13.10 (4.23) | 14.02 (5.76) | 12.68 (4.76) | 14.31 (4.04) | 13.55 (3.57) |
Haemoglobin g/dL, mean (SD) | 13.17 (1.42) | 13.20 (1.54) | 13.16 (1.32) | 13.16 (1.49) | 13.00 (1.42) | 13.25 (1.62) | 13.42 (1.11) |
Alpha-tocopherol concentration μg/ml, Median (IQR) | 38.67 (32.80) | 39.92 (37.58) | 38.23 (31.12) | 31.55 (27.63) | 32.97 (34.05) | 42.12 (37.67) | 39.78 (22.98) |
Vascular markers | |||||||
hsCRP mg/L, Median (IQR) | 1.45 (3.1) | 1.2 (3.4) | 1.7 (2.7) | 2.1 (3.8) | 1.9 (2.4) | 1 (2.2) | 1.3 (3.2) |
Oxidative Stress index: dROMS, Median (IQR) | 271 (73) | 271 (85) | 274.5 (63) | 287 (109) | 277 (62) | 263 (59) | 267.5 (59) |
Oxidative Stress index: BAPs uM, Median (IQR) | 2221 (327) | 2220 (341) | 2223 (315) | 2225 (362) | 2253 (283) | 2206 (254) | 2189.5 (384) |
CIMT: Average of left and right mm, mean (SD) | 0.65 (0.128) | 0.65 (0.14) | 0.65 (0.12) | 0.627 (0.099) | 0.659 (0.129) | 0.674 (0.162) | 0.645 (0.110) |
CIMT: Maximum of left and right mm, mean (SD) | 0.793 (0.152) | 0.79 (0.16) | 0.79 (0.14) | 0.764 (0.112) | 0.798 (0.154) | 0.823 (0.195) | 0.787 (0.132) |
EndoPAT: Endothelial function - LnRHI, mean (SD) | 0.670 (0.250) | 0.68 (0.24) | 0.66 (0.26) | 0.689 (0.246) | 0.655 (0.280) | 0.677 (0.236) | 0.658 (0.244) |
EndoPAT: Augmentation index at 75bpm %, mean (SD) | 17.7 (15.0) | 18.1 (15.5) | 17.4 (14.6) | 18 (16.5) | 17.8 (15.1) | 18.1 (14.6) | 17.0 (14.0) |
Sphygmocor Systolic BP (Central) mmHg, mean (SD) | 121 (14) | 122 (13) | 120 (14) | 122 (12) | 122 (14) | 123 (14) | 118 (14) |
Sphygmocor Diastolic BP (Central) mmHg, mean (SD) | 79 (9) | 80 (10) | 78 (9) | 80 (10) | 79 (8) | 79 (10) | 77 (9) |
Sphygmocor Pulse Wave Velocity m/s, mean (SD) | 8.34 (1.74) | 8.39 (1.66) | 8.30 (1.84) | 8.20 (1.47) | 8.38 (1.88) | 8.57 (1.81) | 8.21 (1.80) |
SphygmoCor: Augmentation index %, mean (SD) | 29.7 (10.1) | 29.1 (9.7) | 30.3 (10.6) | 29.4 (10.9) | 30.4 (11.2) | 28.7 (8.4) | 30.2 (9.7) |
Oxidised LDL IU/L, Median (IQR) | 53.44 (19.49) | 55.8 (21.5) | 51.7 (20.5) | 56.30 (21.18) | 51.71 (17.37) | 55.17 (21.78) | 51.63 (23.41) |
Medications: Diabetes | |||||||
Sulfonylurea, n (%) | 79 (47.59) | 44 (55.70) | 35 (44.30) | 25 (59.52) | 18 (40.91) | 19 (45.24) | 17 (44.74) |
Metformin, n (%) | 153 (92.17) | 77 (50.33) | 76 (49.67) | 38 (90.48) | 40 (90.91) | 39 (92.86) | 36 (94.74) |
DPP-IV, n (%) | 18 (10.84) | 9 (50.00) | 9 (50.00) | 2 (4.76) | 7 (15.91) | 7 (16.67) | 2 (5.26) |
Long acting Insulin, n (%) | 62 (37.35) | 32 (51.61) | 30 (48.39) | 16 (38.10) | 12 (27.27) | 16 (38.10) | 18 (47.37) |
Short acting Insulin, n (%) | 40 (24.10) | 16 (40.00) | 24 (60.00) | 6 (14.29) | 11 (25.00) | 10 (23.81) | 13 (34.21) |
Mixtard, n (%) | 8 (4.82) | 5 (50.00) | 4 (50.00) | 2 (4.76) | 3 (6.82) | 2 (4.76) | 1 (2.63) |
Pioglitazone, n (%) | 2 (1.20) | 1 (50.00) | 1 (50.00) | 1 (2.38) | 1 (2.27) | 0 | 0 |
SGLT-inhibitors, n (%) | 13 (7.83) | 6 (46.15) | 7 (53.85) | 4 (9.52) | 3 (6.82) | 2 (4.76) | 4 (10.53) |
Medications: Hyperlipidaemia | |||||||
Statin, n (%) | 129 (77.71) | 62 (48.06) | 67 (51.94) | 32 (76.19) | 35 (79.55) | 30 (71.43) | 32 (84.21) |
Fibrate, n (%) | 17 (10.24) | 11 (64.71) | 6 (35.29) | 5 (11.90) | 2 (4.55) | 6 (14.29) | 4 (10.53) |
Ezetimibe, n (%) | 2 (1.20) | 1 (50.00) | 1 (50.00) | 0 | 1 (2.27) | 1 (2.38) | 0 |
Medications: Hypertension | |||||||
ACE-Inhibitor, n (%) | 51 (30.72) | 21 (41.18) | 30 (58.82) | 12 (28.57) | 15 (34.09) | 9 (21.43) | 15 (39.47) |
Angiotensin Receptor Blocker, n (%) | 57 (34.34) | 24 (42.11) | 33 (57.89) | 15 (35.71) | 16 (36.36) | 9 (21.43) | 15 (44.74) |
Beta blocker, n (%) | 31 (18.67) | 16 (51.61) | 15 (48.39) | 7 (16.67) | 8 (18.18) | 9 (21.43) | 7 (18.42) |
Calcium channel blocker, n (%) | 36 (21.69) | 17 (47.22) | 19 (52.78) | 8 (19.05) | 12 (27.27) | 9 (21.43) | 7 (18.42) |
Diuretics, n (%) | 11 (6.63) | 5 (45.45) | 6 (54.55) | 2 (4.76) | 2 (4.55) | 3 (7.14) | 4 (10.53) |
Aspirin, n (%) | 31 (18.67) | 11 (35.48) | 20 (64.52) | 8 (19.05) | 11 (25.00) | 3 (7.14) | 9 (23.68) |
Other antiplatelet, n (%) | 6 (3.61) | 3 (50.00) | 3 (50.00) | 3 (7.14) | 2 (4.55) | 0 | 1 (2.63) |
Total | Non-Hp2-2 | Hp2-2 | p value | |
|---|---|---|---|---|
(b) Baseline variables by Hp genotype | ||||
Number (%) | 166 | 80 (48.20) | 86 (51.80) | |
Age years, mean (SD) | 56 (10) | 55 (10) | 58 (10) | 0.071 |
Gender | ||||
Female, n (%) | 83 (50.00) | 36 (43.37) | 47 (56.63) | 0.214 |
Male, n (%) | 83 (50.00) | 44 (53.01) | 39 (46.99) | |
Ethnicity | ||||
Chinese, n (%) | 103 (62.05) | 60 (58.25) | 43 (41.75) | <0.001* |
Malay, n (%) | 24 (14.46) | 12 (50.00) | 12 (50.00) | |
Indian, n (%) | 39 (23.49) | 8 (20.51) | 31 (79.49) | |
Duration of DM years, mean (SD) | 12 (8) | 12 (9) | 11 (7) | 0.201 |
Duration of Hypertension years, mean (SD) | 8.5 (9) | 7 (8) | 10 (10) | 0.016* |
Duration of Hyperlipidaemia years, mean (SD) | 9 (9) | 11 (10) | 8 (7) | 0.033* |
Number of patients with known stable IHD, N(%) | 13 (7) | 6 (7.5) | 7 (8.1) | 0.878 |
Physical measurements | ||||
BMI Kg/m2, mean (SD) | 27.37 (4.94) | 26.94 (4.54) | 27.77 (5.29) | 0.282 |
Waist circumference cm, mean (SD) | 93.81 (10.55) | 93.67 (10.86) | 93.94 (10.33) | 0.871 |
Systolic BP (Peripheral) mmHg, mean (SD) | 134 (15) | 134 (16) | 134 (14) | 0.879 |
Diastolic BP (Peripheral) mmHg, mean (SD) | 76 (8) | 75 (8) | 76 (8) | 0.291 |
HbA1c %, mean (SD) | 7.92 (1.17) | 7.87 (0.95) | 7.98 (1.35) | 0.573 |
Lipid parameters | ||||
Total cholesterol mmol/L, mean (SD) | 4.20 (0.92) | 4.09 (0.94) | 4.30 (0.90) | 0.142 |
LDL cholesterol mmol/L, Median (IQR) | 2.3 (0.9) | 2.2 (0.7) | 2.4 (1.1) | 0.036* |
HDL cholesterol mmol/L, Median (IQR) | 1.1 (0.2) | 1.1 (0.3) | 1.1 (0.2) | 0.856 |
Triglycerides mmol/L, Median (IQR) | 1.3 (1.0) | 1.3 (1.0) | 1.3 (1.0) | 0.404 |
Creatinine μmol/L, mean (SD) | 75.02 (21.08) | 74.24 (20.73) | 75.82 (21.56) | 0.653 |
eGFR ml/min/1.73 m2, median (IQR) | 89.6 (25.6) | 88.7 (22.5) | 93.6 (26.5) | 0.248 |
Urine ACR mg/mmol, Median (IQR) | 1.6 (3.4) | 1.6 (3.70) | 1.5 (4.30) | 0.646 |
Haematological parameters | ||||
Haptoglobin mg/dL, mean (SD) | 116.12 (50.68) | 127.55 (49.09) | 105.49 (50.11) | 0.005* |
Ferritin μg/L, Median (IQR) | 72 (112) | 81 (119) | 65 (101) | 0.123 |
Transferrin g/L, mean (SD) | 2.48 (0.36) | 2.46 (0.34) | 2.51 (0.38) | 0.347 |
Fe Concentration μmol/L, mean (SD) | 13.67 (4.65) | 13.97 (3.83) | 13.40 (5.32) | 0.478 |
Haemoglobin g/dL, mean (SD) | 13.17 (1.42) | 13.33 (1.40) | 13.07 (1.44) | 0.438 |
Alpha-tocopherol concentration μg/ml, Median (IQR) | 38.67 (32.80) | 41.89 (33.07) | 31.98 (34.00) | 0.062 |
Vascular markers | ||||
hsCRP mg/L, Median (IQR) | 1.45 (3.1) | 1.05 (2.78) | 1.95 (3.45) | 0.088 |
Oxidative Stress index: dROMS, Median (IQR) | 271 (73) | 266 (62) | 278.5 (74) | 0.124 |
Oxidative Stress index: BAPs uM, Mean (SD) | 2218.12 (280.74) | 2220.47 (289.43) | 2234.33 (273.19) | 0.441 |
CIMT: Average of left and right mm, mean (SD) | 0.65 (0.13) | 0.66 (0.14) | 0.64 (0.12) | 0.4 |
CIMT: Maximum of left and right mm, mean (SD) | 0.793 (0.152) | 0.81 (0.17) | 0.78 (0.14) | 0.311 |
EndoPAT: Endothelial function - LnRHI, mean (SD) | 0.670 (0.250) | 0.67 (0.24) | 0.67 (0.26) | 0.926 |
EndoPAT: Augmentation index at 75bpm %, mean (SD) | 17.7 (15.0) | 17.6 (14.3) | 17.9 (15.8) | 0.908 |
Sphygmocor Systolic BP (Central) mmHg, mean (SD) | 121 (14) | 121 (14) | 122 (13) | 0.699 |
Sphygmocor Diastolic BP (Central) mmHg, mean (SD) | 79 (9) | 78 (10) | 80 (9) | 0.352 |
Sphygmocor Pulse Wave Velocity m/s, mean (SD) | 8.34 (1.74) | 8.40 (1.81) | 8.30 (1.69) | 0.69 |
SphygmoCor: Augmentation index %, mean (SD) | 29.7 (10.1) | 29.5 (9.1) | 30.0 (11.0) | 0.75 |
Oxidised LDL IU/L, Median (IQR) | 55.92 (21.65) | 56.71 (23.33) | 55.20 (20.08) | 0.655 |
