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. 2023 Sep 20;64:102227. doi: 10.1016/j.eclinm.2023.102227

Table 3.

Serial changes in laboratory profiles and the proportion of patients with LDL-cholesterol level of <70 mg/dL according to diabetes mellitus and treatment strategy.

Patients with DM
Patients without DM
Treat-to-target group High-intensity statin group p-value Treat-to-target group High-intensity statin group p-value
At randomization
 Total number of patients 735 733 1465 1467
 LDL-cholesterol, mg/dL 78.4 (31.1) 78.8 (28.8) 0.76 90.4 (32.8) 91.2 (31.9) 0.50
 Total cholesterol, mg/dL 145.2 (36.3) 147.4 (33.4) 0.24 161.5 (37.9) 162.3 (37.8) 0.53
 Triglycerides, mg/dL 143.2 (90.1) 146.9 (87.9) 0.43 136.0 (79.8) 132.1 (79.8) 0.18
 HDL-cholesterol, mg/dL 44.4 (11.3) 44.4 (10.8) 0.98 47.9 (11.4) 48.2 (11.7) 0.44
 Number of patients with LDL cholesterol level <70 mg/dL 315 (42.9%) 298 (40.7%) 0.42 397 (27.1%) 357 (24.3%) 0.10
 Serum haemoglobin A1c level, % 7.2 (1.2) 7.1 (1.1) 0.11 5.9 (0.5) 5.9 (0.5) 0.86
At 1-year
 Total number of patients 629 633 1233 1221
 LDL-cholesterol, mg/dL 66.6 (20.3) 64.4 (22.1) 0.07 70.7 (20.6) 70.7 (22.7) 0.98
 Total cholesterol, mg/dL 135.9 (27.6) 138.4 (28.4) 0.11 137.7 (27.4) 135.9 (26.8) 0.10
 Triglycerides, mg/dL 135.2 (86.6) 133.8 (81.3) 0.78 130.3 (74.4) 128.8 (72.3) 0.58
 HDL-cholesterol, mg/dL 47.4 (11.9) 47.4 (11.8) 0.99 47.9 (11.8) 47.7 (11.9) 0.50
 Number of patients with LDL cholesterol level <70 mg/dL 395 (62.8%) 416 (65.7%) 0.31 643 (52.1%) 676 (55.4%) 0.12
 Serum haemoglobin A1c level, % 7.2 (1.2) 7.2 (1.2) 0.47 5.9 (0.5) 5.9 (0.6) 0.26
At 2 years
 Total number of patients 550 578 1104 1101
 LDL-cholesterol, mg/dL 63.1 (19.9) 63.0 (23.0) 0.94 68.6 (18.9) 69.2 (22.0) 0.47
 Total cholesterol, mg/dL 134.6 (26.8) 135.9 (27.5) 0.43 137.2 (26.1) 135.6 (26.0) 0.14
 Triglycerides, mg/dL 131.2 (80.1) 130.7 (75.4) 0.91 127.7 (67.4) 122.5 (69.0) 0.08
 HDL-cholesterol, mg/dL 47.0 (11.9) 46.6 (12.0) 0.53 47.9 (11.5) 47.3 (11.7) 0.24
 Number of patients with LDL cholesterol level <70 mg/dL 380 (69.1%) 386 (66.8%) 0.44 625 (56.6%) 629 (57.1%) 0.84
 Serum haemoglobin A1c level, % 7.2 (1.2) 7.2 (1.1) 0.69 5.9 (0.5) 6.0 (0.6) 0.36
At 3 years
 Total number of patients 532 555 1028 999
 LDL-cholesterol, mg/dL 63.6 (19.9) 62.9 (21.7) 0.54 69.6 (21.6) 70.1 (23.3) 0.63
 Total cholesterol, mg/dL 133.3 (26.9) 137.3 (28.7) 0.02 136.3 (26.6) 136.0 (26.2) 0.80
 Triglycerides, mg/dL 128.9 (71.5) 126.9 (84.7) 0.66 128.0 (73.9) 126.9 (79.5) 0.74
 HDL-cholesterol, mg/dL 45.7 (11.2) 46.9 (11.6) 0.09 46.7 (11.6) 47.1 (11.4) 0.41
 Number of patients with LDL cholesterol level <70 mg/dL 353 (66.4%) 378 (68.1%) 0.58 555 (54.0%) 549 (55.0%) 0.70
 Serum haemoglobin A1c level, % 7.2 (1.2) 7.1 (1.1) 0.11 6.0 (0.5) 6.0 (0.5) 0.86

Data are presented as means (standard deviations) or number (%). DM, diabetes mellitus; LDL, low-density lipoprotein; HDL, high-density lipoprotein.