Background
Methods
Trial design and patients
Measurements
Statistical analysis
Results
Baseline characteristics of patients
Overall cohort (N = 353) | Randomly extracted cohort (N = 100) | |||
---|---|---|---|---|
Anagliptin (n = 177) | Sitagliptin (n = 176) | Anagliptin (n = 50) | Sitagliptin (n = 50) | |
Age, year | 68 ± 10 | 68 ± 9 | 67 ± 8 | 68 ± 9 |
Female | 67 (38) | 72 (41) | 19 (38) | 18 (36) |
Body mass index, kg/m2 | 26.5 ± 4.0 | 25.9 ± 3.5 | 26.1 ± 3.5 | 24.7 ± 2.7 |
Systolic blood pressure, mm Hg | 134 ± 16 | 132 ± 16 | 130 ± 14 | 134 ± 19 |
Diastolic blood pressure, mm Hg | 74 ± 12 | 71 ± 11 | 70 ± 11 | 71 ± 10 |
Smoker | 92 (52) | 103 (59) | 26 (52) | 31 (62) |
Current smoker | 30 (17) | 24 (14) | 7 (14) | 8 (16) |
Past smoker | 62 (35) | 79 (45) | 19 (38) | 23 (46) |
Non-drinker | 102 (58) | 102 (58) | 35 (70) | 26 (52) |
Hypertension | 137 (77) | 133 (76) | 38 (76) | 36 (72) |
Coronary artery disease | 80 (45) | 79 (45) | 23 (46) | 19 (38) |
Stroke | 26 (15) | 26 (15) | 7 (14) | 5 (10) |
Treatment | ||||
Renin–angiotensin–aldosterone system inhibitor | 107 (60) | 99 (56) | 29 (58) | 27 (54) |
Strong statina | 142 (80) | 136 (77) | 37 (74) | 39 (78) |
Ezetimibe | 18 (10) | 12 (7) | 6 (12) | 1 (2) |
Metformin | 87 (49) | 84 (48) | 26 (52) | 18 (36) |
Sulfonylurea | 46 (26) | 37 (21) | 13 (26) | 10 (20) |
Thiazolidine | 25 (14) | 31 (18) | 9 (18) | 10 (20) |
Insulin | 13 (7) | 15 (9) | 4 (8) | 7 (14) |
Other glucose-lowering drugs | 27 (15) | 18 (10) | 9 (18) | 5 (10) |
Changes in markers of cholesterol absorption and synthesis
Changes in metabolic markers
Anagliptin (n = 177) | Sitagliptin (n = 176) | P valuea | |||||
---|---|---|---|---|---|---|---|
Baseline | 52 week | P value | Baseline | 52 week | P value | ||
Low-density lipoprotein cholesterol, mg/dL | 112 ± 22 | 108 ± 22 | 0.01 | 109 ± 22 | 111 ± 22 | 0.23 | 0.01 |
Total cholesterol, mg/dL | 191 ± 29 | 186 ± 27 | 0.03 | 186 ± 28 | 190 ± 28 | 0.02 | 0.001 |
Triglyceride, mg/dL | 148 ± 77 | 155 ± 84 | 0.42 | 129 ± 68 | 136 ± 82 | 0.19 | 0.80 |
Adiponectin, μg/mL | 4.4 ± 4.4 | 4.7 ± 5.2 | 0.01 | 4.7 ± 4.9 | 5.0 ± 5.8 | 0.14 | 0.23 |
Aspartate aminotransferase, IU/L | 28 ± 18 | 27 ± 18 | 0.60 | 23 ± 9 | 26 ± 19 | 0.02 | 0.05 |
Alanine aminotransferase, IU/L | 29 ± 19 | 28 ± 20 | 0.40 | 22 ± 13 | 23 ± 15 | 0.41 | 0.24 |
Platelets, 104/μL | 22 ± 6 | 21 ± 6 | 0.14 | 22 ± 5 | 22 ± 6 | 0.92 | 0.23 |
FIB-4 index | 1.8 ± 0.9 | 1.8 ± 0.9 | 0.36 | 1.7 ± 0.8 | 1.9 ± 1.3 | 0.03 | 0.19 |
Lipoprotein (a), mg/dLb | 11.2 ± 9.4 | 11.3 ± 9.1 | 0.81 | 14.0 ± 11.6 | 14.4 ± 12.3 | 0.39 | 0.65 |
Malondialdehyde-modified low-density lipoprotein, U/Lb | 162.9 ± 51.3 | 153.5 ± 50.9 | 0.05 | 152.3 ± 42.4 | 153.6 ± 45.6 | 0.80 | 0.13 |
Remnant-like particle cholesterol, mmol/Lb | 7.6 ± 4.9 | 8.8 ± 6.8 | 0.07 | 6.6 ± 4.5 | 7.7 ± 5.4 | 0.04 | 0.91 |