Table 1.
Clinical characteristics of study patients
| Avail (%) | Before IPTW | After IPTW | |||||||
|---|---|---|---|---|---|---|---|---|---|
| DPP4i N = 977 |
Dapagliflozin N = 445 | SMD | p | DPP4i N = 977 |
Dapagliflozin N = 445 | SMD | p | ||
| Year visit | 100% | 2016 (2015—2017) | 2017 (2016—2017) | 0.24 | < .0001 | 2016 (2016—2017) | 2016 (2016—2017) | 0.03 | 0.50 |
| Age, years | 100% | 74.7 ± 3.1 | 73.1 ± 2.7 | 0.54 | < .0001 | 74.2 ± 3.7 | 74.1 ± 5.5 | 0.03 | 0.41 |
| Sex male, n (%) | 100% | 523 (53.5%) | 236 (53.0%) | 0.01 | 0.86 | 532 (54.5%) | 252 (56.5%) | 0.04 | 0.36 |
| Diabetes duration, years | 100% | 12 (7—18) | 16 (10—21) | 0.30 | < .0001 | 13 (8—18) | 12 (7—19) | 0.01 | 0.75 |
| Weight, kg | 89% | 75.5 ± 14.2 | 86.1 ± 15.5 | 0.72 | < .0001 | 77.9 ± 18.3 | 79.7 ± 25.0 | 0.08 | 0.03 |
| BMI, kg/m2 | 87% | 28.1 ± 4.6 | 31.7 ± 5.4 | 0.73 | < .0001 | 28.9 ± 5.9 | 29.4 ± 8.5 | 0.08 | 0.05 |
| SBP, mm Hg | 72% | 139.5 ± 19.0 | 144.6 ± 20.3 | 0.26 | < .0001 | 140.7 ± 22.9 | 139.7 ± 32.5 | 0.03 | 0.38 |
| DBP, mm Hg | 72% | 76.8 ± 8.8 | 77.7 ± 10.3 | 0.10 | < .0001 | 76.9 ± 10.7 | 76.8 ± 16.7 | 0.01 | 0.80 |
| FPG, mg/dl | 89% | 156.3 ± 38.6 | 180.0 ± 58.6 | 0.48 | < .0001 | 164.4 ± 57.7 | 163.5 ± 83.3 | 0.01 | 0.74 |
| HbA1c, % | 100% | 8.0 ± 0.8 | 8.9 ± 1.2 | 0.83 | < .0001 | 8.3 ± 1.4 | 8.3 ± 1.9 | 0.01 | 0.81 |
| Target HbA1c, (%) | 100% | 7.1 ± 0.4 | 7.3 ± 0.4 | 0.74 | < .0001 | 7.1 ± 0.4 | 7.1 ± 0.7 | 0.02 | 0.67 |
| At target, n (%) | 100% | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | ||||
| Total cholesterol, mg/dl | 73% | 166.3 ± 35.6 | 169.7 ± 34.4 | 0.10 | 0.15 | 167.1 ± 44.4 | 165.3 ± 60.5 | 0.03 | 0.40 |
| HDL cholesterol, mg/dl | 70% | 51.1 ± 13.5 | 48.7 ± 13.4 | 0.18 | 0.01 | 50.4 ± 16.3 | 50.4 ± 25.4 | 0.00 | 0.97 |
| Triglycerides, mg/dl | 72% | 113 (83—153) | 127 (94—185) | 0.33 | < .0001 | 117 (85—161) | 119 (83—159) | 0.01 | 0.84 |
| LDL cholesterol, mg/dl | 69% | 90.0 ± 30.2 | 91.2 ± 28.7 | 0.04 | 0.57 | 90.8 ± 36.8 | 87.4 ± 48.4 | 0.08 | 0.12 |
| eGFR, ml/min/1.73 m2 | 100% | 79.1 ± 10.3 | 80.2 ± 10.2 | 0.11 | 0.06 | 79.8 ± 12.4 | 80.1 ± 17.5 | 0.02 | 0.58 |
| Complications | |||||||||
| CKD III stage, n (%) | 100% | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | ||||
| Nephropathy, n (%) | 100% | 114 (11.7%) | 84 (18.9%) | 0.20 | 0.0003 | 131 (13.4%) | 60 (13.5%) | 0.00 | 0.94 |
| Retinopathy, n (%) | 81% | 83 (10.5%) | 85 (23.2%) | 0.34 | < .0001 | 100 (10.2%) | 53 (11.9%) | 0.05 | 0.19 |
| DME, n (%) | 81% | 8 (1.0%) | 20 (5.4%) | 0.25 | < .0001 | 15 (1.5%) | 9 (2.0%) | 0.04 | 0.36 |
| Carotid ather., n (%) | 58% | 213 (37.6%) | 94 (37.3%) | 0.01 | 0.93 | 260 (26.6%) | 115 (25.9%) | 0.02 | 0.71 |
| Stroke/TIA, n (%) | 58% | 51 (9.0%) | 23 (9.1%) | 0.00 | 0.96 | 56 (5.7%) | 21 (4.8%) | 0.04 | 0.28 |
| Prior MI, n (%) | 86% | 42 (5.1%) | 20 (5.1%) | 0.00 | 1.00 | 48 (4.9%) | 19 (4.3%) | 0.03 | 0.54 |
| Coronary Revasc., n (%) | 86% | 64 (7.8%) | 33 (8.4%) | 0.02 | 0.70 | 68 (7.0%) | 25 (5.6%) | 0.06 | 0.17 |
| CHD, n (%) | 86% | 95 (11.5%) | 46 (11.7%) | 0.01 | 0.92 | 105 (10.7%) | 39 (8.8%) | 0.06 | 0.15 |
| Heart failure, n (%) | 86% | 15 (1.8%) | 13 (3.3%) | 0.09 | 0.10 | 22 (2.2%) | 13 (3.0%) | 0.05 | 0.33 |
| LVH, n (%) | 86% | 76 (9.2%) | 52 (13.2%) | 0.13 | 0.03 | 93 (9.6%) | 41 (9.2%) | 0.01 | 0.79 |
| Microangiopathy, n (%) | 100% | 276 (28.2%) | 189 (42.5%) | 0.30 | < .0001 | 300 (30.7%) | 142 (31.9%) | 0.02 | 0.53 |
| Macroangiopathy, n (%) | 89% | 324 (37.5%) | 150 (37.5%) | 0.00 | 0.99 | 352 (36.0%) | 149 (33.5%) | 0.05 | 0.23 |
| Established CVD, n (%) | 89% | 161 (18.7%) | 74 (18.5%) | 0.00 | 0.95 | 168 (17.2%) | 64 (14.4%) | 0.08 | 0.07 |
| Diabetes medicationsa | |||||||||
| Insulin, n (%) | 100% | 250 (25.6%) | 285 (64.0%) | 0.84 | < .0001 | 353 (36.2%) | 165 (37.1%) | 0.02 | 0.64 |
| Metformin, n (%) | 100% | 938 (96.0%) | 382 (85.8%) | 0.36 | < .0001 | 922 (94.4%) | 414 (93.0%) | 0.06 | 0.14 |
| Prev. line of treatmentb | 74% | 1.7 ± 0.8 | 2.1 ± 1.2 | 0.36 | < .0001 | 1.8 ± 1.1 | 1.8 ± 2.0 | 0.00 | 0.86 |
| Statin, n (%) | 100% | 572 (58.5%) | 267 (60.0%) | 0.03 | 0.61 | 554 (56.7%) | 255 (57.3%) | 0.01 | 0.83 |
| ACEi/ARB, n (%) | 100% | 573 (58.6%) | 303 (68.1%) | 0.20 | 0.22 | 579 (59.3%) | 282 (63.4%) | 0.09 | 0.04 |
| CCB, n (%) | 100% | 217 (22.2%) | 112 (25.2%) | 0.07 | 0.33 | 219 (22.4%) | 84 (18.9%) | 0.09 | 0.03 |
| Beta-blockers, n (%) | 100% | 279 (28.6%) | 116 (26.1%) | 0.06 | 0.80 | 256 (26.3%) | 110 (24.7%) | 0.04 | 0.41 |
| Diuretics, n (%) | 100% | 336 (34.4%) | 150 (33.7%) | 0.01 | 0.16 | 328 (33.5%) | 134 (30.0%) | 0.08 | 0.07 |
| APT, n (%) | 100% | 442 (45.2%) | 219 (49.2%) | 0.08 | 0.74 | 442 (45.2%) | 221 (49.6%) | 0.09 | 0.03 |
Variables in the two groups are compared before and after inverse probability of treatment weighting (IPTW). P values and standardized mean differences (SMD) are shown and only observed data are presented for the intention-to-treat dataset
BMI body mass index, SBP systolic blood pressure, DBP diastolic blood pressure, FPG fasting plasma glucose, HDL high-density lipoprotein, eGFR estimated glomerular filtration rate, DME Diabetic Macular oEdema, MI myocardial infarction, CHD coronary heart disease, CKD chronic kidney disease, TIA transient ischemic attack, LVH left-ventricular hypertrophy, ACEi angiotensin-converting enzyme inhibitors, ARBs angiotensin receptor blockers, CCB calcium channel blockers, APT anti-platelet therapies, GLM glucose-lowering medications
aThe combination of SGLT-2 inhibitors was reimbursed only with concomitant metformin and/or insulin treatment
bNumber of classes of anti-diabetic drugs used by the patients before the initiation of DPP4i or dapagliflozin