Background
Methods
Trial design and study population
Random assignment and follow-up
Events
Statistical analyses
Results
Baseline characteristics
Participants | Number of events per participant | P (trend) | |||
---|---|---|---|---|---|
0 | 1 | ≥ 2 | |||
Randomized | 9901 | 8233 | 1425 | 243 | |
Mean age (years) | 9901 | 65.8 (6.3) | 68.1 (7.3) | 67.9 (8.0) | < 0.0001 |
Female | 4589 | 3972 (48.2) | 522 (36.6) | 95 (39.1) | < 0.0001 |
White | 7498 | 6207 (75.4) | 1096 (76.9) | 195 (80.3) | 0.044 |
Tobacco consumption | 1407 | 1113 (13.5) | 254 (17.8) | 40 (16.5) | < 0.0001 |
Prior cardiovascular disease | 3114 | 2362 (28.7) | 614 (43.1) | 138 (56.8) | < 0.0001 |
Hypertension | 9224 | 7658 (93.0) | 1338 (93.9) | 228 (93.8) | 0.23 |
Prior heart failure | 853 | 626 (7.6) | 184 (12.9) | 43 (17.7) | < 0.0001 |
Mean diabetes duration (years) | 9901 | 10.3 (7.04) | 11.4 (7.91) | 11.8 (8.67) | < 0.0001 |
Mean BMI (kg/m2) | 9900 | 32.4 (5.7) | 32.0 (5.78) | 32.6 (6.12) | 0.16 |
Mean SBP (mm Hg) | 9901 | 137 (16.5) | 140 (18.0) | 139 (17.7) | < 0.0001 |
Mean DBP (mm Hg) | 9901 | 78.5 (9.7) | 78.6 (10.3) | 77.2 (10.6) | 0.463 |
Mean HbA1c | 9876 | 7.3 (1.0) | 7.4 (1.1) | 7.4 (1.0) | 0.0062 |
Mean eGFR (mL/min per 1.73 m2) | 9640 | 77.9 (22.3) | 71.7 (24.0) | 70.7 (23.8) | < 0.0001 |
Mean LDL (mmol/L) | 9590 | 2.55 (0.97) | 2.64 (1.00) | 2.48 (0.96) | 0.092 |
Medications | |||||
Metformin | 8037 | 6737 (81.8) | 1111 (78.0) | 189 (77.8) | 0.0004 |
Sulfonylurea | 4552 | 3740 (45.4) | 700 (49.1) | 112 (46.1) | 0.0430 |
Insulin | 2363 | 1889 (22.9) | 409 (28.7) | 65 (26.8) | < 0.0001 |
DPP4i | 564 | 484 (5.9) | 64 (4.5) | 16 (6.6) | 0.220 |
Thiazolidinedione | 168 | 150 (1.8) | 14 (1.0) | 4 (1.7) | 0.073 |
Other glucose lowering drugs | 32 | 28 (0.3) | 4 (0.3) | 0 | 0.39 |
ACEI/ARB | 8068 | 6700 (81.4) | 1166 (81.8) | 202 (83.1) | 0.47 |
Beta blocker | 4512 | 3628 (44.1) | 737 (51.7) | 147 (60.5) | < 0.0001 |
Other BP drug | 5599 | 4568 (55.5) | 871 (61.1) | 160 (65.8) | < 0.0001 |
Statin | 6547 | 5450 (66.2) | 907 (63.7) | 190 (78.2) | 0.27 |
Fibrate | 898 | 756 (9.2) | 119 (8.4) | 23 (9.5) | 0.52 |
Antiplatelet | 5342 | 4365 (53.0) | 812 (57.0) | 165 (67.9) | < 0.0001 |
Events during follow-up
Composite event | Dulaglutide group | Placebo group | Events avoideda | Conditional time gap model | Proportional means model | ||
---|---|---|---|---|---|---|---|
N (/1000py) | N (/1000py) | N (N/1000py) | HR (95% CI) | p | HR (95% CI) | P | |
MACE or non-CV death | 932 (35.8) | 1040 (40.3) | 108 (4.5) | 0.90 (0.82–0.98) | 0.020 | 0.89 (0.80–0.98) | 0.022 |
MACE, UA or non-CV death | 1034 (39.7) | 1123 (43.5) | 89 (3.8) | 0.92 (0.85–1.00) | 0.052 | 0.91 (0.83–1.01) | 0.066 |
MACE, HF or non-CV death | 1195 (45.9) | 1372 (53.2) | 177 (7.3) | 0.91 (0.84–0.99) | 0.021 | 0.86 (0.78–0.96) | 0.006 |
MACE, Revasc or non-CV death | 1399 (53.8) | 1519 (58.9) | 120 (5.1) | 0.92 (0.86–0.99) | 0.030 | 0.91 (0.83–1.01) | 0.0632 |
MACE, UA, HF, Revasc or non-CV death | 1747 (67.1) | 1926 (74.7) | 179 (7.6) | 0.93 (0.87–0.99) | 0.023 | 0.90 (0.82–0.99) | 0.028 |
Composite event | Dulaglutide group | Placebo group | People spareda | Cox model | |
---|---|---|---|---|---|
N (N/1000py) | N (N/1000py) | N (N/1000py) | HR (95% CI) | p | |
MACE or non-CV death | 789 (31.2) | 879 (35.3) | 90 (4.1) | 0.88 (0.80, 0.97) | 0.011 |
MACE, UA, or non-CV death | 859 (34.3) | 933 (37.8) | 74 (3.5) | 0.91 (0.83, 0.99) | 0.041 |
MACE, HF or non-CV death | 880 (35.3) | 983 (40.1) | 103 (4.8) | 0.88 (0.80, 0.96) | 0.0054 |
MACE, Revasc, or non-CV death | 1002 (40.8) | 1090 (44.9) | 88 (4.1) | 0.91 (0.83, 0.99) | 0.028 |
MACE, UA, HF, Revasc, or non-CV death | 1097 (45.3) | 1189 (49.8) | 92 (4.5) | 0.91 (0.84, 0.99) | 0.024 |