Table 2.
Characteristics of participants for SGLT‐2i cardiovascular outcomes trials and people in the RCGP RSC population that met inclusion criteria for each trial
| Characteristic* | CANVAS Program (canagliflozin) | DECLARE‐TIMI 58 (dapagliflozin) | EMPA‐REG OUTCOME (empagliflozin) | VERTIS CV (ertugliflozin) | ||||
|---|---|---|---|---|---|---|---|---|
|
CANVAS participants† (N = 5795) |
RCGP RSC – CANVAS inclusion criteria (N = 14 227) |
DECLARE participants‡ (N = 8582) |
RCGP RSC ‐ DECLARE inclusion criteria (N = 22 651) |
EMPA‐REG participants§ (N = 4687) |
RCGP RSC ‐ EMPA‐REG inclusion criteria (N = 5628) |
RCGP RSC ‐ VERTIS inclusion criteria (N = 6119) |
||
| Age (years) | 63.2 ± 8.3 | 69.9 ± 10.7 | 63.9 ± 6.8 | 69.3 ± 8.8 | 63.1 ± 8.6 | 71.8 ± 10.5 | 71.8 ± 10.5 | |
| Men | 3759 (64.9) | 9298 (65.4) | 5411 (63.1) | 14 162 (62.5) | 3336 (71.2) | 3950 (70.2) | 4311 (70.5) | |
| HbA1c | % | 8.2 ± 0.9 | 8.1 ± 0.9 | 8.3 ± 1.2 | 7.7 ± 1.3 | 8.1 ± 0.9 | 7.9 ± 0.8 | 8.0 ± 0.9 |
| mmol/mol | 66 ± 10 | 65 ± 10 | 67 ± 13 | 61 ± 14 | 65 ± 9 | 63 ± 8 | 64 ± 10 | |
| BMI (kg/m2) | 31.9 ± 5.9 | 31.1 ± 6.1 | 32.1 ± 6.0 | 31.1 ± 6.2 | 30.6 ± 5.3 | 30.3 ± 5.3 | 30.7 ± 5.9 | |
| SBP (mmHg) | 136.4 ± 15.8 | 134.5 ± 15.4 | 135.1 ± 15.3 | 133.5 ± 14.1 | 135.3 ± 16.9 | 131.7 ± 15.2 | 131.9 ± 15.5 | |
| DBP (mmHg) | 77.6 ± 9.6 | 74.0 ± 9.6 | NR | 74.5 ± 9.1 | 76.6 ± 9.7 | 72.4 ± 9.5 | 72.2 ± 9.7 | |
| Hypertension¶ | 5188 (89.5) | 10 705 (75.2) | 6977 (81.3) | 18 525 (81.8) | 4446 (94.9) | 4046 (71.9) | 4438 (72.5) | |
| eGFR (ml min−1 1.73 m−2) | 76.7 ± 20.3 | 76.0 ± 21.0 | 85.4 ± 15.8 | 83.8 ± 12.7 | 74.2 ± 21.6 | 72.7 ± 20.8 | 70.5 ± 23.0 | |
| Ethnicity | ||||||||
| White | 4508 (77.8) | 10 222 (71.8) | 6843 (79.7) | 16 152 (71.3) | 3403 (72.6) | 4142 (73.6) | 4491 (73.4) | |
| Non‐white‖ | 1287 (22.2) | 1896 (13.3) | 1739 (20.3) | 3095 (13.7) | 1284 (27.4)** | 609 (10.8) | 679 (11.1) | |
| Missing | – | 2109 (14.8) | – | 3404 (15.0) | – | 877 (15.6) | 949 (15.5) | |
| Duration of diabetes (years) | ||||||||
| Mean duration | 13.5 ± 7.7 | 13.5 ± 7.5 | NR | 10.4 ± 7.1 | NR | 13.0 ± 8.2 | 13.3 ± 8.4 | |
| Median duration (IQR) | NR | 12.9 (8.8–17.1) | 11.0 (6.0–16.0) | 9.7 (5.1–14.4) | NR | 12.1 (7.1–16.9) | 12.4 (7.3–17.5) | |
CVD, cardiovascular disease; NR, not reported.
Unless specified, data are mean ± sd or n (%).
Pooled canagliflozin participants (100 and 300 mg doses) in CANVAS or CANVAS‐R trials.
Dapagliflozin participants (10 mg doses).
Pooled empagliflozin participants (10 and 25 mg doses).
Previous hypertension or on antihypertensive therapy.
Trial data includes Asian, black and other ethnicity; RCGP RSC includes Asian, black, mixed ethnicity, and other ethnicity.
EMPA‐REG trial included 41 participants categorised as ‘other/missing’ ethnicity.