Table 1.
Baseline characteristics of participants in EMPA-REG OUTCOME with and without HYPO-broad
| Participants with HYPO-broad |
Participants without HYPO-broad |
|||
|---|---|---|---|---|
| Empagliflozin (n = 1307) | Placebo (n = 657) | Empagliflozin (n = 3380) | Placebo (n = 1676) | |
| Age (years) | 63.5 (8.5) | 63.8 (8.3) | 63.0 (8.6) | 63.0 (9.0) |
| Male | 922 (70.5) | 462 (70.3) | 2414 (71.4) | 1218 (72.7) |
| eGFR, MDRD (mL/min/1.73 m2) | 71.7 (21.7) | 69.2 (20.7) | 75.1 (21.5) | 75.6 (20.9) |
| 30 to <60 | 391 (29.9) | 234 (35.6) | 800 (23.7) | 367 (21.9) |
| <30 | 6 (0.5) | 4 (0.6) | 15 (0.4) | 2 (0.1) |
| UACR (mg/g), median (IQR) | 21.2 (7.1–90.2) | 22.5 (8.0–109.2) | 16.8 (6.2–64.5) | 16.8 (6.2–62.8) |
| UACR (mg/g) | ||||
| <30 | 728 (55.7) | 357 (54.3) | 2061 (61.0) | 1025 (61.2) |
| 30–300 | 392 (30.0) | 198 (30.1) | 946 (28.0) | 477 (28.5) |
| >300 | 168 (12.9) | 97 (14.8) | 341 (10.1) | 163 (9.7) |
| Missing | 19 (1.5) | 5 (0.8) | 32 (0.9) | 11 (0.7) |
| HbA1c (%) | 8.1 (0.8) | 8.1 (0.8) | 8.1 (0.9) | 8.1 (0.9) |
| Diabetes duration (years) | ||||
| ≤1 | 9 (0.7) | 7 (1.1) | 119 (3.5) | 45 (2.7) |
| >1 to 5 | 84 (6.4) | 38 (5.8) | 628 (18.6) | 333 (19.9) |
| >5 to 10 | 254 (19.4) | 115 (17.5) | 921 (27.2) | 456 (27.2) |
| >10 | 960 (73.5) | 497 (75.6) | 1712 (50.7) | 842 (50.2) |
| BMI (kg/m2) | 30.7 (5.4) | 30.6 (5.0) | 30.6 (5.2) | 30.7 (5.3) |
| SBP/DBP (mmHg) | 137 (18)/75 (10) | 136 (19)/75 (11) | 135 (17)/77 (10) | 136 (17)/77 (10) |
| Background medications | ||||
| Insulin | 969 (74.1) | 483 (73.5) | 1283 (38.0) | 652 (38.9) |
| Daily insulin dose | 69.4 (49.7) | 71.2 (57.2) | 62.4 (47.2) | 60.3 (44.6) |
| Metformin | 929 (71.1) | 452 (68.8) | 2530 (74.9) | 1282 (76.5) |
| Sulfonylurea | 496 (37.9) | 232 (35.3) | 1518 (44.9) | 760 (45.3) |
| Any antihypertensives | 1249 (95.6) | 620 (94.4) | 3198 (94.6) | 1602 (95.6) |
| ACE inhibitor/ARB | 1087 (83.2) | 537 (81.7) | 2712 (80.2) | 1331 (79.4) |
| Statins | 1070 (81.9) | 532 (81.0) | 2560 (75.7) | 1241 (74.0) |
| Pre-existing conditions | ||||
| Prior stroke | 258 (19.7) | 138 (21.0) | 826 (24.4) | 415 (24.8) |
| Prior MI | 572 (43.8) | 291 (44.3) | 1618 (47.9) | 792 (47.3) |
| Heart failure | 116 (8.9) | 70 (10.7) | 346 (10.2) | 174 (10.4) |
| Retinopathy | 403 (30.8) | 221 (33.6) | 620 (18.3) | 302 (18.0) |
Data are expressed as n (%) and continuous parameters reported as mean (standard deviation) unless otherwise stated. Patients were treated with ≥1 dose of study drug; those with/without a hypoglycaemic AE were determined at the time of CV event/censoring (time at risk not considered).
ACE, angiotensin-converting enzyme; AE, adverse event; ARB, angiotensin-receptor blocker; BMI, body mass index; CV, cardiovascular; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; HbA1c, glycated haemoglobin; HYPO-broad, any symptomatic hypoglycaemic AE with PG ≤70 mg/dL, a hypoglycaemic AE with PG <54 mg/dL, or a severe hypoglycaemic AE (requiring assistance regardless of PG level); IQR, interquartile range; MDRD, modification of diet in renal disease; MI, myocardial infarction; PG, plasma glucose; SBP, systolic blood pressure; UACR, urine albumin-to-creatinine ratio.