Table 1.
Patient baseline characteristics in the safety analysis population (first age category analysis) of STELLA-LONG TERM and in STELLA-ELDER
| STELLA-LONG TERM | STELLA-ELDER [9] | |||
|---|---|---|---|---|
| < 65 years | ≥ 65 years | P valuea | ||
| All, n | 7894 | 3157 | 8505 | |
| Sex, n (%) | ||||
| Male | 5023 (63.6) | 1690 (53.5) | (1) < 0.001 | 4181 (49.2) |
| Female | 2871 (36.4) | 1467 (46.5) | 4324 (50.8) | |
| Age, years | ||||
| Mean ± SD | 51.2 ± 9.0 | 71.3 ± 5.5 | 72.3 ± 5.9 | |
| Median (range) | 52.0 (14–64) | 70.0 (65–95) | ||
| 65 to < 75, n (%) | – | 2405 (76.2) | 5800 (68.2) | |
| ≥ 75, n (%) | – | 752 (23.8) | 2705 (31.8) | |
| Body weight, kg, mean ± SD (n) | 81.92 ± 17.35 (6015) | 67.57 ± 12.01 (2157) | (2) < 0.001 | 67.5 ± 12.9 |
| BMI, kg/m2 | ||||
| Mean ± SD (n) | 29.90 ± 5.44 (5548) | 26.76 ± 4.07 (1944) | (2) < 0.001 | 27.0 ± 4.56 |
| < 25.0, n (%) | 883 (11.2) | 690 (21.9) | (1) < 0.001 | 1762 (20.7) |
| ≥ 25.0, n (%) | 4665 (59.1) | 1254 (39.7) | 3306 (38.9) | |
| Unknown | 2346 (29.7) | 1213 (38.4) | 3437 (40.4) | |
| Duration of diabetes, years | ||||
| Mean ± SD (n) | 7.22 ± 5.74 (5417) | 10.16 ± 7.79 (1831) | (2) < 0.001 | 10.6 ± 7.52 |
| < 5, n (%) | 2124 (26.9) | 469 (14.9) | (1) < 0.001 | 1177 (13.8) |
| ≥ 5, n (%) | 3293 (41.7) | 1362 (43.1) | 4150 (48.8) | |
| Unknown, n (%) | 2477 (31.4) | 1326 (42.0) | 3178 (37.4) | |
| Complications, n (%) | ||||
| Yes | 6603 (83.6) | 2762 (87.5) | (1) < 0.001 | 6917 (81.3) |
| No | 1232 (15.6) | 367 (11.6) | 1477 (17.4) | |
| Unknown | 59 (0.7) | 28 (0.9) | 111 (1.3) | |
| eGFR, mean mL/min/1.73 m2 ± SD (n) | 85.56 ± 19.35 (4762) | 70.56 ± 17.96 (1935) | (2) < 0.001 | 69.7 ± 19.4 |
| HbA1c, % | ||||
| Mean ± SD (n)b | 8.17 ± 1.51 (6413) | 7.77 ± 1.24 (2313) | (2) < 0.001 | 7.84 ± 1.33 (6853) |
| < 8%, n (%) | 3958 (50.1) | 1877 (59.5) | (1) < 0.001 | 4381 (51.5) |
| ≥ 8%, n (%) | 3473 (44.0) | 1009 (32.0) | 2747 (32.3) | |
| Unknown | 463 (5.9) | 271 (8.6) | 1377 (16.2) | |
| Initial dose of ipragliflozin, n (%) | ||||
| 25 mg | 879 (11.1) | 541 (17.1) | –c | 1152 (13.5) |
| 50 mg | 6999 (88.7) | 2613 (82.8) | 7344 (86.3) | |
| 100 mg | 13 (0.2) | 2 (0.1) | 9 (0.1) | |
| Other | 3 (0.04) | 1 (0.03) | 0 | |
| Daily dose of ipragliflozin, mg, mean ± SD (n) | 48.34 ± 8.39 (7894) | 46.73 ± 9.91 (3157) | (2) < 0.001 | |
| Dose changes during treatment, n (%) | ||||
| 25 mg to 25 mg | 602 (7.6) | 419 (13.3) | (1) < 0.001 | 856 (10.1) |
| 25 mg to 50 mg | 242 (3.1) | 102 (3.2) | 263 (3.1) | |
| 50 mg to 50 mg | 6765 (85.7) | 2514 (79.6) | 7168 (84.3) | |
| 50 mg to 100 mg | 121 (1.5) | 41 (1.3) | 78 (0.9) | |
| Other | 164 (2.1) | 81 (2.6) | 140 (1.6) | |
BMI body mass index, eGFR estimated glomerular filtration rate, HbA1c glycated hemoglobin, SD standard deviation
aP values across subgroups assessed by (1) chi-squared test or (2) two-sample t test; no statistical comparison between groups was made for specific complications
bMean HbA1c values were from the effectiveness analysis set
cNo P value was calculated when at least one element of the contingency table was < 10