Table 1 Characterization of incident ESA users at baseline
Cancer patients N = 464 | CKD patients N = 616 | |
|---|---|---|
Sex – N (%) | ||
Males | 217 (46.8) | 356 (57.8) |
Females | 247 (53.2) | 260 (42.2) |
Age – yeara | 66.9 ± 12.2 | 72.6 ± 14.7 |
Age category – N (%) | ||
< 45 | 22 (4.7) | 38 (6.1) |
45–64 | 154 (33.2) | 126 (20.5) |
65–79 | 227 (48.9) | 234 (38.0) |
≥ 80 | 61 (13.2) | 218 (35.4) |
Baseline Hb - g/dLa | 9.7 ± 1.1 | 10.1 ± 1.1 |
Baseline Hb ≥11 g/dL - N (%) | 48 (10.3) | 114 (18.5) |
Days of ESA exposurea | 101.8 ± 40.5 | 119.4 ± 41.0 |
ESA dosage during the follow-upa | ||
IU | 34,994.1 ± 9308.1 | 8564.6 ± 4835.4 |
Mcg | 204.7 ± 132.1 | 49.9 ± 30.0 |
Catchment area –N (%) | ||
Caserta | 99 (21.3) | 80 (13.0) |
Treviso | 365 (78.7) | 536 (87.0) |
Type of ESA – N (%) | ||
Reference product | 129 (27.8) | 126 (20.5) |
Biosimilar | 209 (45.0) | 284 (46.1) |
Other ESAs covered by patent | 126 (27.2) | 206 (33.4) |
Hospitalizations/PS visits – N(%)b | ||
No | 203 (43.8) | 208 (33.8) |
Cardiovascular hosp. | 6 (1.3) | 44 (7.1) |
Non cardiovascular hosp. | 244 (52.6) | 283 (45.9) |
Both cardiovascular and non-cardiovascular hosp. | 11 (2.4) | 81 (13.1) |
Comorbidities – N (%)c | ||
Arrhythmia | 30 (6.5) | 139 (22.6) |
Ischemic heart disease | 23 (5.0) | 106 (17.2) |
Diabetes mellitus | 116 (25.0) | 258 (41.9) |
Heart failure | 28 (6.0) | 193 (31.3) |
Hypertension | 310 (66.8) | 574 (93.2) |
Dialysis | – | 90 (14.6) |
Stage of CKD – N(%) | ||
1 (GFR ≥ 90) | – | 2 (0.3) |
2 (90 > GFR ≥ 60) | – | 11 (1.8) |
3 (60 > GFR ≥ 30) | – | 188 (30.5) |
4 (30 > GFR ≥ 15) | – | 230 (37.3) |
5 and dialysis (GFR < 15 (or dialysis code)) | – | 180 (29.2) |
Not classified | 5 (0.8) | |
Type of tumor – N(%) | ||
Benign | 4 (0.9) | – |
Solid malignant | 161 (34.7) | – |
Non solid malignant | 72 (15.5) | – |
Both solid and non-solid malignant | 19 (4.1) | – |
Non classified | 208 (44.8) | – |
Concomitant drugs – N (%)d | ||
Iron preparations | 39 (8.4) | 113 (18.3) |
Vitamin B12 | 7 (1.5) | 12 (1.9) |
Folic acid | 37 (8.0) | 59 (9.6) |
ACE Inhibitors/ARBs | 143 (30.8) | 265 (43.0) |
Laboratory values | ||
Albumin (g/dL; normal range: 3.5–5.5)a | 3.6 ± 0.6 | 3.7 ± 0.6 |
Creatinine (mg/dL; normal range: M = 0.7–1.2; F = 0.6–1.2)e | 0.9 (0.7–1.1) | 2.5 (1.7–4.0) |
Potassium (mEq/L; normal range: 3.6–5.0)a | 4.4 ± 0.6 | 4.7 ± 0.7 |
Transferrin saturation (%)a | 20.7 ± 14.3 | 22.3 ± 14.1 |
Sideremia (mcg/dL; normal range: M = 75–160; F = 60–150)e | 56.0 (37.0–83.7) | 50.0 (33.0–71.0) |
Ferritin (mcg/L; normal range: M = 60–300; F = 30–150)e | 278.4 (112.0–583.6) | 150.6 (59.5–329.3) |
Parathyroid hormone (pg/ml; normal range: 10–60)e | 47.0 (27.0–79.0) | 160.0 (85.0–300.3) |
Vitamin B12 (ng/ml; normal range:300–900)a | 491.6 ± 224.3 | 506.9 ± 248.4 |
Folate (ng/ml; normal range: 2.7–17)e | 6.0 (3.9–8.8) | 5.2 (3.5–7.6) |
CRP (mg/dL; normal value: < 0.5)e | 0.9 (0.3–4.4) | 0.9 (0.3–3.1) |