Table 2.
Frequency distribution of safety outcomes by ESA exposure status
| Originator | Biosimilar | Unadjusted HR 95% CI | Adjusted HRa 95% CI | |
|---|---|---|---|---|
| Person-months | 3295 | 3668 | ||
| Any outcomes | 123 | 151 | 1.1 (0.9–1.4) | 1.0 (0.7–1.3) |
| Infections | 42 | 58 | 1.3 (0.9–1.9) | 0.9 (0.6–1.5) |
| Other infections | 18 | 30 | 1.5 (0.8–2.7) | 1.3 (0.7–2.4) |
| Respiratory infections | 15 | 17 | 1.0 (0.5–2.1) | 1.0 (0.5–2.1) |
| Sepsis | 9 | 11 | 1.1 (0.5–2.7) | 0.9 (0.3–2.2) |
| Cardio and cerebrovascular events | 42 | 50 | 1.1 (0.7–1.6) | 0.9 (0.6–1.5) |
| Bleeding | 15 | 13 | 0.8 (0.4–1.6) | 0.9 (0.4–2.0) |
| Arrhythmia | 3 | 12 | 3.2 (0.9–11.3) | 3.2 (0.9–11.3) |
| Peripheral ischemia | 6 | 9 | 1.4 (0.5–3.9) | 0.9 (0.3–2.5) |
| Cerebral accident | 6 | 6 | 0.9 (0.3–2.7) | 0.6 (0.2–2.0) |
| Coronary disease | 6 | 4 | 0.6 (0.2–2.1) | 0.7 (0.2–2.9) |
| Thrombosis | 6 | 3 | 0.4 (0.1–1.8) | 0.7 (0.2–3.2) |
| Heart failure | 0 | 3 | ||
| Problems related to dialysis device | 39 | 46 | 1.1 (0.7–1.7) | 1.1 (0.7–1.8) |
| Vascular complications of the fistula | 26 | 34 | 1.2 (0.7–2.0) | 1.1 (0.6–2.1) |
| Localized infections | 8 | 6 | 0.7 (0.2–2.0) | 0.6 (0.2–1.8) |
| Vascular complications of the catheter | 5 | 6 | 1.1 (0.3–3.6) | 1.5 (0.4–5.4) |
CI confidence interval, ESA erythropoiesis-stimulating agents, Hb hemoglobin, HR hazard ratio
aHRs were adjusted for age, vascular access, vascular disease, cerebrovascular disease, heart failure, diabetes, diabetic and hypertensive nephropathy, glomerulonephritis and epoetin dosage at the study start. Hb levels at baseline were not included in the final model since no difference in the two cohorts of users was observed