Risk and benefit considerations for use of HIF-PHIs in patients with CKD
| Potential benefits . | Potential disadvantages including theoretical risks . |
|---|---|
| Oral dosing for patients not on dialysis (indication not yet approved in United States), patients on home HD or peritoneal dialysis | In NDD-CKD cardiovascular safety trials, lack of non-inferiority compared to ESAs (dependent on type of analysis and geographical location) |
| No cold storage needed | Potential drug-drug interactions due to polypharmacy |
| Beneficial effects on iron metabolism (absorption and utilization) | Increased pill burden, potential for error due to different strength pills and overdosing, narrow therapeutic window |
| Effective in patients with chronic inflammationa | Difficult compliance monitoring |
| Potential cytoprotective effects | Risk of promoting malignancy or kidney cyst growth |
| Risk of promoting proliferative retinopathy | |
| Risk of promoting pulmonary arterial hypertension | |
| Lack of studies on use in children and patients post renal transplantation |
| Potential benefits . | Potential disadvantages including theoretical risks . |
|---|---|
| Oral dosing for patients not on dialysis (indication not yet approved in United States), patients on home HD or peritoneal dialysis | In NDD-CKD cardiovascular safety trials, lack of non-inferiority compared to ESAs (dependent on type of analysis and geographical location) |
| No cold storage needed | Potential drug-drug interactions due to polypharmacy |
| Beneficial effects on iron metabolism (absorption and utilization) | Increased pill burden, potential for error due to different strength pills and overdosing, narrow therapeutic window |
| Effective in patients with chronic inflammationa | Difficult compliance monitoring |
| Potential cytoprotective effects | Risk of promoting malignancy or kidney cyst growth |
| Risk of promoting proliferative retinopathy | |
| Risk of promoting pulmonary arterial hypertension | |
| Lack of studies on use in children and patients post renal transplantation |
It is unclear whether HIF-PHIs are more effective in patients with inflammation at the recommended dose levels; further studies are pending.
NDD, non–dialysis-dependent.