Kidney Week

Abstract: PUB078

Safety and Efficacy of Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitors Compared with Erythropoiesis-Stimulating Agents in Patients with Nondialysis-Dependent CKD: Analysis of Real-World Data

Session Information

• Publication Only

Category: Anemia and Iron Metabolism

• 200 Anemia and Iron Metabolism

Authors

• Yamanouchi, Masayuki, Toranomon Hospital, Minato-ku, Tokyo, Japan

Masayuki Yamanouchi, MD, PhD, MPH

• Suwabe, Tatsuya, Toranomon Hospital, Minato-ku, Tokyo, Japan

Tatsuya Suwabe, MD, MS, PhD

• Furuichi, Kengo, Kanazawa Medical University, Kahoku-gun, Ishikawa, Japan

Kengo Furuichi, MD, PhD

• Wada, Takashi, Kanazawa University, Kanazawa, Ishikawa, Japan

Takashi Wada, MD, PhD

Background

Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors (HIF-PHIs) are expected to be an alternative to erythropoietin stimulating agents (ESAs) due to their ease of administration. However, evidence for the safety and efficacy of HIF-PHIs compared to ESAs is limited in the real-world clinical settings.

Methods

We emulated a target trial, using a 1:1 propensity score matching, to compare the safety and efficacy of outcomes in patients with non-dialysis dependent chronic kidney disease and renal anemia who initiated HIF-PHIs with those initiated ESAs. The primary safety outcomes were the first occurrence of MACE; composite of cardiovascular death, myocardial infarction, or stroke, expanded MACE; MACE plus hospitalization for either heart failure or a thromboembolic event, MAKE; composite of initiating kidney replacement therapy, experiencing over a 40 % eGFR decline from baseline, and all-cause mortality. The primary efficacy outcome was the mean changes in Hb level from baseline to month 21 through 24 (non-inferiority margin, -0.75 g/dL).

Results

During a median follow-up of 14 (IQR, 10-24) months, compared with patients initiating ESAs (n = 269), those initiating HIF-PHIs (n = 263) had a similar risk of MACE (Hazard ratio (HR) 0.80; [95% confidence interval (CI), 0.31-2.10]), expanded MACE (HR 0.81 [0.40-1.63]), MAKE (HR 1.01 [0.72-1.42]), and all-cause mortality (HR 1.41 [0.50-3.99]). The mean (±SE) changes in Hb level from baseline to month 21 through 24 were 1.62±0.16 g/dL in the HIF-PHIs group and 1.38±0.08 g/dL in the ESAs group.

Conclusion

There were no statistically significant differences in safety and efficacy between HIF-PHIs and ESAs. The results may help guide the choice of treatment of renal anemia.