Abstract: TH-PO899
Real-World Evidence of Vadadustat in Patients with Anemia and CKD: Interim Results from Postmarketing Surveillance (VIOLET Survey) in Japan
Session Information
- Anemia and Iron Metabolism
October 24, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Ueta, Kiichiro, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
- Nishimura, Kenichi, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
- Sasaki, Kazuyo, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
- Bi, Jing, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
- Hashimoto, Takafumi, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
- Seto, Yuki, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan
- Nangaku, Masaomi, The University of Tokyo, Tokyo, Japan
Background
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. We report the interim results of ongoing post-marketing surveillance (PMS) in Japanese patients with anemia in CKD receiving vadadustat.
Methods
This 2-year, prospective, observational, multicenter PMS evaluated the safety and effectiveness of vadadustat in clinical practice. Patients with anemia in CKD who had not been treated with vadadustat were enrolled. The occurrence of adverse drug reactions (ADRs) and hemoglobin levels, etc., were evaluated for the interim analysis up to June 2023. ADRs of special interest included hepatic impairment, thromboembolism, hypertension, cardiovascular events excluding thromboembolism, malignant tumor, retinal hemorrhage, and progression of autosomal dominant polycystic kidney disease.
Results
A total of 1847 patients (non-dialysis (ND): 1233; peritoneal dialysis (PD): 142; hemodialysis (HD): 472) were included in safety analysis. The proportion of patients switched from erythropoiesis-stimulating agents was ND: 12.08%, PD: 33.80% and HD: 42.16%, respectively. The median duration for vadadustat treatment was ND: 182 days, PD: 182 and HD: 138 days. ADRs and serious ADRs occurred in 10.94% and 3.41% (overall), 10.30% and 2.92% (ND), 12.68% and 5.63% (PD) and 12.08% and 4.03% (HD), respectively. The most common ADR were ND: diarrhea (0.89%), PD: diarrhea (2.11%) and decreased appetite (2.11%), and HD: nausea (2.54%), respectively. There were no ADRs of special interest with incidence > 2%. The hemoglobin values (g/dL, mean ±SD [n]) at baseline and 1 year after the treatment were 10.10±1.16 [1198] and 11.23±1.39 [434] (ND), 10.57±1.32 [142] and 11.17±1.36 [40] (PD), and 10.10±1.38 [471] and 10.83±1.30 [109] (HD), respectively. The mean dose of vadadustat (mg/day) 1 year after the treatment were 321.7 (ND), 373.1 (PD) and 386.9 (HD). The latest interim results up to June 2024 will be presented at Kidney Week 2024.
Conclusion
Any new safety concerns beyond those already described in the package inserts were not identified in the interim analysis of PMS.
Funding
- Commercial Support – Mitsubishi Tanabe Pharma Corporation