PMID- 35312234
OWN - NLM
STAT- MEDLINE
DCOM- 20221115
LR  - 20221229
IS  - 1744-9987 (Electronic)
IS  - 1744-9979 (Print)
IS  - 1744-9979 (Linking)
VI  - 26
IP  - 6
DP  - 2022 Dec
TI  - Safety of daprodustat in patients with anemia of chronic kidney disease: A pooled 
      analysis of phase 3 studies in Japan.
PG  - 1065-1078
LID - 10.1111/1744-9987.13839 [doi]
AB  - INTRODUCTION: Daprodustat is an approved treatment for anemia of chronic kidney 
      disease (CKD) in Japan. METHODS: This post hoc analysis evaluated pooled safety 
      data for daprodustat from 3 phase 3 Japanese studies in dialysis-dependent and 
      nondialysis patients with anemia of CKD. RESULTS: Median drug exposure duration 
      was 365 days for both daprodustat (N = 369) and injectable 
      erythropoiesis-stimulating agent (ESA, N = 285). The incidence per 100 
      patient-years of on-therapy adverse events (AEs) was 363.1 and 306.4 in the 
      daprodustat and ESA groups, respectively. The incidence per 100 patient-years of 
      thromboembolic and retinal events were 5.55 and 6.91 (daprodustat) and 6.28 and 
      7.46 (ESA), respectively. Cardiovascular and malignancy events were similar 
      between groups, although analysis of these were limited by sample size and study 
      duration. CONCLUSION: The safety of daprodustat was comparable to ESA in this 
      pooled analysis, although further large-scale research is needed to evaluate 
      long-term risks including cardiovascular and malignancy events.
CI  - (c) 2022 GlaxoSmithKline. Therapeutic Apheresis and Dialysis published by John 
      Wiley & Sons Australia, Ltd on behalf of International Society for Apheresis and 
      Japanese Society for Apheresis.
FAU - Nangaku, Masaomi
AU  - Nangaku M
AD  - Division of Nephrology and Endocrinology, The University of Tokyo Graduate School 
      of Medicine, Tokyo, Japan.
FAU - Akizawa, Tadao
AU  - Akizawa T
AUID- ORCID: 0000-0002-6150-9201
AD  - Division of Nephrology, Department of Medicine, Showa University School of 
      Medicine, Tokyo, Japan.
FAU - Nagakubo, Takashi
AU  - Nagakubo T
AD  - Biostatistics, GlaxoSmithKline, Tokyo, Japan.
FAU - Yonekawa, Taeko
AU  - Yonekawa T
AD  - Medicines Development, GlaxoSmithKline, Tokyo, Japan.
FAU - Kimura, Toshifumi
AU  - Kimura T
AUID- ORCID: 0000-0001-8831-7659
AD  - Medical Affairs, GlaxoSmithKline, Tokyo, Japan.
FAU - Endo, Yukihiro
AU  - Endo Y
AD  - Medicines Development, GlaxoSmithKline, Tokyo, Japan.
FAU - Cobitz, Alexander
AU  - Cobitz A
AD  - Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania, USA.
LA  - eng
GR  - GlaxoSmithKline/
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20220406
PL  - Australia
TA  - Ther Apher Dial
JT  - Therapeutic apheresis and dialysis : official peer-reviewed journal of the 
      International Society for Apheresis, the Japanese Society for Apheresis, the 
      Japanese Society for Dialysis Therapy
JID - 101181252
RN  - 0 (GSK1278863)
RN  - 0 (Hemoglobins)
RN  - 0 (Hematinics)
SB  - IM
MH  - Humans
MH  - Japan/epidemiology
MH  - Hemoglobins/analysis
MH  - *Anemia/drug therapy/epidemiology/etiology
MH  - *Renal Insufficiency, Chronic/therapy
MH  - *Hematinics
PMC - PMC9790622
OTO - NOTNLM
OT  - anemia
OT  - chronic kidney disease
OT  - daprodustat
OT  - dialysis
OT  - nondialysis
OT  - safety
COIS- Masaomi Nangaku: has received grants and personal fees from Astellas Pharma Inc. 
      (Astellas), Chugai Pharmaceutical Co., Ltd. (Chugai), Daiichi Sankyo Co., Ltd., 
      GlaxoSmithKline (GSK), Kyowa Kirin Co., Ltd. (KKC), Mitsubishi Tanabe Pharma, and 
      Torii Pharmaceutical Co., Ltd. (Torii); grants from Bayer Yakuhin, Ltd. (Bayer), 
      Ono Pharmaceutical Co., Ltd. (Ono), and Takeda Pharmaceutical Company Ltd. 
      (Takeda); and personal fees from AstraZeneca and JT Pharmaceuticals. Tadao 
      Akizawa: has received personal fees from Astellas, Bayer, Chugai, Fuso, GSK, JT 
      Pharmaceuticals, KKC, Kissei, Nipro Corporation, Ono, Otsuka, Torii, Mitsubishi 
      Tanabe Pharma, and Sanwa Chemical Industrial Co., Ltd. Y.T. has received personal 
      fees from Chugai, GSK, KKC, and Torii. Takashi Nagakubo, Toshifumi Kimura, 
      Yukihiro Endo, and Alexander Cobitz are employees and stockholders in GSK. Taeko 
      Yonekawa is an employee of GSK.
EDAT- 2022/03/22 06:00
MHDA- 2022/11/16 06:00
PMCR- 2022/12/25
CRDT- 2022/03/21 12:20
PHST- 2022/03/09 00:00 [revised]
PHST- 2022/01/25 00:00 [received]
PHST- 2022/03/16 00:00 [accepted]
PHST- 2022/03/22 06:00 [pubmed]
PHST- 2022/11/16 06:00 [medline]
PHST- 2022/03/21 12:20 [entrez]
PHST- 2022/12/25 00:00 [pmc-release]
AID - TAP13839 [pii]
AID - 10.1111/1744-9987.13839 [doi]
PST - ppublish
SO  - Ther Apher Dial. 2022 Dec;26(6):1065-1078. doi: 10.1111/1744-9987.13839. Epub 
      2022 Apr 6.