PMID- 38326092
OWN - NLM
STAT- MEDLINE
DCOM- 20240409
LR  - 20240409
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 26
IP  - 5
DP  - 2024 May
TI  - Erythropoiesis and estimated fluid volume regulation following initiation of 
      ipragliflozin treatment in patients with type 2 diabetes mellitus and chronic 
      kidney disease: A post-hoc analysis of the PROCEED trial.
PG  - 1723-1730
LID - 10.1111/dom.15481 [doi]
AB  - AIMS: To analyse the changes in erythropoietic and estimated fluid volume 
      parameters after the initiation of ipragliflozin, a sodium-glucose co-transporter 
      2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) and chronic kidney 
      disease (CKD). METHODS: This was a post-hoc analysis of the PROCEED trial, which 
      evaluated the effect of 24-week ipragliflozin treatment on endothelial 
      dysfunction in patients with T2DM and CKD. We evaluated the changes in 
      erythropoietic and estimated fluid volume parameters from baseline to 24 weeks 
      post-treatment in 53 patients who received ipragliflozin (ipragliflozin group) 
      and 55 patients with T2DM and CKD without sodium-glucose co-transporter 2 
      inhibitors (control group), a full analysis set of the PROCEED trial. RESULTS: 
      The increases in haemoglobin [estimated group difference, 0.5 g/dl; 95% 
      confidence interval (CI), 0.3-0.8; p < .001], haematocrit (estimated group 
      difference, 2.2%; 95% CI, 1.3-3.1; p < .001) and erythropoietin (estimated 
      log-transformed group difference, 0.1; 95% CI, 0.01-0.3; p = .036) were 
      significantly greater in the ipragliflozin group than those in the control group. 
      Ipragliflozin treatment was significantly associated with an increase in 
      erythropoietin, independent of the corresponding change in haemoglobin 
      (beta = 0.253, p < .001) or haematocrit (beta = 0.278, p < .001). Reductions in 
      estimated plasma volume (estimated group difference, -7.94%; 95% CI, -11.6 to 
      -4.26%; p < .001) and estimated extracellular volume (estimated group difference, 
      -181.6 ml; 95% CI, -275.7 to -87.48 ml; p < .001) were significantly greater in 
      the ipragliflozin group than those in the control group. CONCLUSIONS: 
      Erythropoiesis was enhanced and estimated fluid volumes were reduced by 
      ipragliflozin in patients with T2DM and CKD. CLINICAL TRIAL: PROCEED trial 
      (registration number: jRCTs071190054).
CI  - (c) 2024 John Wiley & Sons Ltd.
FAU - Maruhashi, Tatsuya
AU  - Maruhashi T
AD  - Department of Regenerative Medicine, Research Institute for Radiation Biology and 
      Medicine, Hiroshima University, Hiroshima, Japan.
FAU - Tanaka, Atsushi
AU  - Tanaka A
AUID- ORCID: 0000-0003-3352-7661
AD  - Department of Cardiovascular Medicine, Saga University, Saga, Japan.
FAU - Takahashi, Kanae
AU  - Takahashi K
AD  - Department of Biostatistics, Hyogo Medical University, Nishinomiya, Japan.
FAU - Higashi, Yukihito
AU  - Higashi Y
AUID- ORCID: 0000-0001-5813-3672
AD  - Department of Regenerative Medicine, Research Institute for Radiation Biology and 
      Medicine, Hiroshima University, Hiroshima, Japan.
AD  - Division of Regeneration and Medicine, Medical Center for Translational and 
      Clinical Research, Hiroshima University Hospital, Hiroshima, Japan.
FAU - Node, Koichi
AU  - Node K
AUID- ORCID: 0000-0002-2534-0939
AD  - Department of Cardiovascular Medicine, Saga University, Saga, Japan.
CN  - PROCEED trial investigators
LA  - eng
PT  - Journal Article
DEP - 20240207
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 3N2N8OOR7X (ipragliflozin)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 11096-26-7 (Erythropoietin)
RN  - IY9XDZ35W2 (Glucose)
RN  - 0 (Hemoglobins)
RN  - 0 (Symporters)
RN  - 9NEZ333N27 (Sodium)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Glucosides)
RN  - 0 (Thiophenes)
SB  - IM
MH  - Humans
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy
MH  - Erythropoiesis
MH  - *Sodium-Glucose Transporter 2 Inhibitors/adverse effects
MH  - *Renal Insufficiency, Chronic/complications/drug therapy/chemically induced
MH  - *Erythropoietin/therapeutic use
MH  - Glucose/therapeutic use
MH  - Hemoglobins/therapeutic use
MH  - *Symporters/therapeutic use
MH  - Sodium
MH  - Hypoglycemic Agents/therapeutic use
MH  - *Glucosides
MH  - *Thiophenes
OTO - NOTNLM
OT  - chronic kidney disease
OT  - erythropoietin
OT  - ipragliflozin
OT  - sodium-glucose co-transporter 2 inhibitor
OT  - type 2 diabetes mellitus
EDAT- 2024/02/08 00:42
MHDA- 2024/04/09 06:45
CRDT- 2024/02/07 21:39
PHST- 2024/01/11 00:00 [revised]
PHST- 2023/11/20 00:00 [received]
PHST- 2024/01/18 00:00 [accepted]
PHST- 2024/04/09 06:45 [medline]
PHST- 2024/02/08 00:42 [pubmed]
PHST- 2024/02/07 21:39 [entrez]
AID - 10.1111/dom.15481 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2024 May;26(5):1723-1730. doi: 10.1111/dom.15481. Epub 2024 
      Feb 7.