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
Authors' conclusion
Erythropoiesis was enhanced and estimated fluid volumes were reduced by ipragliflozin in patients with T2DM and CKD.
Study context
- Population
- Patients with T2D and chronic kidney disease (CKD) in the PROCEED trialfull analysis set
- Comparison
- Ipragliflozin for 24 weeks vs no SGLT2i
- Primary endpoint
- Changes in erythropoietic and estimated fluid volume parameters
- Follow-up
- Baseline to 24 weeks
Methodological detailsfull analysis set
- Full analysis set
Primary result
As reported in the abstract
Changes in erythropoietic parameters (haemoglobin, haematocrit, erythropoietin)
Estimated group difference, haemoglobin increase, g/dl (95% CI)P value
Ipragliflozinvs Control
0.5(0.3–0.8)
P < 0.001Estimated group difference, haematocrit increase, % (95% CI)P value
Ipragliflozinvs Control
2.2(1.3–3.1)
P < 0.001Estimated log-transformed group difference, erythropoietin increase (95% CI)P value
Ipragliflozinvs Control
0.1(0.01–0.3)
P = 0.036- Ipragliflozin associated with erythropoietin increase independent of haemoglobin change (β)
- 0.253, p < .001
- Ipragliflozin associated with erythropoietin increase independent of haematocrit change (β)
- 0.278, p < .001
Further findings
| Outcome | Estimated group difference, estimated plasma volume (%) (95% CI) | P value | |
|---|---|---|---|
| Changes in estimated fluid volume (estimated plasma volume, estimated extracellular volume) · baseline to 24 weeksIpragliflozinvs ControlGreater reduction with Ipragliflozin | −7.94 (−11.6 to −4.26%) | P < 0.001 | |
| −15−10−505Difference, % (linear scale) |
| Outcome | Estimated group difference, estimated extracellular volume (ml) (95% CI) | P value | |
|---|---|---|---|
| Changes in estimated fluid volume (estimated plasma volume, estimated extracellular volume) · baseline to 24 weeksIpragliflozinvs ControlGreater reduction with Ipragliflozin | −181.6 (−275.7 to −87.48 ml) | P < 0.001 | |
| −400−2000200Difference, ml (linear scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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. Diabetes Obes Metab. Published 7 February 2024. doi:10.
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