Prespecified pooled analysis
In adult patients with CKD and T2D
A robust safety profile for Kerendia was demonstrated in >13,000 patients1
The most commonly reported AE with Kerendia was hyperkalaemia
Treatment-emergent AE
Kerendia % (n=6510)
Placebo % (n=6489)
Any AE
86.1 (5602)
86.4 (5607)
Any serious AE
31.6 (2060)
33.7 (2186)
Hyperkalaemia
14.0 (912)
6.9 (448)
Leading to hospitalisation
0.9 (61)
0.2 (10)
Leading to permanent treatment discontinuation
1.7 (110)
0.6 (38)
Leading to death
0
0
Hormonal symptoms were
similar between Kerendia
and placebo, respectively
similar between Kerendia
and placebo, respectively
Gynaecomastia
0.1% (8) vs 0.2% (11)
0.1% (8) vs 0.2% (11)
Reproductive system
and breast disorder
5.6% (362) vs 5.6% (361)
and breast disorder
5.6% (362) vs 5.6% (361)
Breast hyperplasia
0% vs <0.1% (5)
0% vs <0.1% (5)
Add Kerendia to your standard of care with confidence2
Findings from a prespecified pooled safety analysis demonstrate
Kerendia had a modest impact on SBP levels1*
Kerendia had no meaningful impact on HbA1c vs placebo3,4†
| * | The effects of Kerendia and placebo on mean SBP (pooled safety analysis set). Data are shown as mean ± standard deviation.1 |
| † | Hypotension was reported more commonly with Kerendia than with placebo and in ≥1% of patients treated with Kerendia.2 |
AE=adverse event; CKD=chronic kidney disease; HbA1c=glycated haemoglobin; SBP=systolic blood pressure; T2D=type 2 diabetes.
References:
- Kerendia Product Insert approved by HSA October 2022. Return to content
- Kerendia European Summary of Product Characteristics (SmPC); February 2023. Return to content
- Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845. Return to content
- Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956. Return to content
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