Prespecified pooled analysis
In adult patients with CKD and T2D
A robust safety profile for Firialta was demonstrated in >13,000 patients1
The most commonly reported AE with Firialta was hyperkalaemia
Treatment-emergent AE
Firialta % (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 Firialta
and placebo, respectively
similar between Firialta
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 Firialta to your standard of care with confidence2
Findings from a prespecified pooled safety analysis demonstrate
Firialta had a modest impact on SBP levels1*
Firialta had no meaningful impact on HbA1c vs placebo3,4†
| * | The effects of Firialta and placebo on mean SBP (pooled safety analysis set). Data are shown as mean ± standard deviation.1 |
| † | Hypotension was reported more commonly with Firialta than with placebo and in ≥1% of patients treated with Firialta .2 |
AE=adverse event; CKD=chronic kidney disease; HbA1c=glycated haemoglobin; SBP=systolic blood pressure; T2D=type 2 diabetes.
References:
- Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777. Return to content
- Firialta® Product Insert approved by NPRA 4th April 2024. 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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