Prespecified pooled analysis

 

In adult patients with CKD and T2D

A robust safety profile for Kerendia was demonstrated in >13,000 patients

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

Gynaecomastia

0.1% (8) vs 0.2% (11)

Reproductive system

and breast disorder

5.6% (362) vs 5.6% (361)

Breast hyperplasia

0% vs <0.1% (5)

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Findings from a prespecified pooled safety analysis demonstrate

Kerendia had a modest impact on SBP levels
*

Safety Graph
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Kerendia had no meaningful impact on HbA1c vs placebo
†

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    Abbreviationsexpand_less

    *The effects of Kerendia and placebo on mean SBP (pooled safety analysis set). Data are shown as mean ± standard deviation.

    †Hypotension was reported more commonly with Kerendia than with placebo and in ≥1% of patients treated with Kerendia.


    AE=adverse event; CKD=chronic kidney disease; HbA1c=glycated haemoglobin; SBP=systolic blood pressure; T2D=type 2 diabetes.

    Referencesexpand_less
    • 1
      Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777.
    • 2
      Kerendia Prescribing Information, India 2023.
    • 3
      Bakris GL, et al; FIDELIO-DKD Investigators. N Engl J Med. 2020;383(23):2219-2229. doi:10.1056/NEJMoa2025845.
    • 4
      Pitt B, et al. N Engl J Med. 2021;385(24):2252-2263. doi:10.1056/NEJMoa2110956.