Prespecified pooled analysis

In adult patients with CKD and T2D

A robust safety profile for Firialta was demonstrated in >5,700 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

Hormonal symptoms were
similar between Firialta
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)

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 placebo^3,4†

Firialta was generally well tolerated^1,2

Treatment-emergent AE

Firialta % (N=2827)

Placebo % (N=2831)

Any AE

87.3 (2468)

87.5 (2478)

Any serious AE

31.9 (902)

34.3 (971)

Adverse reactions reported more commonly with Firialta than with placebo and in ≥1% of patients treated with Firialta

Hyperkalaemia

18.3 (516)

9.0 (255)

Leading to hospitalisation

1.4 (40)

0.3 (8)

Leading to permanent treatment discontinuation

2.3 (64)

0.9 (25)

Hypotension

4.5 (126)

3.1 (87)

Hyponatraemia

1.3 (38)

0.6 (18)

Rates of discontinuation due to any AEs were 7.3% for Firialta and 5.9% for placebo²
Regular monitoring of serum potassium is recommended³

There was no increase in gynaecomastia vs placebo³
There was no effect on HbA1c vs placebo³
There was only a modest reduction (~3 mmHg) in mean systolic blood pressure vs placebo^2,3

Most frequently reported AEs

AEs

Firialta
% (N=2827)

Placebo
% (N=2831)

Hyperkalaemia

15.8 (446)

7.8 (221)

Nasopharyngitis

8.5 (241)

9.6 (273)

Hypertension

7.5 (212)

9.6 (273)

Anaemia

7.4 (209)

6.7 (191)

Peripheral oedema

6.6 (186)

10.7 (304)

Diarrhoea

6.5 (184)

6.7 (189)

Upper respiratory tract infection

6.4 (181)

6.7 (189)

Glomerular filtration rate decreased

6.3 (179)

4.7 (133)

Urinary tract infection

6.3 (179)

6.8 (192)

Back pain

6.2 (175)

6.5 (184)

Hypoglycaemia

5.3 (151)

6.9 (194)

Dizziness

5.2 (146)

5.4 (153)

Arthralgia

5.0 (142)

5.3 (149)

Bronchitis

4.7 (134)

5.3 (151)

Constipation

4.6 (131)

5.8 (163)

Pneumonia

4.5 (128)

6.4 (181)

Investigator-reported Renal AEs

Hypotension

4.5 (126)

3.1 (87)

Hyponatraemia

1.3 (38)

0.6 (18)

Acute kidney injury*

4.6 (129)

4.8 (136)

Hospitalisation due to acute kidney injury*

1.9 (53)

1.7 (47)

Discontinuation of trial regimen due to acute kidney injury*

0.2 (5)

0.2 (7)

Hospitalisation due to acute renal failure^†

2.5 (70)

2.5 (71)

Discontinuation of trial regimen due to acute renal failure^†

1.1 (31)

1.3 (36)

^*	These events were classified according to the MedDRA Preferred term.¹
^†	These events were classified according to the standardised MedDRA Query term.¹

Firialta had a modest effect on SBP and no clinically meaningful effects on HbA1c over time^1,2*

In patients treated with Firialta, the mean SBP decreased by 3 mmHg and the mean diastolic BP decreased by 1 to 2 mmHg at month 1, remaining stable thereafter.

The mean reduction in SBP from baseline to month 4 in the Firialta arm was 3.2 mmHg.²

Hormonal symptoms with Firialta were similar to placebo¹

• Gynaecomastia: 0.2% for Firialta, 0.2% for placebo
• Reproductive system and breast disorders: 4.5% for Firialta, 5.2% for placebo
• Breast hyperplasia: 0% for Firialta, 0.1% for placebo

Firialta had a generally manageable impact on serum potassium¹

Maximum mean difference in potassium between groups was 0.23 mmol/L at month 4, remaining stable thereafter²

Regular monitoring of serum potassium is recommended¹

Clinically meaningful hyperkalaemia was manageable^1-3*

Hyperkalaemia-Specific Events

Firialta
% (n=2827)

Placebo
% (n=2831)

Investigator-reported hyperkalaemia^‡

18.3 (516)

9.0 (255)

Hypotension

4.5 (126)

3.1 (87)

Regimen-related

11.8 (333)

4.8 (135)

Leading to permanent discontinuation of study drug

2.3 (64)

0.9 (25)

Leading to hospitalisation

1.4 (40)

0.3 (8)

Serious adverse event^§

1.6 (44)

0.4 (12)

Leading to death

0.0

Potassium Level

Firialta
% (n=2827)

Placebo
% (n=2831)

>5.5

21.4 (597)

9.2 (256)

>6.0

4.5 (126)

1.4 (38)

^*Although hyperkalaemia was increased in the Firialta group, hyperkalaemia was manageable, and clinically meaningful events like study drug discontinuation, hospitalisation, and serious adverse events were low.^1-3

^†Shown are adverse events that occurred during the treatment period, defined as those that started or worsened during Firialta or placebo intake or up to 3 days after any temporary or permanent interruption. A causal relationship between any adverse event and administration of Firialta or placebo was based on the opinion of the reporting investigator.²

^‡Reported by investigators with the use of the MedDRA preferred terms “hyperkalaemia” and “blood potassium increased.”²

^§An adverse event was considered to be serious if it resulted in death, was life-threatening, resulted in inpatient hospitalisation (or prolongation of existing hospitalisation), caused persistent or clinically significant disability or incapacity, was a congenital abnormality or birth defect, or was judged by the investigator to be a serious or important medical event.²

See how to start your patients on Firialta

AE=adverse event; BP=blood pressure; HbA1c=glycated haemoglobin; MedDRA=Medical Dictionary for Regulatory Activities; SBP=systolic blood pressure; SD=standard deviation.

References:

Agarwal R, et al. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777. Return to content
Firialta (SmPC). 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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Please select one of the following:

Prespecified pooled analysis

A robust safety profile for Firialta was demonstrated in >5,700 patients1

Add Firialta to your standard of care with confidence2

Firialta had a modest impact on SBP levels1*

Firialta had no meaningful impact on HbA1c vs placebo3,4†

Firialta was generally well tolerated1,2

There was no increase in gynaecomastia vs placebo3There was no effect on HbA1c vs placebo3There was only a modest reduction (~3 mmHg) in mean systolic blood pressure vs placebo2,3

Firialta had a modest effect on SBP and no clinically meaningful effects on HbA1c over time1,2*

Hormonal symptoms with Firialta were similar to placebo1

Firialta had a generally manageable impact on serum potassium1

Regular monitoring of serum potassium is recommended1

Clinically meaningful hyperkalaemia was manageable1-3*

References:

A robust safety profile for Firialta was demonstrated in >5,700 patients¹

Add Firialta to your standard of care with confidence²

Firialta had a modest impact on SBP levels¹*

Firialta had no meaningful impact on HbA1c vs placebo^3,4†

Firialta was generally well tolerated^1,2

There was no increase in gynaecomastia vs placebo³
There was no effect on HbA1c vs placebo³
There was only a modest reduction (~3 mmHg) in mean systolic blood pressure vs placebo^2,3

Firialta had a modest effect on SBP and no clinically meaningful effects on HbA1c over time^1,2*

Hormonal symptoms with Firialta were similar to placebo¹

Firialta had a generally manageable impact on serum potassium¹

Regular monitoring of serum potassium is recommended¹

Clinically meaningful hyperkalaemia was manageable^1-3*