Table 3 Treatment-emergent adverse events occurring in ≥2% of patients and adverse drug reactions occurring in ≥2 patients in any group (safety analysis set)

From: Long-term phase 3 study of esaxerenone as mono or combination therapy with other antihypertensive drugs in patients with essential hypertension

 

Esaxerenone

 

Monotherapy (n = 245)

 + CCB (n = 59)

 + RAS inhibitor (n = 64)

Total (N = 368)

Any TEAE

160 (65.3)

46 (78.0)

47 (73.4)

253 (68.8)

 Viral upper respiratory tract infection

54 (22.0)

21 (35.6)

26 (40.6)

101 (27.4)

 Upper respiratory tract infection

8 (3.3)

0 (0.0)

0 (0.0)

8 (2.2)

 Upper respiratory tract inflammation

8 (3.3)

3 (5.1)

4 (6.3)

15 (4.1)

 Influenza

6 (2.4)

1 (1.7)

4 (6.3)

11 (3.0)

 Bronchitis

8 (3.3)

0 (0.0)

0 (0.0)

8 (2.2)

 Gastroenteritis

7 (2.9)

1 (1.7)

2 (3.1)

10 (2.7)

 Dental caries

5 (2.0)

0 (0.0)

3 (4.7)

8 (2.2)

 Diarrhea

7 (2.9)

1 (1.7)

2 (3.1)

10 (2.7)

 Headache

9 (3.7)

0 (0.0)

0 (0.0)

9 (2.4)

 Dermatitis contact

10 (4.1)

0 (0.0)

1 (1.6)

11 (3.0)

 Arthralgia

3 (1.2)

5 (8.5)

1 (1.6)

9 (2.4)

 Back pain

6 (2.4)

2 (3.4)

4 (6.3)

12 (3.3)

 Renal impairmenta

6 (2.4)

0 (0.0)

2 (3.1)

8 (2.2)

 Hyperuricemia

3 (1.2)

6 (10.2)

0 (0.0)

9 (2.4)

Laboratory test

42 (17.1)

7 (11.9)

11 (17.2)

60 (16.3)

 Serum K+ increaseda

19 (7.8)

1 (1.7)

6 (9.4)

26 (7.1)

Any adverse drug reaction

45 (18.4)

14 (23.7)

12 (18.8)

71 (19.3)

 Anemia

3 (1.2)

3 (5.1)

0 (0.0)

6 (1.6)

 Hyperuricemia

1 (0.4)

6 (10.2)

0 (0.0)

7 (1.9)

 Dizziness

0 (0.0)

1 (1.7)

1 (1.6)

2 (0.5)

 Dizziness postural

1 (0.4)

0 (0.0)

1 (1.6)

2 (0.5)

 Headache

2 (0.8)

0 (0.0)

0 (0.0)

2 (0.5)

 Hepatic function abnormal

3 (1.2)

3 (5.1)

0 (0.0)

6 (1.6)

 Renal impairment

4 (1.6)

0 (0.0)

1 (1.6)

5 (1.4)

Laboratory test

26 (10.6)

3 (5.1)

8 (12.5)

37 (10.1)

 Serum K+ increased

18 (7.3)

1 (1.7)

6 (9.4)

25 (6.8)

 Serum uric acid increased

2 (0.8)

0 (0.0)

0 (0.0)

2 (0.5)

 Gamma-glutamyltransferase increased

2 (0.8)

0 (0.0)

0 (0.0)

2 (0.5)

 Platelet count decreased

1 (0.4)

0 (0.0)

1 (1.6)

2 (0.5)

 White blood cell count decreased

1 (0.4)

0 (0.0)

1 (1.6)

2 (0.5)

 Lymphocyte percentage decreased

1 (0.4)

1 (1.7)

0 (0.0)

2 (0.5)

Serum K+ ≥5.5 mEq/L at any visit

14 (5.7)

2 (3.4)

4 (6.3)

20 (5.4)

Serum K+ ≥6.0 mEq/L or ≥5.5 mEq/L on two consecutive measurements

4 (1.6)

0 (0.0)

0 (0.0)

4 (1.1)

 Serum K+ ≥6.0 mEq/L

2 (0.8)

0 (0.0)

0 (0.0)

2 (0.5)

 Serum K+ ≥5.5 mEq/L on two consecutive measurements

3 (1.2)

0 (0.0)

0 (0.0)

3 (0.8)

  1. Values are number of patients (%)
  2. CCB calcium channel blocker, RAS renin–angiotensin system, TEAE treatment-emergent adverse events
  3. aRenal impairment and serum K+ increased were defined as adverse events based on the judgement of the primary investigator as no clearly defined threshold values were available for these events
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