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Table 4 Study participants with adverse events during the open-label treatment period by onset dosing regimen

From: Olmesartan/amlodipine/hydrochlorothiazide in participants with hypertension and diabetes, chronic kidney disease, or chronic cardiovascular disease: a subanalysis of the multicenter, randomized, double-blind, parallel-group TRINITY study

 

Diabetes

CKD

Chronic CVD

All data n (%)

OM 40/ AML 5/ HCTZ 12.5 mg

OM 40/ AML 5/ HCTZ 25 mg

OM 40/ AML 10/ HCTZ 12.5 mg

OM 40/ AML 10/ HCTZ 25 mg

OM 40/ AML 5/ HCTZ 12.5

OM 40/ AML 5/ HCTZ 25 mg

OM 40/ AML 10/ HCTZ 12.5 mg

OM 40/ AML 10/ HCTZ 25 mg

OM 40/ AML 5/ HCTZ 12.5

OM 40/ AML 5/ HCTZ 25 mg

OM 40/ AML 10/ HCTZ 12.5 mg

OM 40/ AML 10/ HCTZ 25 mg

 

(n=334)

(n=139)

(n=143)

(n=203)

(n=93)

(n=35)

(n=32)

(n=39)

(n=191)

(n=74)

(n=70)

(n=95)

All AEs*

135 (40.4)

40 (28.8)

48 (33.6)

120 (59.1)

43 (46.2)

13 (37.1)

15 (46.9)

23 (59.0)

88 (46.1)

25 (33.8)

20 (28.6)

54 (56.8)

Severe AEs

12 (3.6)

2 (1.4)

4 (2.8)

8 (3.9)

4 (4.3)

1 (2.9)

1 (3.1)

4 (10.3)

7 (3.7)

1 (1.4)

3 (4.3)

5 (5.3)

Drug-related AEs †

37 (11.1)

9 (6.5)

12 (8.4)

28 (13.8)

14 (15.1)

4 (11.4)

5 (15.6)

8 (20.5)

30 (15.7)

8 (10.8)

4 (5.7)

24 (25.3)

Discontinuations

            

AEs

5 (1.5)

2 (1.4)

1 (0.7)

9 (4.4)

8 (8.6)

1 (2.9)

2 (6.3)

3 (7.7)

9 (4.7)

1 (1.4)

0

6 (6.3)

AEs starting in open-label extension period

5 (1.5)

2 (1.4)

1 (0.7)

8 (3.9)

7 (7.5)

1 (2.9)

2 (6.3)

3 (7.7)

9 (4.7)

1 (1.4)

0

6 (6.3)

Drug-related AEs†

3 (0.9)

2 (1.4)

1 (0.7)

3 (1.5)

6 (6.5)

0

2 (6.3)

2 (5.1)

6 (3.1)

0

0

3 (3.2)

AEs (>5% in any treatment group) ‡

            

Dizziness

10 (3.0)

4 (2.9)

3 (2.1)

10 (4.9)

6 (6.5)

0

3 (9.4)

2 (5.1)

7 (3.7)

0

2 (2.9)

6 (6.3)

Urinary tract infection

13 (3.9)

4 (2.9)

2 (1.4)

9 (4.4)

1 (1.1)

1 (2.9)

0

3 (7.7)

4 (2.1)

0

1 (1.4)

3 (3.2)

Upper respiratory tract infection

8 (2.4)

0

6 (4.2)

11 (5.4)

5 (5.4)

0

2 (6.3)

2 (5.1)

3 (1.6)

1 (1.4)

3 (4.3)

3 (3.2)

Nasopharyngitis

2 (0.6)

3 (2.2)

2 (1.4)

8 (3.9)

2 (2.2)

1 (2.9)

1 (3.1)

3 (7.7)

6 (3.1)

1 (1.4)

0

3 (3.2)

Cough

6 (1.8)

4 (2.9)

3 (2.1)

4 (2.0)

1 (1.1)

1 (2.9)

2 (6.3)

2 (5.1)

0

1 (1.4)

2 (2.9)

5 (5.3)

  1. *Adverse events starting before the open-label extension period and not resolved by week 12 were counted under the final dosing regimen.
  2. †Drug-related was defined as definitely, probably, or possibly related to randomized study medication.
  3. ‡AEs presented occurred in >5% and at least 3 study participants in any treatment group. Although a participant may have had 2 or more AEs, the participant is counted only once within a category. The same participant may appear in different categories.
  4. AML, amlodipine besylate; CVD, cardiovascular disease; CKD, chronic kidney disease; HCTZ, hydrochlorothiazide; OM, olmesartan medoxomil; TEAE, treatment-emergent adverse event.
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Cardiovascular Diabetology

ISSN: 1475-2840