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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.