Table 3 Incidence of AEs in all treatment groups (safety population)

From: Long-term safety, tolerability, and antihypertensive efficacy of aliskiren, an oral direct renin inhibitor, in Japanese patients with hypertension

 

Aliskiren monotherapy (N=344) N (%)

Aliskiren+CCB (n=119) n (%)

Aliskiren+diuretic (n=91) n (%)

Any AE

250 (72.7)

86 (72.3)

63 (69.2)

SAEs

5 (1.5)

2 (1.7)

3 (3.3)

Discontinuations due to AE

13 (3.8)

6 (5.0)

6 (6.6)

AEs occurring in ⩾3% of patients in any group

 Nasopharyngitis

118 (34.3)

40 (33.6)

23 (25.3)

 Back pain

12 (3.5)

3 (2.5)

3 (3.3)

 Seasonal allergy

11 (3.2)

0

3 (3.3)

 Laryngopharyngitis

8 (2.3)

1 (0.8)

4 (4.4)

Notable laboratory abnormalities

n=175 N (%)a

n=90 N (%)b

n=79 N (%)c

 Serum potassium

   

<3.5 mmol l−1

2 (1.1)

3 (3.3)

2 (2.5)

>5.5 mmol l−1

0

1 (1.1)

0

 Serum creatinine >176.8 μmol l−1

0

0

1 (1.3)

 BUN >14.3 mmol l−1

0

0

1 (1.3)

  1. Abbreviations: AE, adverse event; BUN, blood urea nitrogen; CCB, calcium channel blocker; SAE, serious adverse event.
  2. aPatients who received only aliskiren monotherapy.
  3. bPatients who received at least one dose of optional CCB add-on therapy.
  4. cPatients who received at least one dose of optional diuretic add-on therapy.
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