Table II.
Safety and Tolerability of Study Treatments (Safety Seta)
| Aliskiren/HCTZ 300/25 mg (±AML 5 mg) (n=227) | HCTZ 25 mg (±AML 5 mg) (n=223) | |
|---|---|---|
| Any adverse event | 98 (43.2) | 100 (44.8) |
| Serious adverse event | 4 (1.8) | 3 (1.3) |
| Discontinuation due to adverse event | 13 (5.7) | 7 (3.1) |
| Most frequent adverse events (≥2% of patients in any treatment group) | ||
| Dizziness | 13 (5.7) | 9 (4.0) |
| Cough | 6 (2.6) | 3 (1.3) |
| Headache | 4 (1.8) | 17 (7.6) |
| Hypokalemia | 4 (1.8) | 7 (3.1) |
| Upper respiratory tract infection | 4 (1.8) | 8 (3.6) |
| Urinary tract infection | 3 (1.3) | 5 (2.2) |
| Peripheral edema | 2 (0.9) | 5 (2.2) |
| Sinusitis | 0 | 5 (2.2) |
| Laboratory abnormalities, No. | 224b | 222b |
| Serum potassium, mmol/L | ||
| <3.5 | 22 (9.8) | 51 (23.0) |
| >5.5 | 3 (1.3) | 3 (1.4) |
| ≥6.0 | 1 (0.4) | 2 (0.9) |
| Serum creatinine | ||
| >176.8 μmol/L | 1 (0.4) | 0 |
| Blood urea nitrogen | ||
| >14.28 mmol/L | 1 (0.4) | 0 |
Data are shown as number (percentage) of patients unless otherwise indicated. Abbreviations: AML, amlodipine; HCTZ, hydrochlorothiazide. aSafety set includes all patients that received at least one dose of study medication. bNumber of patients with evaluable laboratory assessments.