Table III.
Prespecified Laboratory Abnormalities
| (A) Short‐Term, Placebo‐Controlled Studies | ||||||
|---|---|---|---|---|---|---|
| Laboratory Variable | Aliskiren (150 mg) n=1435 | Aliskiren (300 mg) n=1551 | Aliskiren/HCTa n=1464 | HCTb n=555 | Aliskiren/ Valsartanc n=624 | ARBd (50–300 mg) n=1069 |
| Potassium level | ||||||
| <3.5 mEq/L | 13 (1.0) | 19 (1.3) | 21 (1.8) | 14 (3.1) | 13 (2.2) | 26 (2.5) |
| >5.5 mEq/L | 14 (1.0) | 24 (1.7) | 6 (0.5) | 4 (0.9) | 20 (3.4) | 7 (0.7) |
| ≥6.0 mEq/L | 5 (0.4) | 7 (0.5) | 1 (0.1) | 1 (0.2) | 2 (0.3) | 5 (0.5) |
| ≥7.0 mEq/L | 0 | 3 (0.2) | 0 | 0 | 2 (0.3) | 2 (0.2) |
| BUN >40 mg/dL | 0 | 3 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Creatinine level >2.0 mg/dL | 0 | 4 (0.3) | 0 | 0 | 4 (0.7) | 2 (0.2) |
| eGFR <30 mL/min/1.73 m2 | 0 | 1 (0.1) | 0 | 0 | 2 (0.3) | 1 (0.1) |
| (B) Longer‐Term, Active‐Controlled Studies | ||||||
|---|---|---|---|---|---|---|
| Laboratory Variable | Aliskiren Monotherapy (150 and 300 mg) n=1593 | Aliskiren (150 mg) n=871 | Aliskiren (300 mg) n=722 | HCTe n=558 | Aliskiren/ losartanf n=155 | Losartang n=154 |
| Potassium level | ||||||
| <3.5 mEq/L | 54 (3.5) | 37 (4.4) | 17 (2.4) | 96 (17.8) | 8 (5.2) | 11 (7.2) |
| >5.5 mEq/L | 56 (3.6) | 16 (1.9) | 40 (5.7) | 20 (3.7) | 5 (3.3) | 5 (3.3) |
| ≥6.0 mEq/L | 25 (1.6) | 7 (0.8) | 18 (2.6) | 10 (1.9) | 1 (0.7) | 1 (0.7) |
| ≥7.0 mEq/L | 5 (0.3) | 0 | 5 (0.7) | 3 (0.6) | 0 | 1 (0.7) |
| BUN >40 mg/dL | 10 (0.6) | 6 (0.7) | 4 (0.6) | 4 (0.7) | 0 | 2 (1.3) |
| Creatinine level >2.0 mg/dL | 4 (0.3) | 2 (0.2) | 2 (0.3) | 0 | 1 (0.7) | 1 (0.7) |
| eGFR <30 mL/min/1.73 m2 | 5 (0.3) | 3 (0.4) | 2 (0.3) | 0 | 1 (0.7) | 2 (1.3) |
Abbreviations: ARB, angiotensin receptor blocker; BUN, blood urea nitrogen; eGFR, estimated glomerular filtration rate; HCT, hydrochlorothiazide. Values are expressed as number (percentage) of patients who had laboratory measurements and are summarized according to the treatment to which patients were randomized. aAliskiren/HCT 150/6.25 mg to 300/25 mg. b6.25 to 25 mg. cAliskiren/valsartan 75/80 mg to 300/320 mg. dLosartan 50 mg, irbesartan 150 mg, or valsartan 80 mg to 320 mg. eHCT 12.5 mg to 25 mg; HCT/amlodipine 25/5 mg to 10 mg (in one study, amlodipine was added to HCT if blood pressure was not controlled to <140/90 mm Hg). 22 fAliskiren/losartan 150/50 mg to 300/100 mg. gLosartan 50 mg to 100 mg.