Table V.
Clinical Laboratory Evaluation: Summary of Serum hemistry Data From Baseline to End of Study (Safety Cohort)
| Laboratory Test* | Baseline(N=170) | OM 20 mg/d (N=170) | OM 40 mg/d (n=160) | OM/HCTZ 40/12.5 mg/d (n=157) | OM/HCTZ 40/25 mg/d (n=144) |
|---|---|---|---|---|---|
| Total bilirubin, mg/dL | 0.46 | 0.39 | 0.45 | 0.45 | 0.45 |
| AKP, U/L | 81.4 | 77.6 | 78.3 | 80.8 | 79.5 |
| ALT, U/L | 23.3 | 20.8 | 15.3 | 25.8 | 26.7 |
| AST, U/L | 22.8 | 25.8 | 18.5 | 24.1 | 25.0 |
| GGT, U/L | 31.4 | 31.1 | 25.5 | 36.7 | 37.4 |
| Urea nitrogen, mg/dL | 16.4 | 16.8 | 19.0 | 19.2 | 20.6 |
| Creatinine, mg/dL | 0.85 | 0.81 | 0.65 | 0.92 | 0.95 |
| Calcium, mg/dL | 9.48 | 9.53 | 9.63 | 9.61 | 9.68 |
| Phosphorus, mg/dL | 3.46 | 3.49 | 3.38 | 3.54 | 3.65 |
| Total protein, g/dL | 7.18 | 7.06 | 7.20 | 7.26 | 7.27 |
| Albumin, g/dL | 4.10 | 4.18 | 4.15 | 4.10 | 4.10 |
| Sodium, mEq/L | 141.4 | 140.6 | 139.8 | 140.2 | 140.3 |
| Bicarbonate, mEq/L | 25.67 | 25.41 | 24.20 | 27.07 | 27.66 |
| Chloride, mEq/L | 104.2 | 103.5 | 103.8 | 102.6 | 102.0 |
| Cholesterol, mg/dL | 200.0 | 201.7 | 235.3 | 201.5 | 200.6 |
| LDL, mg/dL | 123.8 | 116.3 | 135.0 | 121.5 | 118.3 |
| HDL, mg/dL | 48.4 | 60.3 | 60.3 | 49.6 | 49.6 |
| Triglycerides, mg/dL | 149.0 | 126.2 | 199.7 | 164.4 | 178.0 |
| *Mean values. OM indicates olmesartan medoxomil; HCTZ, hydrochlorothiazide; AKP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ‐glutamyltransferase; LDL, low‐density lipoprotein cholesterol; and HDL, high‐density lipoprotein cholesterol. | |||||