Table 3.
Key Serum Laboratory Parameters During the Open‐Label Phase (Safety Population)
| Parameter | Total Cohort (N=418) | AZL‐Ma (n=179) | AZL‐M+CLDb (n=239) |
|---|---|---|---|
| Creatinine | |||
| ≥2 consecutive elevations (≥1.5× baseline and >ULN), n/N (%) | 6/400 (1.5)g | 1/163 (0.6) g | 5/237 (2.1) |
| Potassium | |||
| Baseline, mean±SD, mmol/Lc | 4.16±0.39 | 4.19±0.38 | 4.14±0.40 |
| Change, mean±SD, mmol/Lc | 0.06±0.42 | 0.21±0.36 | −0.01±0.43 |
| Shift from normal to low, n/N, %d | 17/288 (5.9) | 1/97 (1.0) | 16/191 (8.4) |
| Sodium | |||
| Shift from normal to low, n/N (%)d | 7/304 (2.3) | 1/101 (1.0) | 6/203 (3.0) |
| Uric acid | |||
| Shift from normal to high, n/N (%)e | 67/265 (25.3) | 11/88 (12.5) | 56/177 (31.6) |
| Fasting glucose | |||
| Baseline, mean±SD, mmol/Lf | 5.86±1.31 | 5.82±1.20 | 5.89±1.38 |
| Change, mean±SD, mmol/Lf | 0.35±1.30 | 0.32±1.21 | 0.37±1.34 |
Abbreviation: SD, standard deviation. Note that the individual columns in italics do not represent randomized groups and are part of a single cohort. aPatients who did not require additional treatment with chlorthalidone (CLD) during the open‐label phase. bPatients who required additional treatment with CLD after week 8 during the open‐label phase. cFor potassium, 1 mmol/L=1 mEq/L. dDefinitions of “low:” sodium (mmol/L) <132 (18–59 y), <135 (>59 y); potassium (mmol/L) <3.4. eDefinitions of “high:” uric acid (μmol/L) >125 (18–50 y), >149 (>50 y). fTo convert mmol/L to mg/dL, multiply by 18. gOne additional patient had a creatinine elevation (≥1.5× baseline and greater than the upper limit of normal [ULN]) at the end of the open‐label phase and a consecutive elevation at the start of the double‐blind phase; the patient was receiving azilsartan medoxomil (AZL‐M) 80 mg (without chlorthalidone [CLD]) and was randomized to the AZL‐M group in the double‐blind phase.