Table 5.
Transience and Reversibility of Creatinine Elevations (Safety Population)
| Parameter | AZL‐M/CLD (n=418) | OLM/HCTZ (n=419) |
|---|---|---|
| Patients with creatinine elevations ≥50% from baseline and >ULN, n/N (%) | ||
| Any postbaseline visitc | 58/408 (14.2) | 24/414 (5.8) |
| Final visit | 24/408 (5.9) | 4/414 (1.0) |
| Two or more consecutive elevationsc | 21/408 (5.1) | 5/414 (1.2) |
| Reversibility of creatinine elevations ≥30% from baseline and >ULN at final visit, n/N (%) | ||
| Resolved after final visitc | 30/35 (85.7) | 5/9 (55.6) |
| Unresolved | 2/35 (5.7) | 1/9 (11.1) |
| Voluntary withdrawala | 1/35 (2.6) | 1/9 (11.1) |
| Lost to follow‐upb | 0/35 | 2/9 (22.2) |
| Early termination due to other reasonc | 2/35 (5.7) | 0/9 |
Abbreviations: AZL‐M/CLD, azilsartan medoxomil/chlorthalidone; OLM/HCTZ, olmesartan medoxomil/hydrochlorothiazide.
Experienced one or more creatinine elevation with a prespecified percentage ≥baseline and >upper limit of normal (ULN).
Two or more creatinine values that met the criteria at consecutive visits (may include final visit and unscheduled visits through 7 days after the last dose of study medication).
Primarily patients who resolved during follow‐up, but also patients who were considered resolved at final visit relative to screening values; all patients resolved to ≤0.2 mg/dL above the baseline or screening value.
Patient withdrew for personal reasons. Creatinine elevation at final visit with no follow‐up available.
Patients completed the study and had creatinine elevation at final visit but lost to follow‐up.
Patients had creatinine elevation at final visit but was subsequently discharged due to adverse event of renal cancer (1) and noncompliance (1).