Table 2.
Safety and Tolerability Profile of LCZ696
| Adverse Event (Preferred Term) | Total (N=35) |
|---|---|
| Any adverse events | 17 (48.6) |
| Nasopharyngitis | 6 (17.1) |
| Blood creatine phosphokinase increased | 3 (8.6) |
| Hyperuricemia | 2 (5.7) |
| Alanine aminotransferase increased | 1 (2.9) |
| Aspartate aminotransferase increased | 1 (2.9) |
| Blood alkaline phosphatase increased | 1 (2.9) |
| Blood bilirubin increased | 1 (2.9) |
| Cystitis | 1 (2.9) |
| Dyslipidemia | 1 (2.9) |
| Gamma‐glutamyltransferase increased | 1 (2.9) |
| Gout | 1 (2.9) |
| Headache | 1 (2.9) |
| Hyperlipidemia | 1 (2.9) |
| Pharyngitis | 1 (2.9) |
| Protein urine present | 1 (2.9) |
| Clinically notable changes in laboratory values | |
| Potassium | |
| ≥6.0 mmol/L | 0 (0.0) |
| >5.5 mmol/L | 0 (0.0) |
| <3.5 mmol/L | 2 (5.7) |
| Creatinine | |
| >176.8 μmol/L | 0 (0.0) |
| BUN | |
| >14.28 mmol/L | 0 (0.0) |
| Sodium | |
| <130 mmol/L | 0 (0.0) |
Abbreviation: BUN, serum urea nitrogen. Values are presented as number (percentage).