Table 2.
Number and rate of cognition‐related adverse events in trials analysed
| Broad SMQ n (ratea) | Narrow SMQ n (ratea) | |
|---|---|---|
| PARADIGM‐HF | ||
| Enalapril (n = 4212) | 97 (0.91, 0.73–1.12) | 15 (0.16, 0.10–0.27) |
| Sacubitril/valsartan (n = 4187) | 104 (0.92, 0.75–1.14) | 12 (0.12, 0.07–0.21) |
| Hazard ratio (95% CI) | 1.01 (0.75–1.37) | 0.73 (0.33–1.59) |
| Val‐HeFT | ||
| Placebo (n = 2494) | 139 (3.03, 2.57–3.56) | 5 (0.11, 0.04–0.26) |
| Valsartan (n = 2506) | 102 (2.20, 1.82–2.67) | 6 (0.13, 0.06–0.28) |
| Hazard ratio (95% CI) | 0.73 (0.56–0.94) | 1.12 (0.37–3.93) |
| CORONA | ||
| Placebo (n = 2497) | 115 (1.62, 1.33–1.97) | 19 (0.31, 0.20–0.48) |
| Rosuvastatin (n = 2514) | 120 (1.74, 1.44–2.10) | 28 (0.45, 0.31–0.65) |
| Hazard ratio (95% CI) | 1.07 (0.82–1.41) | 1.46 (0.82–2.62) |
| ATMOSPHERE | ||
| Enalapril (n = 2336) | 52 (0.65, 0.48–0.85) | 17 (0.21, 0.12–0.33) |
| Aliskiren (n = 2340) | 81 (1.01,0.81–1.26) | 20 (0.25, 0.15–0.38) |
| Combination (n = 2340) | 85 (1.05, 0.84–1.30) | 16 (0.20, 0.11–0.32) |
| Hazard ratio (95% CI)b | 1.57 (1.11–2.22) | 1.18 (0.62–2.26) |
| Hazard ratio (95% CI)c | 1.63 (1.15–2.30) | 0.93 (0.47–1.85) |
CI, confidence interval; SMQ, Standardized Medical Dictionary for Regulatory Activities Query.
a
Rates were calculated per 100 patient‐years (crude rate with 95% confidence interval). Rate for broad SMQ includes narrow SMQ terms.
b
Aliskiren vs. enalapril.
c
Combination vs. enalapril.