Table 3.
Adverse Event Rates in PARADIGM-HF, PIONEER-HF and TRANSITION
| Adverse Event | PARADIGM-HF | PIONEER-HF | TRANSITION | |||||
|---|---|---|---|---|---|---|---|---|
| Sacubitril-Valsartan | Enalapril | P | Sacubitril-Valsartan | Enalapril | P | Sacubitril-Valsartan | ||
| Symptomatic hypotension | 14.0% | 9.2% | <0.001 | 15.0% | 12.7% | NS | 11.1% | |
| Discontinuation due to symptomatic hypotension | 0.9% | 0.7% | 0.38 | 2.5% | 2.5% | NS | 1.4% | |
| Worsening renal functiona | 3.3% | 4.5% | 0.007 | 13.6% | 14.7% | NS | 4.1% | |
| Hyperkalaemiab | 4.3% | 5.6% | 0.007 | 11.6% | 9.3% | NS | 11.3% | |
| Cough | 11.3% | 14.3% | <0.001 | 0.7% | 0.2% | NR | 2.2% | |
| Angio-oedema | 0.4% | 0.2% | NS | 0.2% | 1.4% | NS | 0.3% | |
Notes: aSerum creatinine ≥221 µmmol/L in PARADIGM-HF and serum creatine rise of >44 µmol/L and a decrease in estimated glomerular filtration rate of >25% in PIONEER-HF; bSerum potassium >6.0 mmol/L; NR – not reported; NS – not significant.