ENTRESTO®: A proven safety and tolerability profile in PARADIGM-HF
Because of the run-in design of the PARADIGM-HF trial, the adverse reaction rates in the randomized double-blind period of the trial may be lower than those expected to be seen in actual clinical practice.1†
Summary of adverse events of interest occurring in ≥5% of patients
in
the randomized,
double-blind
phase of PARADIGM-HF1†
| ADVERSE EVENTS |
ENTRESTO®
N=4,203 (%) |
Enalapril
N=4,229 (%) |
|---|---|---|
| Hypotension | 17.6 | 12.0 |
| Hyperkalemia | 11.6 | 14.0 |
| Renal impairment | 10.1 | 11.5 |
| Cough | 8.8 | 12.6 |
| Dizziness | 6.3 | 4.9 |
| Renal failure, including acute renal failure | 4.9 | 5.6 |
Adapted from the ENTRESTO® Product Monograph1
ENTRESTO®-treated patients who experienced a hypotensive event in the double-blind treatment phase were more commonly observed to have other associated hypotensive adverse events, compared to enalapril-treated patients, such as post-baseline systolic blood pressure (SBP) <90 mmHg (5.2% vs. 3.1%, respectively), a drop ≥30 mmHg in SBP from baseline (5.4% vs. 3.2%), and simultaneous symptomatic hypotension and SBP <90 mmHg (2.8% vs. 1.5%).
trial occurred in 10.7% of ENTRESTO®-treated patients vs. 12.2% of enalapril-treated patients.1†
| † | In the PARADIGM-HF trial, patients were required to complete sequential single-blind enalapril and ENTRESTO® run-in periods of a median duration of 15 and 29 days, respectively, prior to entering the randomized double-blind period, comparing ENTRESTO® and enalapril. During the enalapril run-in period,1,102 patients (10.5%) were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the ENTRESTO® run-in period, which followed the enalapril run-in phase, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%). |