Publication details
Co nám přináší studie PARADIGM-HF
| Title in English | Conclusions of the PARADIGM-HF study |
|---|---|
| Authors | |
| Year of publication | 2014 |
| Type | Article in Periodical |
| Magazine / Source | Kardiologická revue - Interní medicína |
| MU Faculty or unit | |
| Citation | |
| Field | Cardiovascular diseases incl. cardiosurgery |
| Keywords | LCZ696; enalapril; heart failure |
| Description | PARADIGM-HF compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction. Methods: In this double-blind trial, 8442 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less were assigned to receive either LCZ696 (at a dose of 200 mg twice daily) or enalapril (at a dose of lOmg twice daily), in addition to the standard therapy. There were two primary outcomes - mortality from cardiovascular causes and hospitalisation for heart failure, but the trial was designed to detect the differences in the rates of mortality from cardiovascular causes. Results: In line with the pre-specified rules, the trial was stopped early, after a median follow-up of 27 months, because the boundary indicating a clear benefit achieved with LCZ696 had been exceeded. At the time of study closure, the primary outcome had occurred in 914 patients (21.8%) in the LCZ696 group and 1117 patients (26.5%) in the enalapril group (hazard ratio in the LCZ696 group, 0.80; 95% confidence interval [Cl], 0.73 to 0.87; P < 0.001). A total of 711 patients (17.0%) receiving LCZ696 and 835 patients (19.8%) receiving enalapril died (hazard ratio for death from any cause, 0.84; 95% Cl, 0.76 to 0.93; P < 0.001); of these patients, 558 (13.3%) and 693 (16.5%), respectively, died from cardiovascular causes (hazard ratio, 0.80; 95% Cl, 0.71 to 0.89; P < 0.001). As compared with enalapril, LCZ696 also reduced the risk of hospitalisation for heart failure by 21% (P < 0.001) and decreased the symptoms and physical limitations of heart failure (P = 0.001). The LCZ696 group showed higher proportions of patients with hypotension and non-serious angioedema but lower proportions of patients with renal impairment, hyperkalemia, and cough when compared to the enalapril group. Conclusions: LCZ696 was more effective than enalapril in reducing the risk of death and of hospitalisation for heart failure. |