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Canadian Journal of Cardiology

EFFECTIVENESS, SAFETY, AND TOLERABILITY OF SACUBITRIL/VALSARTAN OVER 3 YEARS OF FOLLOW-UP IN CANADIAN PRACTICE: INSIGHTS FROM THE PARTHENON REGISTRY

      Background

      The PARADIGM-HF trial demonstrated the superiority of sacubitril/valsartan over enalapril in reducing the risk of CV death or HF hospitalization in patients with HFrEF. The generalisability of these data as well as safety and medication persistence to unselected, real world patients remained to be evaluated. The PARTHENON (PAtient RegisTry assessing effectiveness and safety of HEart failure treatment with LCZ696 acrOss CaNada) registry study was conducted to evaluate the effects of sacubitril/valsartan use in Canadian patients with HFrEF.

      Methods and Results

      PARTHENON was an observational, naturalistic, multi-centre study of Canadian patients with HFrEF who were initiated on sacubitril/valsartan as per the Canadian label within 3 months prior to study start. Over a 3-year period, 996 patients from 32 community and academic centres across 7 provinces were followed. Total daily dosage of sacubitril/valsartan at initiation and at each annual timepoint are shown in Figure 1. At baseline, most (699/996; 70.2%) were initiated on 100 mg daily. By 12 months, 47.5% of patients (n=401/844) were at the maximum daily dosage of 400 mg, with 26.3% of patients receiving 200 mg daily, and 20.4% receiving 100 mg daily. The observed 3-year all-cause mortality rate was 10.8%, which was lower than the 3-year all-cause mortality rate of 29.0 ± 13.7% predicted by the MAGGIC risk score; the projected 3-year survival rate of 53.4 ± 26.4% from the Seattle Heart Failure Model was also lower than the observed 89.2% survival rate. Several a priori defined secondary safety-related endpoints are summarized in Table 1. For patients who experienced an AE, 354 (35.5%) were suspected by the investigator to be related to sacubitril/valsartan, and 103 (10.3%) patients were withdrawn from sacubitril/valsartan due to an AE.

      Conclusion

      The PARTHENON registry confirms the safety and tolerability of long-term administration of sacubitril/valsartan in a real-world setting, additionally demonstrating favourable survival in eligible patients with HFrEF compared to predicted survival.
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