European real-world patients prescribed sacubitril-valsartan for HFrEF had less ischaemic aetiology (OR 0.76; 95% CI 0.64-0.91) and were older than the PARADIGM-HF trial population.
Meta-Analysis (n=16,952)
Yes
Real-world European patients prescribed sacubitril-valsartan differ significantly from the PARADIGM-HF trial population, being older with more severe heart failure and achieving target doses less frequently.
Effect estimate: OR 0.76 (95% CI 0.64-0.91)
AIMS: We systematically reviewed the European real-world evidence (RWE) about sacubitril-valsartan for heart failure with reduced ejection fraction. METHODS AND RESULTS: Twenty-one articles, including 16 952 subjects, were identified until 31 October 2020. Taking as reference the PARADIGM-HF cohort, few baseline characteristics were presented in >80% of these studies, most often with high heterogeneity. In random-effects model meta-analysis, age was higher (mean difference +3.84, 95% CI 1.92-5.76), ischaemic aetiology (OR 0.76, 95% CI 0.64-0.91), hypertension (OR 0.55, 95% CI 0.37-0.82), and diabetes (OR 0.77, 95% CI 0.64-0.92) were less common, and the use of mineralocorticoid receptor antagonists was more frequent (OR 3.54, 95% CI 2.27-5.53) in real-life than in PARADIGM-HF. Other clinical and medical features were presented in 19-76% of the selected publications and suggested more severe heart failure with reduced ejection fraction. Sacubitril-valsartan was titrated to 97/103 mg b.i.d. in 35% (95% CI 23-47) and discontinued in 12.8% (95% CI 7.4-18.3) patients. When reported, the incidence of hyperkalaemia (six studies, no. 1076), all-cause mortality (five studies, no. 684), and any hospitalization (three studies, no. 390) was 12 (95% CI 5-19)/100 person-year, 8 (95% CI 4-12)/100 person-year, and 24 (95% CI 5-42)/100 person-year, respectively. Knowledge contribution, a metric measuring the proportion of RWE provided by each article based on the number of reported variables and the sample size, was 58.8% and 13.6% for the two biggest investigations (12 082 and 2037 patients), and <5% for all others (most with <100 subjects). CONCLUSIONS: Limited-quality RWE indicates that there are important differences between European patients prescribed sacubitril-valsartan and the PARADIGM-HF population, including the frequency of target dose achievement.
Giovinazzo et al. (Mon,) conducted a meta-analysis in heart failure with reduced ejection fraction (n=16,952). sacubitril-valsartan vs. PARADIGM-HF cohort was evaluated on ischaemic aetiology (OR 0.76, 95% CI 0.64-0.91). European real-world patients prescribed sacubitril-valsartan for HFrEF had less ischaemic aetiology (OR 0.76; 95% CI 0.64-0.91) and were older than the PARADIGM-HF trial population.