Key result
Sacubitril/valsartan target dose was reached by 45.2% of HFrEF patients, with HF-related hospitalization occurring in 19% of persistent vs 23.9% of non-persistent patients (P=0.405).
Why the study?
Despite clear ESC guidelines for heart failure, real-world evidence regarding the effectiveness, adherence, and persistence of drug therapy remains constantly needed.
What are the real-world pharmacoutilization, adherence, and persistence rates of sacubitril/valsartan in patients with HFrEF?
Cohort (n=948)
Yes
What are the real-world pharmacoutilization, adherence, and persistence rates of sacubitril/valsartan in patients with HFrEF?
Absolute Event Rate: 19% vs 23.9%
p-value: p=0.405
Modest adherence (53% full) and persistence seen in Italian HFrEF practice; leaves open how to optimize sacubitril/valsartan use outside trials.
AIMS: The current European Society of Cardiology (ESC) guidelines provide clear indications for the treatment of acute and chronic heart failure (HF). Nevertheless, there is a constant need for real-world evidence regarding the effectiveness, adherence, and persistence of drug therapy. We investigated the use of sacubitril/valsartan for the treatment of HF with reduced ejection fraction in real-world clinical practice in Italy. METHODS AND RESULTS: An observational, retrospective, non-interventional cohort study based on electronic medical records from nine specialized hospital HF centres in Italy was carried out on patients with prescription of sacubitril/valsartan. Overall, 948 patients had a prescription of sacubitril/valsartan, with 924 characterized over 6 months and followed up for 12 months. Pharmacoutilization data at 1 year of follow-up were available for 225 patients {mean age 69.7 years [standard deviation (SD) = 10.8], 81.8% male}. Of those, 398 (45.2%) reached the target dose of sacubitril/valsartan of 97/103 mg in a mean time of 6.9 (SD = 6.2) weeks. Blood pressure and hypotension in 61 patients (65%) and worsening of chronic kidney disease in 10 patients (10.6%) were the main reasons for not reaching the target dose. Approximatively 50% of patients had a change in sacubitril/valsartan dose during follow-up, and 158 (70.2%) were persistent with the treatment during the last 3 months of follow-up. A sensitivity analysis (persistence during the last 4 months of follow-up) showed persistence for 162 patients (72.0%). Adherence data, available for 387 patients, showed full adherence for 205 (53%). Discontinuation (102/717 patients, 14.2%) was mainly due to hypotension and occurred after a mean time of 34.3 (SD = 28.7) weeks. During follow-up, out of 606 patients with available data, 434 patients (71.6%) had an HF add-on drug or drugs concomitant with sacubitril/valsartan. HF-related hospitalization during follow-up was numerically higher in non-persistent (16/67 patients, 23.9%) vs. patients persistent to sacubitril/valsartan (30/158, 19%) (P = 0.405). CONCLUSIONS: Real-world data on the use of sacubitril/valsartan in clinical practice in Italy show a rapid titration to the target dose, high therapeutic adherence enabling a good level of therapeutic management in line with ESC guidelines for patients with reduced ejection fraction.
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Iacoviello et al. (2023) conducted a cohort in Heart failure with reduced ejection fraction (HFrEF) (n=948). Sacubitril/valsartan vs. Non-persistent patients was evaluated on HF-related hospitalization (p=0.405). Sacubitril/valsartan target dose was reached by 45.2% of HFrEF patients, with HF-related hospitalization occurring in 19% of persistent vs 23.9% of non-persistent patients (P=0.405).
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