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Pharmacoutilization and adherence to sacubitril/valsartan in real world: the REAL.IT study in HFrEF
Massimo Iacoviello1, Gabriele Di Gesaro2, Filippo Maria Sarullo3
1Surgical and Medical Sciences Department, University of Foggia, Foggia, Italy.
Insights
Real-world use of sacubitril/valsartan in Italy demonstrated rapid titration to target doses and high adherence in heart failure patients. This effective management aligns with European Society of Cardiology guidelines for reduced ejection fraction.
Area of Science:
- Cardiology
- Pharmacology
- Real-world evidence studies
Background:
- European Society of Cardiology (ESC) guidelines offer clear indications for heart failure (HF) treatment.
- Real-world data on drug effectiveness, adherence, and persistence are crucial for optimizing HF management.
- Sacubitril/valsartan is a key therapy for HF with reduced ejection fraction (HFrEF).
Purpose of the Study:
- To investigate the real-world utilization, effectiveness, adherence, and persistence of sacubitril/valsartan in HFrEF patients in Italy.
- To assess the achievement of target doses and identify reasons for dose modification or discontinuation.
Main Methods:
- Observational, retrospective, non-interventional cohort study utilizing electronic medical records from nine Italian hospital HF centers.
- Analysis of 948 patients prescribed sacubitril/valsartan, with detailed follow-up for 924 patients over 12 months.
- Evaluation of pharmacoutilization, dose titration, adherence, persistence, and HF-related hospitalizations.
Main Results:
- 45.2% of patients reached the target dose of sacubitril/valsartan (97/103 mg) within a mean of 6.9 weeks; main barriers were blood pressure issues and worsening kidney disease.
- Approximately 50% experienced dose changes; 70.2% were persistent with treatment over 12 months. Full adherence was observed in 53% of patients.
- Hypotension was the primary reason for discontinuation (14.2%). Numerically higher HF hospitalizations were noted in non-persistent patients.
Conclusions:
- Real-world data from Italy indicate effective and rapid titration of sacubitril/valsartan in HFrEF patients.
- High therapeutic adherence and persistence support good treatment management consistent with ESC guidelines.
- The study highlights the feasibility of optimizing sacubitril/valsartan therapy in routine clinical practice.
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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