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This was a retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in northern Portugal. The study aimed to assess the comparative effectiveness of sacubitril/valsartan (SAC/VAL) versus angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) in patients with heart failure with reduced ejection fraction (HFrEF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAC/VAL Cohort | Adult patients with HFrEF undergoing therapy with SAC/VAL. | ||
| ACEi/ARB Cohort | Adult patients with HFrEF undergoing therapy with ACEi/ARB. | ||
| Missed Opportunities Cohort | Patients who were eligible for but did not receive SAC/VAL. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization | 180 days, 810 days, 1260 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hazard Ratio for Death From Cardiovascular Causes | 180 days, 810 days, 1260 days | |
| Hazard Ratio for Hospitalization for Heart Failure | 180 days, 810 days, 1260 days | |
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Inclusion criteria:
Exclusion criteria:
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The study included heart failure patients with reduced ejection fraction.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Hazard Ratio for First Hospitalization or Emergency Room Visit |
Hospitalizations or emergency room visits for heart failure, and any cause were recorded. |
| 180 days, 810 days, 1260 days |
| Hazard Ratio for First Cardiovascular-specific Hospitalization | 180 days, 810 days, 1260 days |
| Hazard Ratio for the Composite of Death From Cardiovascular Causes, Hospitalization for Heart Failure, Non-fatal Myocardial Infarction and Non-fatal Stroke | 180 days, 810 days, 1260 days |
| Hazard Ratio for Implantable Cardioverter-defibrillator (ICD) Procedure | 180 days, 810 days, 1260 days |
| Hazard Ratio for All-cause Mortality | 180 days, 810 days, 1260 days |
| Hazard Ratio for Improved LVEF | Improved LVEF was defined as having at least one LVEF measurement equal or above 40% after having an LVEF under 40%. | 180 days, 810 days, 1260 days |
| Pearson Correlation Coefficient Between Change From Baseline in NT-proBNP and LVEF | 180 days, 810 days, 1260 days |
| Change From Baseline in NT-proBNP | 180 days, 810 days, 1260 days |
| Change From Baseline in LVEF | 180 days, 810 days, 1260 days |
| Total Healthcare Resource Utilization Costs per Calendar Year | Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams. | Up to 5 years |
| Number of Days Patients Were Absent From Work per Calendar Year | Up to 5 years |
| Healthcare Resource Utilization Costs per Patient per Year | Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams. | Up to 5 years |
| Hazard Ratio for Hyperkalemia | 180 days, 810 days, 1260 days |
| Rate of Dose Titration Events per 100-Person-Years | Rates were measured for dose titrations from:
| 180 days, 810 days, 1260 days |
| Rate of Patients Reaching the Maximum Dose per 100-Person-Years | 180 days, 810 days, 1260 days |
| Rate of Treatment Discontinuation | 180 days, 810 days, 1260 days |
| Number of Patients by Demographic Category | Demographics included age and sex. | Baseline |
| Number of Patients by Clinical Characteristic Category | Clinical characteristics included:
| Baseline |