Heart Failure
Conditions
Keywords
Sacubritril-valsartan, Heart failure, Cardiovascular outcomes
Brief summary
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).
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Left ventricular ejection fraction (LVEF) \< 40% * Brain natriuretic peptide (BNP) ≥35 pg/mL or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥125 pg/mL * Had a record in the database in the 365 days prior to the index date
Exclusion criteria
* Missing sex or date of birth * Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 at SAC/VAL, ACEi or ARB initiation * History of angioedema or unacceptable side effects during receipt of SAC/VAL, ACEi or ARB * Severe hepatic impairment, biliary cirrhosis, and cholestasis * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization | 180 days, 810 days, 1260 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Hazard Ratio for First Hospitalization or Emergency Room Visit | 180 days, 810 days, 1260 days | Hospitalizations or emergency room visits for heart failure, and any cause were recorded. |
| 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 | 180 days, 810 days, 1260 days | Improved LVEF was defined as having at least one LVEF measurement equal or above 40% after having an LVEF under 40%. |
| 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 | Up to 5 years | Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams. |
| Number of Days Patients Were Absent From Work per Calendar Year | Up to 5 years | — |
| Healthcare Resource Utilization Costs per Patient per Year | Up to 5 years | Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams. |
| Hazard Ratio for Hyperkalemia | 180 days, 810 days, 1260 days | — |
| Rate of Dose Titration Events per 100-Person-Years | 180 days, 810 days, 1260 days | Rates were measured for dose titrations from: * low to medium * medium to low * medium to high * high to medium |
| 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 | Baseline | Demographics included age and sex. |
| Number of Patients by Clinical Characteristic Category | Baseline | Clinical characteristics included: * New York Heart Association (NYHA) Class * eGFR ≥ 60 mL/minute/1.73 m\^2 * eGFR \< 60 mL/minute/1.73 m\^2 * LVEF ≤ 35% * LVEF \> 35% * Type of medication * Comorbidities |
Countries
United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed