Heart Failure
Conditions
Keywords
Heart failure hospitalizations,, sacubitril/valsartan,, Angiotensin II receptor antagonist,, United States,, electronic health record
Brief summary
A non-interventional retrospective cohort study conducted to compare the naive sacubitril/valsartan Heart Failure with reduced Ejection Fraction (HFrEF) patient population to a matched naive ACEi/ARB HFrEF patient population.
Detailed description
This was a non-interventional retrospective cohort study using the US secondary EHR dataset, Optum EHR, to compare the naive sacubitril/valsartan HFrEF patient population (aged ≥ 18 years) to a matched naive ACEi/ARB HFrEF patient population. The study comprised of the following periods: Identification period: 01-Jul-2015 to 31-Mar-2019 Study period * 01-Jul-2014 to 31-Mar-2020 for primary objective and secondary objective 2 to 6. * 01-Jul-2008 to 30-Sep-2020 for secondary objective 1. Follow-up period: Patients were followed up until 31-Mar-2020, death or patient transfer out. Baseline period: 365 days prior to index
Interventions
DRUGSacubitril/valsartan
Participants who were prescribed with Sacubitril/valsartan
DRUGACEi/ARB
Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Sacubitril/valsartan incident cohort Included patients * Prescribed sacubitril/valsartan within the identification period (01-July-2015 to 31-Mar-2019), that had non-missing gender and year of birth data. * With at least one ICD-9-CM or ICD-10-CM code for diagnosis of HF within one-year prior to date of first prescription of sacubitril/valsartan (index date), and are treated as part of the integrated delivery network. * With first month active 365 days prior to index and last date active was greater than or equal to (≥) index, and the month of provider source data was greater than the final date of patient follow-up. * That were ≥18 years old at index date. * With a valid LVEF value ≤40%, prior to index (index date included). Angiotensin-converting enzyme inhibitors (ACEi) and Angiotensin II receptor antagonist (ARB) incident cohort Included patient: * Prescribed ACEi or ARBs within the identification period (01-Jul-2015 to 31-Mar-2019), that had non-missing gender and year of birth data. * With at least one ICD-9-CM or ICD-10-CM code for diagnosis of HF within one-year prior to date of first prescription of ACEi or ARB (index date), and were treated as part of the integrated delivery network. * With first month active 365 days prior to index and last date active was ≥ index, and the month of provider source data is greater than the final date of patient follow-up. * That were ≥ 18 years old at index date. * With a valid LVEF value ≤ 40%, prior to index (index date included).
Exclusion criteria
Sacubitril/valsartan incident cohort Excluded patients for the primary objective and secondary objective 2 to 6: * Patients who were prescribed sacubitril/valsartan within one-year prior to index date. * Patients who were prescribed ACEi or ARBs, within one-year prior to index date (index date included). Exclude patients for secondary objective 1: * Patients who were prescribed sacubitril/valsartan prior to index date. * Patients who were prescribed ACEi or ARBs prior to index date (index date included). Angiotensin-converting enzyme inhibitors (ACEi) and Angiotensin II receptor antagonist (ARB) incident cohort Exclude patients for the primary objective and secondary objective 2 to 6: * Patients who were prescribed ACEi or ARBs within one-year prior to index date. * Patients who were prescribed sacubitril/valsartan within one-year prior to index date (index date included). * Which had a valid sacubitril/valsartan prescription that enables inclusion in the sacubitril/valsartan cohort. * Exclude patients for secondary objective 1: * Patients who were prescribed ACEi or ARBs prior to index date. * Patients who were prescribed sacubitril/valsartan prior to index date (index date included). * Which had a valid sacubitril/valsartan prescription that enables inclusion in the sacubitril/valsartan cohort
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Heart Failure (HF) hospitalizations events for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB Heart Failure with reduced Ejection Fraction (HFrEF) patients | through study completion, maximum 5 years | Heart failure hospitalizations were defined by ICD-9-CM (The International Classification of Diseases, 9th Revision, Clinical Modification) and ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modifier) codes for HF listed within the primary diagnoses associated with a hospitalization that occurred during the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | Heart failure hospitalizations were defined by ICD-9-CM (The International Classification of Diseases, 9th Revision, Clinical Modification) and ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modifier) codes for HF listed within the primary diagnoses associated with a hospitalization that occurred during the follow-up period. |
| Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | Heart failure hospitalizations were defined by ICD-9-CM (The International Classification of Diseases, 9th Revision, Clinical Modification) and ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modifier) codes for HF listed within the primary diagnoses associated with a hospitalization that occurred during the follow-up period. |
| Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | HF ER visits were defined by ICD-9-CM and ICD-10-CM codes for HF listed within the primary diagnoses associated with ER visits that occurred during the follow-up period. |
| Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period. |
| Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period. |
| Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | The rate of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients was reported |
| Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients | through study completion, maximum 5 years | HF ER visits were defined by ICD-9-CM and ICD-10-CM codes for HF listed within the primary diagnoses associated with ER visits that occurred during the follow-up period. |
Countries
United States
Outcome results
None listed