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.
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
Study Type
OBSERVATIONAL
Enrollment
42,269
Participants who were prescribed with Sacubitril/valsartan
Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
Novartis Investigative Site
East Hanover, New Jersey, United States
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
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 frame: through study completion, maximum 5 years
Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB HFrEF patients
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 frame: through study completion, maximum 5 years
Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
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 frame: through study completion, maximum 5 years
Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
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.
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Time frame: through study completion, maximum 5 years
Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
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 frame: through study completion, maximum 5 years
Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period.
Time frame: through study completion, maximum 5 years
Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period.
Time frame: through study completion, maximum 5 years
Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
The rate of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients was reported
Time frame: through study completion, maximum 5 years