A Cohort Study to Compare the Hospitalization Between Naive Sacubitril/Valsartan and Naive ACEi/ARBs Heart Failure Patients With Reduced Ejection Fraction Using Secondary US Electronic Health Records Data

Novartis

Status

Completed

Conditions

Heart Failure

Treatments

Drug: Sacubitril/valsartan

Drug: ACEi/ARB

Study type

Observational

Funder types

Industry

Identifiers

NCT05096143

CLCZ696B2036

Details and patient eligibility

About

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.

Full 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

Enrollment

42,269 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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