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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Naive Sacubitril/valsartan Participants who were prescribed with Naive Sacubitril/valsartan |
Drug: Sacubitril/valsartan
Participants who were prescribed with Sacubitril/valsartan
Other Names:
|
| Naive ACEi/ARB Participants who were prescribed with Naive Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB) |
Drug: ACEi/ARB
Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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.
- 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.
- 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
Eligibility Criteria
Criteria
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.
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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.
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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.
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That were ≥18 years old at index date.
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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.
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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.
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That were ≥ 18 years old at index date.
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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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | East Hanover | New Jersey | United States | 07936 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CLCZ696B2036