Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-02

Study Completion Date

2021-11-05

Brief Summary

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This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).

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Detailed Description

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This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs.

Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2).

The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.

Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1 - Adult HFrEF patients

adult HFrEF patients who newly initiated sacubitril/valsartan

sacubitril/valsartan

Intervention Type DRUG

Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).

Cohort 2 - Adult CHF patients

adult CHF patients who newly initiated sacubitril/valsartan

sacubitril/valsartan

Intervention Type DRUG

Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).

Interventions

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sacubitril/valsartan

Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Cohort 1 - Adult HFrEF patients

* Newly initiated sacubitril/valsartan during the cohort identification period;
* Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
* That are ≥ 18 years old at index date;
* That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
* That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed.

Cohort 2 - Adult CHF patients

* Newly initiated sacubitril/valsartan during the cohort identification period;
* Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
* That are ≥ 18 years old at index date;
* That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
* That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of \<45 days allowed.