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This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded.
Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sacubitril/valsartan | Patients administered sacubitril/valsartan by prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacubitril/valsartan | Drug | There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Age information | Age information was reported | Index date |
| Gender information | Gender information was reported | Index date |
| Number of participants by Geographic area | Geographic area divided into 4 zones- North, South, East and West | idex date |
| Functional Class (New York Heart Association (NYHA) classification) | The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. | index date |
| Body Mass Index | Median value body mass index was reported | Index date |
| Classification of Heart Failure by etiology | Coronary artery disease, valvular, rheumatic heart disease, others, unknown. | 1.5 years |
| Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF) | An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat). | Index date, 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence to sacubitril/valsartan | Defined as time duration from initiation to discontinuation of therapy. | Up to 12 months post index date |
| Proportion of patient discontinuing sacubitril/valsartan |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at index date with a prescription of sacubitril/valsartan
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Mumbai | India |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| Medical History | type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction | 1.5 years |
| Number of participants with notable changes in laboratory parameters | Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline | Baseline, 1.5 years |
| Number of Hospitalizations | Hospitalizations due to cardiovascular and non-cardiovascular causes | 1.5 years |
| Number of participants with concomitant medications | Concomitant medications classified as-
| up to 6 months pre index date, Up to 6 months post index date |
| Number of patients with other treatments for heart failure | Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT). | 1.5 years |
Reported as frequency (n) and percentage (%).
| month 2, month 4, month 6, month 8 and month 12 |
| Maximum individual dose reached | Median value of maximum individual dose reached will be reported | 6 months post index date |
| Time to first dose up-titration | Median time to first dose up-titration | 6 months post index date |
| Time to target dose | Median time to target dose | 6 months post index date |
| Individual dose | The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg | 6 months post index date |
| Titration patterns | Listings for all titration patterns which evaluated longitudinally at the patient level as follows:
| 1.5 years |
| Proportion of patients being titrated to 100mg from 50mg | Proportion of patients being titrated to 100mg from 50mg | 1.5 years |
| Proportion of patients being titrated to 200mg from 100mg | Proportion of patients being titrated to 200mg from 100mg | 1.5 years |