Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 1, 2022

Detailed Description

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.

Interventions

  • Drug: sacubitril/valsartan
    • There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.

Arms, Groups and Cohorts

  • sacubitril/valsartan
    • Patients administered sacubitril/valsartan by prescription

Clinical Trial Outcome Measures

Primary Measures

  • Age information
    • Time Frame: Index date
    • Age information was reported
  • Gender information
    • Time Frame: Index date
    • Gender information was reported
  • Number of participants by Geographic area
    • Time Frame: idex date
    • Geographic area divided into 4 zones- North, South, East and West
  • Functional Class (New York Heart Association (NYHA) classification)
    • Time Frame: index date
    • 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.
  • Body Mass Index
    • Time Frame: Index date
    • Median value body mass index was reported
  • Classification of Heart Failure by etiology
    • Time Frame: 1.5 years
    • Coronary artery disease, valvular, rheumatic heart disease, others, unknown.
  • Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)
    • Time Frame: Index date, 1.5 years
    • An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat).
  • Medical History
    • Time Frame: 1.5 years
    • type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction
  • Number of participants with notable changes in laboratory parameters
    • Time Frame: Baseline, 1.5 years
    • Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline
  • Number of Hospitalizations
    • Time Frame: 1.5 years
    • Hospitalizations due to cardiovascular and non-cardiovascular causes
  • Number of participants with concomitant medications
    • Time Frame: up to 6 months pre index date, Up to 6 months post index date
    • Concomitant medications classified as- Medications for HF: Diuretics, digitalis, beta-Blockers, ACEi, ARBs, MRA, ivabradine, SGLT2 inhibitors. Medications for non-HF conditions: Anti-diabetic medications other than SGLT2 inhibitors (oral and injectable), statin, antiplatelet therapy, oral anti-coagulants.
  • Number of patients with other treatments for heart failure
    • Time Frame: 1.5 years
    • Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).

Secondary Measures

  • Persistence to sacubitril/valsartan
    • Time Frame: Up to 12 months post index date
    • Defined as time duration from initiation to discontinuation of therapy.
  • Proportion of patient discontinuing sacubitril/valsartan
    • Time Frame: month 2, month 4, month 6, month 8 and month 12
    • Reported as frequency (n) and percentage (%).
  • Maximum individual dose reached
    • Time Frame: 6 months post index date
    • Median value of maximum individual dose reached will be reported
  • Time to first dose up-titration
    • Time Frame: 6 months post index date
    • Median time to first dose up-titration
  • Time to target dose
    • Time Frame: 6 months post index date
    • Median time to target dose
  • Individual dose
    • Time Frame: 6 months post index date
    • The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg
  • Titration patterns
    • Time Frame: 1.5 years
    • Listings for all titration patterns which evaluated longitudinally at the patient level as follows: Up-titration’ corresponds to all patients who experience an initial increase in sacubitril/valsartan dose post-index, ‘Stable up-titration’ corresponds to up-titrated patients who experience no subsequent decrease in sacubitril/valsartan dose ‘Down-titration’ corresponds to all patients who experience an initial dose decrease in sacubitril/valsartan dose post-index, and ‘Stable down-titration’ corresponds to the proportion of down-titrated patients who experience no subsequent up-titration.
  • Proportion of patients being titrated to 100mg from 50mg
    • Time Frame: 1.5 years
    • Proportion of patients being titrated to 100mg from 50mg
  • Proportion of patients being titrated to 200mg from 100mg
    • Time Frame: 1.5 years
    • Proportion of patients being titrated to 200mg from 100mg

Participating in This Clinical Trial

Inclusion Criteria

  • Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at or before the index date – A prescription of sacubitril/valsartan Exclusion Criteria:

  • Diagnosis of HF specified as preserved/mid-range ejection fraction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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