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.
Study Type
OBSERVATIONAL
Enrollment
268
There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.
Novartis Investigational Site
Mumbai, India
Age information
Age information was reported
Time frame: Index date
Gender information
Gender information was reported
Time frame: Index date
Number of participants by Geographic area
Geographic area divided into 4 zones- North, South, East and West
Time frame: 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.
Time frame: index date
Body Mass Index
Median value body mass index was reported
Time frame: Index date
Classification of Heart Failure by etiology
Coronary artery disease, valvular, rheumatic heart disease, others, unknown.
Time frame: 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).
Time frame: Index date, 1.5 years
Medical History
type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction
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Time frame: 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
Time frame: Baseline, 1.5 years
Number of Hospitalizations
Hospitalizations due to cardiovascular and non-cardiovascular causes
Time frame: 1.5 years
Number of participants with concomitant medications
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.
Time frame: 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).
Time frame: 1.5 years
Persistence to sacubitril/valsartan
Defined as time duration from initiation to discontinuation of therapy.
Time frame: Up to 12 months post index date
Proportion of patient discontinuing sacubitril/valsartan
Reported as frequency (n) and percentage (%).
Time frame: 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
Time frame: 6 months post index date
Time to first dose up-titration
Median time to first dose up-titration
Time frame: 6 months post index date
Time to target dose
Median time to target dose
Time frame: 6 months post index date
Individual dose
The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg
Time frame: 6 months post index date
Titration patterns
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.
Time frame: 1.5 years
Proportion of patients being titrated to 100mg from 50mg
Proportion of patients being titrated to 100mg from 50mg
Time frame: 1.5 years
Proportion of patients being titrated to 200mg from 100mg
Proportion of patients being titrated to 200mg from 100mg
Time frame: 1.5 years