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Spironolactone Use in Patients with Reduced Ejection Fraction Heart Failure (HFrEF) or Preserved Ejection Fraction Heart Failure (HFpEF)

Basic Details
Date Posted
Status
Complete
Medical Product
spironolactone
Description

In this report we examined the number of individuals with reduced ejection fraction heart failure (HFrEF) or preserved ejection fraction heart failure (HFpEF) in the Sentinel Distributed Database (SDD) and described the utilization of spironolactone among these individuals.

The study period included data from July 1, 2010 to September 30, 2018. We distributed the request to 16 Data Partners on February 13, 2020.

Deliverables (1)
Sentinel Modular Program Report: Spironolactone Use in Patients with Reduced Ejection Fraction Heart Failure (HFrEF) or Preserved Ejection Fraction Heart Failure (HFpEF)
Additional Details
FDA Center
CDER
Time Period
July 1, 2010 - September 30, 2018
Analysis Type
Descriptive
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
ICPE 2020: Utilization of Spironolactone in Patients with Reduced or Preserved Ejection Fraction Heart Failure
Sentinel Drug Study: Aldactone (spironolactone) & Indications for Use