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Utilization of Valsartan: A Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
valsartan
Description

In this analysis, we estimated rates of valsartan utilization and patient follow‐up time, by N‐nitrosodimethylamine (NDMA) contamination categories. We additionally summarized the cumulative exposed duration and cumulative exposed dose for valsartan products by NDMA contamination categories in the Sentinel Distributed Database (SDD). We distributed this request to six Sentinel Data Partners on June 23, 2023. This analysis includes two reports:

  • Report 1: contains data from a subset of five Sentinel Data Partners, including the nationally‐representative commercial insurers and Medicare. The study period includes data from May 1, 2012 to December 31, 2022.
  • Report 2: contains data from one Sentinel Data Partner, Medicaid. The study period includes data from May 1, 2012 to December 31, 2018.
Deliverables (2)
Sentinel Modular Program Report: Utilization of Valsartan: A Descriptive Analysis, Report 1 Sentinel Modular Program Report: Utilization of Valsartan: A Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
May 1, 2012 - December 31, 2022; May 1, 2012 - December 31, 2018
Analysis Type
Descriptive
Population / Cohort
Individuals 18 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Publication: Valsartan, Losartan and Irbesartan Use in the USA, UK, Canada and Denmark After the Nitrosamine Recalls: A Descriptive Cohort Study
Publication: Exposure to Valsartan Products Containing Nitrosamine Impurities in the United States, Canada, and Denmark
Presentation: Impact of Nitrosamine Contamination Recalls on Angiotensin-Receptor-Blocker (ARB) Utilization in the U.S., U.K., Canada, and Denmark
Presentation: Exposure to N-nitrosodimethylamine (NDMA)/N-nitrosodiethylamine (NDEA)-contaminated Angiotensin-II Receptor Blockers Products in the United States
Sentinel Drug Analysis: N‐nitrosodimethylamine (NDMA)‐Contaminated and Non‐NDMA‐Contaminated Valsartan Use: A Descriptive Analysis
Sentinel Drug Analysis: Use of Valsartan, Angiotensin II Receptor Blockers (ARB), and Angiotensin-Converting Enzyme (ACE) Inhibitors
Sentinel Drug Analysis: Incidence and Prevalence of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) Contaminated Valsartan Use: A Descriptive Analysis