Quantitative Assessment of the Impact of Nitrosamine Contamination and Angiotensin Receptor Blockers (ARB) Recall on ARB Utilization: A Multinational Study

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Details

Basic Details

Date Posted:

Tuesday, August 18, 2020

Status:

In progress

Medical Product:

angiotensin II receptor blocker (ARB), angiotensin receptor blocker, angiotensin-converting enzyme (ACE) inhibitor, calcium channel blockers (CCB)

Description:

The purpose of this international descriptive study is to examine changes in ARB utilization suspected to have resulted from the July 2018 recall of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) contaminated angiotensin receptor blockers (ARBs) initiated by FDA and international regulatory agencies. The project seeks to query several data sources using the Sentinel Common Data Model (SCDM). The FDA will conduct US based analyses in their Sentinel System. The international participants will conduct the same analyses in their data sources which include: United Kingdom (Clinical Practice Research Datalink (CPRD)), Canada (Canadian Network for Observational Drug Effect Studies (CNODES)), Denmark (Danish National Prescription Database (DNPR)). The study aims to:

Estimate the proportion of individual ARB-containing product use over time
Estimate the proportion of patients who switched from a primary ARB to another individual ARBs, angiotension-converting enzyme (ACE) inhibitors or calcium channel blockers (CCB) over time
Estimate the number of patients exposed to contaminated ARBs
Examine the proportion of patients who switched from contaminated ARBs to non-contaminated ARBs or other antihypertensives and to estimate the duration of contaminated ARB use prior to switching among patients who switch or end of treatment

Additional Information

Information

Time Period:

January 1, 2014 - Latest Possible Date

Population / Cohort:

Individuals at least 18 years of age who received a prescription or dispensing for an ARB product.

Data Source(s):

Sentinel will query all Sentinel Data Partners. International collaborators will use: Clinical Practice Research Datalink (CPRD) Aurum, Canadian Network for Observational Drug Effect Studies (CNODES), Danish National Prescription Registry (DNPR).

Contributors

Workgroup Leader(s):

Efe Eworuke, PhD, MSc; Marie Bradley, PhD, MScPH, MPharm; Michael Nguyen, MD; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA

Judith C. Maro, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA

Workgroup Member(s):

Hana Lee, PhD; Dinci Pennap, PhD; Daniel Woronow, MD; US Food and Drug Administration, Silver Spring, MD, USA

Christopher Gravel, PhD, MSc; Health Canada, Ottawa, ON, CA

Robert Platt, PhD, MSc; Carolina Moriello, Mc; Michael Paterson; C. Fangyun Wu, MSc, MA; Canadian Network for Observational Studies, Toronto, ON, CA

Rebecca Ghosh, MD; Puja Myles, PhD, MPH; Stephan Welburn, PhD; Clinical Practice Research Data Link, London, UK

Peter Bjødstrup Jensen, PhD; Anton Pottegård, MScPharm, PhD, DMSc; Danish National Prescription Registry, Odense, DK

Mayura Shinde, PhD; Sampada Nandyala, MPH; Daniel Scarnecchia, MPIA; Emily Welch, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA

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Quantitative Assessment of the Impact of Nitrosamine Contamination and Angiotensin Receptor Blockers (ARB) Recall on ARB Utilization: A Multinational Study

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