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

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:

  1. Estimate the proportion of individual ARB-containing product use over time
  2. 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
  3. Estimate the number of patients exposed to contaminated ARBs
  4. 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
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).
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; Melissa Kampman, PhD, MSc; Health Canada, Ottawa, ON, CA

Stine Hasling Mogensen, PhD, DKMA Analytics Centre, Danish Medicines Agency, Copenhagen, Denmark

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; University of Southern Denmark, Odense, DK

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

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