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Quantitative Assessments of the Impact of Nitrosamine Impurity and ARB Recall on ARB Utilization: A Multinational Study Protocol

Basic Details
Date Posted
Status
Complete
Medical Product
angiotensin II receptor blocker (ARB)
Description

This purpose of the Quantitative Assessments of the Impact of Nitrosamine Impurity and ARB Recall on ARB Utilization: A Multinational Study Protocol is to examine the response of patients and prescribers to the July 2018 recall of angiotensin receptor blockers (ARBs) with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities initiated by FDA and international regulatory agencies. The protocol seeks to query several systems using the Sentinel Common Data Model (SCDM), including FDA’s Sentinel System, the United Kingdom’s Clinical Practice Research Datalink (CPRD), the Canadian Network for Observational Drug Effect Studies (CNODES), and the Danish National Prescription Database (DNPR). The study aims to:

  1. Estimate the proportion of individual angiotensin receptor blocker (ARB)-containing product use over time
  2. Estimate the proportion of patients who switched from a primary ARB to another individual ARB over time
  3. Estimate the number of patients exposed to ARB with nitrosamine impurity
  4. Examine the proportion of patients who switched from ARB products with impurity to ARBs without impurity or other antihypertensives and to estimate the duration of ARB with impurity use prior to switching among patients who switch or end of treatment
Deliverable(s) (4)
Sentinel Drug Analysis: Valsartan and Non-Valsartan Angiotensin Receptor Blocker Utilization in the United States Following Recalls Due to Nitrosamine Impurities: A Descriptive Analysis Sentinel Drug Analysis: Valsartan and Non-Valsartan Angiotensin Receptor Blocker Utilization in Canada Following Recalls Due to Nitrosamine Impurities: A Descriptive Analysis Sentinel Drug Analysis: Valsartan and Non-Valsartan Angiotensin Receptor Blocker Utilization in Denmark Following Recalls Due to Nitrosamine Impurities: A Descriptive Analysis Sentinel Drug Analysis: Valsartan and Non-Valsartan Angiotensin Receptor Blocker Utilization in the United Kingdom Following Recalls Due to Nitrosamine Impurities: A Descriptive Analysis
Information
Population / Cohort
Individuals 18 years of age and older
Data Source(s)
Sentinel Distributed Database (SDD), Clinical Practice Research Datalink (CPRD) Aurum, Canadian Network for Observational Drug Effect Studies (CNODES), Danish National Prescription Registry (DNPR)
Workgroup Leader(s)

Michael Nguyen, MD; Efe Eworuke, PhD, MSc; Marie Bradley, PhD, MScPH, MPharm; 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)

Lee Hana, 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, Msc; 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, MPH; 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