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Journal of General Internal Medicine
Published in: Journal of General Internal Medicine 6/2018

01-06-2018 | Concise Research Reports

Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety

Authors: Michael Fralick, MD, MSc, Jerry Avorn, MD, Jessica M. Franklin, PhD, Emily Bartsch, BMSc, Abdurrahman Abdurrob, BS, Aaron S. Kesselheim, MD, JD, MPH

Published in: Journal of General Internal Medicine | Issue 6/2018

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Excerpt

Some randomized controlled trials (RCTs) include a pre-randomization run-in phase.1 During this phase, eligible patients are typically administered a drug or placebo to exclude non-adherent patients, placebo responders, or patients who do not respond to or tolerate the active drug prior to trial initiation.1,2 Our review of DPP4 inhibitors found that trials with run-in phases provided findings of efficacy and safety similar to those seen in trials of the same medications without run-in phases.3 We sought to determine if this observation also applied to statin medications. …
Literature
1.
Pablos-Méndez A, Barr RG, Shea S. Run-in periods in randomized trials: implications for the application of results in clinical practice. JAMA. 1998;279(3):222–225.CrossRef
2.
Rothwell PM. Factors that can affect the external validity of randomised controlled trials. PLoS Clin Trials. 2006;1(1):e9.CrossRef
3.
Fralick M, Avorn J, Franklin JM, Abdurrahman A, Kesselheim AS. Application and impact of run-in studies. JGIM. 2018.
4.
Chou R, Dana T, Blazina I, Daeges M, Jeanne TL. Statins for prevention of cardiovascular disease in adults. JAMA. 2016;316(19):2008–2024.CrossRef
5.
Dersimonian R, Laird N. Meta-analysis in clinical trials. Stat Med. 1986;188:177–188.
Metadata
Title
Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety
Authors
Michael Fralick, MD, MSc
Jerry Avorn, MD
Jessica M. Franklin, PhD
Emily Bartsch, BMSc
Abdurrahman Abdurrob, BS
Aaron S. Kesselheim, MD, JD, MPH
Publication date
01-06-2018
Publisher
Springer US
Published in
Journal of General Internal Medicine / Issue 6/2018
Print ISSN: 0884-8734
Electronic ISSN: 1525-1497
DOI
https://doi.org/10.1007/s11606-018-4349-2

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