Abstract
Determining if a medication is effective should be easy: Either the condition is or
is not improved. However, the truth is often more complex than that, including in
the antiarrhythmic drug (AAD) management of atrial fibrillation. In clinical trials,
AAD efficacy is usually determined by the time to first atrial fibrillation recurrence.
Another AAD efficacy endpoint, in patients with cardiac implantable electrical devices,
is a reduction of atrial fibrillation burden. Other cardiovascular outcomes have included
hospitalization, heart failure, and cardiovascular or total mortality. In clinical
practice AADs, for atrial fibrillation, are prescribed to reduce symptoms/improve
quality of life, which usually correlate with reduced atrial fibrillation frequency,
duration, and beneficial hemodynamic effects in certain patient subgroups. Time to
first recurrence is not a reliable predictor of clinical efficacy endpoints in practice.
This article presents a review for the practitioner of AAD efficacy endpoints in clinical
trials versus those in clinical practice and why such differences are present.
Keywords
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Article Info
Publication History
Published online: March 13, 2022
Footnotes
Funding: None.
Conflicts of Interest: JAR reports serving as investigator for Johnson & Johnson and Sanofi; as a consultant for Medtronic, Sanofi, Acesion, and Amarin; and as a speaker in programs supported by Sanofi. GVN reports serving as a consultant for Milestone, Sanofi, Acesion, Glaxo Smith Kline, ARCA, and Incarda Therapeutics.
Authorship: Both authors had access to the data and a role in writing this manuscript.
Identification
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