Format

Send to

Choose Destination
See comment in PubMed Commons below
Expert Opin Drug Saf. 2012 Mar;11(2):191-214. doi: 10.1517/14740338.2012.660915. Epub 2012 Feb 13.

Examining the safety of amiodarone.

Author information

1
St. David's Medical Center, Texas Cardiac Arrhythmia Institute, Austin, USA.

Abstract

INTRODUCTION:

Amiodarone is the most widely used antiarrhythmic agent, with demonstrated effectiveness against all the spectrum of cardiac tachyarrhythmias. The risk of adverse effects acts as a limiting factor to its utilization especially in the long term. This article systematically reviews the published evidence on amiodarone versus placebo to examine its safety as an antiarrhythmic drug.

AREAS COVERED:

Authors collected data on adverse effects reported in 49 randomized placebo-controlled trials with amiodarone. Adverse effects were classified according to the organ/system involved. Pooled estimates of the number needed to treat (NNT) and to harm (NNH) versus placebo were calculated.

EXPERT OPINION:

Amiodarone is effective for both the acute conversion of atrial fibrillation (AF) (11 trials, NNT = 4 at 24 h; p = 0.003) and the prevention of postoperative AF (18 trials, NNT = 8; p < 0.001), although with an increased risk of bradycardia, hypotension, nausea or phlebitis (pooled NNH = 4; p < 0.001). Amiodarone administration for the maintenance of sinus rhythm has a favorable net clinical benefit (pooled NNT = 3; p < 0.001 versus pooled NNH for either thyroid toxicity, gastrointestinal discomfort, skin toxicity or eye toxicity = 11; p < 0.001). Treatment with amiodarone for the prophylaxis of sudden cardiac death has less favorable net clinical benefit (15 trials, NNT = 38; p < 0.001 versus NNH for either thyroid toxicity, hepatic toxicity, pulmonary toxicity or bradycardia = 14; p < 0.001). Amiodarone treatment in this setting should be used in only selected cases.

PMID:
22324910
DOI:
10.1517/14740338.2012.660915
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Taylor & Francis
    Loading ...
    Support Center