Furthermore, AF may represent an independent risk factor for death. Clinicians may restore and maintain sinus rhythm or may choose to control ventricular rate without attempting to terminate AF. The Pharmacological Intervention in Atrial Fibrillation PIAF trial showed no difference between these 2 strategies in improvement of symptoms and quality of life.
Nevertheless, selected patients and those younger than 65 years may benefit from conversion to sinus rhythm. In considering amiodarone for converting AF to sinus rhythm, clinicians should be aware of the magnitude of its effectiveness, ideally summarized in a systematic review of randomized trials. We found one such review that addressed the efficacy and safety of different antiarrhythmic drugs compared with placebo, digoxin, or calcium channel blockers CCBs in conversion of nonpostoperative AF to sinus rhythm.
We therefore conducted a systematic review and meta-analysis of randomized clinical trials on the effectiveness and safety of amiodarone in achieving sinus rhythm in patients with AF of any etiology. Methods Eligibility criteria We included studies that met the following criteria: We included published and unpublished studies without language restriction. Studies that presented insufficient data regarding our primary outcome, conversion to sinus rhythm, for which we could not get additional information from the authors, were also excluded.
Our secondary outcomes were mortality and adverse events AEs , but we did not exclude from the primary analysis studies that failed to report these outcomes. We restricted the search to articles indexed as randomized controlled trials publication type or drug therapy subject heading or those that included the words random, placebo, or trial in their titles or abstracts.
We reviewed the reference lists from major cardiology and internal medicine textbooks, UpToDate version volume 8, No.
Other attempts to identify unpublished studies included contact with experts in the field, authors of included articles, and 1 drug company. Selection Two of 3 authors L. Citations that 1 reviewer considered relevant were further assessed independently by 2 of us L. We contacted 18 authors of articles with ambiguity of their study design and asked them to clarify issues to decide their inclusion. Of these, 7 replied. For the other 11 studies, we based our decision on available information.
We measured agreement and resolved disagreement by consensus. The reviewers also identified duplicate or updated publications and contacted the authors to clarify uncertainty about originality of data. We included only the most complete data set in our review.
Quality assessment Two authors L. Reviewers classified concealment of treatment allocation as adequate if those enrolling patients called a central randomization facility or opened sealed opaque envelopes or if the central pharmacy prepared and distributed numbered drug kits. Reviewers classified any other methods, such as nonsealed envelopes or medical chart numbers quasi-randomization as inadequate. When the article failed to make concealment methods explicit and the author failed to provide adequate clarification, we assumed concealment was inadequate.
We measured agreement and resolved disagreement by consensus when no more information could be obtained from authors.
Data extraction Two of 3 authors L. For articles reporting outcomes at more than 1 time point, the primary analysis focused on the measurement closest to but no later than 4 weeks from randomization. For a study that compared amiodarone with digoxin or diltiazem hydrochloride, 11 our analysis pooled data from the 2 control arms; for a study that compared placebo with 2 different doses of amiodarone, 12 we pooled data from the amiodarone arms.
We considered AEs described in the studies irrespective of their putative relation to the drugs and extracted the number of events rather than the number of patients. We included AEs that we considered to be serious, defined as follows: We contacted the authors of all included studies for additional essential information missing from the report or to clarify inconsistent or ambiguous data relevant to our analysis. We combined the RR from each study by means of a meta-analytic technique using a random-effects model as described by DerSimonian and Laird.
We explored possible explanations for heterogeneity according to a priori hypotheses, which included differences in prognostic baseline patient characteristics, type of control treatment, time of outcome measurement, and methodological quality.
Specifically, we compared the results of studies grouped by the following factors: Recognizing that any cut point is to some extent arbitrary, we chose cut points before analyzing the data using 2 criteria. First, thresholds had to be biologically sensible; and second, they had to divide the trials into 2 subgroups with a more or less similar number of trials.
For methodological issues, we considered concealment of treatment allocation adequate vs inadequate and masking of caregivers and outcome assessors masked vs not masked. We considered caregivers and outcome assessors together because all included trials had the same masking status for these participants. Furthermore, we looked for difference in results between studies reported as abstracts in cardiology meetings and full reports published in medical journals.
The logarithm transformation of the RR and the z test provided the statistical approach for comparing the magnitude of treatment effect between the 2 groups. Any hypothesis for which the difference between subgroups reached a predefined P value of less than.
Funnel plot 15 review provided a strategy to assess publication bias. We also undertook a supplemental analysis using absolute risk difference RD as the measure of treatment effect. We pooled the RDs from each trial according to a random-effects meta-analytic model. We contacted the company but were unable to obtain the data at the time of this writing. Table 1 describes the characteristics of the 21 included studies. Seven studies 12 , 22 , 24 - 26 , 29 , 33 were reported as abstracts presented in cardiology meetings, of which two 24 , 29 have been published while we prepared this article.
We received a reply from 5 of these 7 authors. The other 14 studies were full articles published in medical journals. The control treatment consisted of placebo in 10 studies, no treatment in 1, digoxin in 5, CCB diltiazem or verapamil hydrochloride in 4, and digoxin and diltiazem in 1. Table 1 summarizes the quality of the studies. Patient characteristics Investigators randomized a total of patients. Although the frequency of such proarrhythmic events does not appear greater with amiodarone than with many other agents used in this population, the effects are prolonged when they occur.
Even in patients at high risk of arrhythmic death, in whom the toxicity of amiodarone is an acceptable risk, amiodarone poses major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first. The difficulty of using amiodarone effectively and safely itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose of amiodarone is given, and a response generally requires at least one week, usually two or more.
Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months.
The patient is obviously at great risk during this time and may need prolonged hospitalization. Finally, he landed in the emergency room and they treated him for pneumonia. It took almost 2 days for them to identify the cause After 62 days in ICU he passed I started a website and a Facebook group to help others navigate these waters. It's amazing to me how many people have experienced and are experiencing the same terrible outcome.
Avoid this drug unless you are taking it as a last resort! The drug worked well for getting the heart back into Sinus Rhythm, but it has come at a horrible price! I now have "pulmonary toxicity" due to this drug and am having recurring bouts of pneumonia.
If I had known then what I know now, I would have asked the doctor for something else. When you have toxicity, they can see "ground glass" in your lungs. The pain is horrible sometimes and I find myself not wanting to breathe deeply.
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