Amiodarone use after acute myocardial infarction complicated by heart failure and/or left ventricular dysfunction may be associated with excess mortality.
BACKGROUND
We sought to assess the association of amiodarone use with mortality during consecutive periods in patients with post-acute myocardial infarction with left ventricular systolic dysfunction and/or HF treated with a contemporary medical regimen.


METHODS
This study used data from VALIANT, a randomized comparison of valsartan, captopril, or both in patients with acute myocardial infarction with HF and/or left ventricular systolic dysfunction. We compared baseline characteristics of 825 patients treated with amiodarone at randomization with 13,875 patients not treated with amiodarone. Using Cox models, we examined the association of amiodarone use with subsequent mortality during consecutive periods after randomization (days 1-16, 17-45, 46-198, and 199-1096).


RESULTS
Patients treated with amiodarone were older, had higher Killip class, and were more likely to have a history of diabetes mellitus and hypertension. Adjusting for baseline predictors of mortality, we found that amiodarone use was associated with a significant increase in mortality during 3 of the 4 periods: hazard ratio 1.5, 95% CI (1.1-2.0), P = .02, for days 1 to 16; 2.1 (1.5-2.9), P < .001, for days 17 to 45; 1.1 (0.83-1.46), P = .51, for days 46 to 198; and 1.4 (1.2-1.6), P < .001, for days 199 to 1096.


CONCLUSIONS
In this study, amiodarone use was associated with excess early and late all-cause and cardiovascular mortality. These observational findings are in contrast to earlier randomized trials of amiodarone and need to be validated prospectively.
Thomas
Kevin L
KL
Duke Clinical Research Institute, Duke University Medical Center, Durham NC 27710, USA. kevin.thomas@duke.edu
Al-Khatib
Sana M
SM
Lokhnygina
Yuliya
Y
Solomon
Scott D
SD
Kober
Lars
L
McMurray
John J V
JJ
Califf
Robert M
RM
Velazquez
Eric J
EJ
D000368:Aged; D000638:Amiodarone / Q000008:administration & dosage / Q000009:adverse effects*; D002216:Captopril / Q000008:administration & dosage; D002423:Cause of Death; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D011336:Probability; D016016:Proportional Hazards Models; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016019:Survival Analysis; D013777:Tetrazoles / Q000008:administration & dosage; D016896:Treatment Outcome; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000068756:Valsartan; D018754:Ventricular Dysfunction / Q000188:drug therapy / Q000209:etiology / Q000401:mortality
D013777:Tetrazoles; D000068756:Valsartan; D002216:Captopril; D014633:Valine; D000638:Amiodarone