Amiodarone berbanding intervensi farmakologi lain untuk pencengahan kematian jantung mengejut.
Abstract
Background
Sudden cardiac death (SCD) is one of the main causes of cardiac death. There are two main strategies to prevent it: managing cardiovascular risk factors and reducing the risk of ventricular arrhythmias. Implantable cardiac defibrillators (ICDs) constitute the standard therapy for both primary and secondary prevention; however, they are not widely available in settings with limited resources. The antiarrhythmic amiodarone has been proposed as an alternative to ICD.
Objectives
To evaluate the effectiveness of amiodarone for primary or secondary prevention in SCD compared with placebo or no intervention or any other antiarrhythmic drugs in participants at high risk (primary prevention) or who have recovered from a cardiac arrest or a syncope due to Ventricular Tachycardia/Ventricular Fibrillation, or VT/VF (secondary prevention).
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), EMBASE (OVID), CINAHL (EBSCO) and LILACS on 26 March 2015. We reviewed reference lists of included studies and selected reviews on the topic, contacted authors of included studies, screened relevant meetings and searched in registers for ongoing trials. We applied no language restrictions.
Selection criteria
Randomised and quasi‐randomised trials assessing the efficacy of amiodarone versus placebo, no intervention, or other antiarrhythmics in adults. For primary prevention we considered participants at high risk for SCD. For secondary prevention we considered participants recovered from cardiac arrest or syncope due to ventricular arrhythmias.
Data collection and analysis
Two authors independently assessed the trials for inclusion and extracted relevant data. We contacted trial authors for missing data. We performed meta‐analyses using a random‐effects model. We calculated risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CIs). Three studies included more than one comparison.
Main results
We included 24 studies (9,997 participants). Eighteen studies evaluated amiodarone for primary prevention and six for secondary prevention. Only three studies used an ICD concomitantly with amiodarone for the comparison (all of them for secondary prevention).
For primary prevention, amiodarone compared to placebo or no intervention (17 studies, 8383 participants) reduced SCD (RR 0.76; 95% CI 0.66 to 0.88), cardiac mortality (RR 0.86; 95% CI 0.77 to 0.96) and all‐cause mortality (RR 0.88; 95% CI 0.78 to 1.00). The quality of the evidence was low.
Compared to other antiarrhythmics (three studies, 540 participants), amiodarone reduced SCD (RR 0.44; 95% CI 0.19 to 1.00), cardiac mortality (RR 0.41; 95% CI 0.20 to 0.86) and all‐cause mortality (RR 0.37; 95% CI 0.18 to 0.76). The quality of the evidence was moderate.
For secondary prevention, amiodarone compared to placebo or no intervention (two studies, 440 participants) appeared to increase the risk of SCD (RR 4.32; 95% CI 0.87 to 21.49) and all‐cause mortality (RR 3.05; 1.33 to 7.01). However, the quality of the evidence was very low. Compared to other antiarrhythmics (four studies, 839 participants) amiodarone appeared to increase the risk of SCD (RR 1.40; 95% CI 0.56 to 3.52; very low quality of evidence), but there was no effect in all‐cause mortality (RR 1.03; 95% CI 0.75 to 1.42; low quality evidence).
Amiodarone was associated with an increase in pulmonary and thyroid adverse events.
Authors' conclusions
There is low to moderate quality evidence that amiodarone reduces SCD, cardiac and all‐cause mortality when compared to placebo or no intervention for primary prevention, and its effects are superior to other antiarrhythmics.
It is uncertain if amiodarone reduces or increases SCD and mortality for secondary prevention because the quality of the evidence was very low.
PICO
Plain language summary
Amiodarone untuk mencegah kematian jantung mengejut
Latar belakang
Kematian jantung mengejut (SCD) adalah punca utama kematian pada masa kini. Orang yang berisiko tinggi (terutamanya mana‐mana jenis penyakit jantung) mati secara tidak disangka, terutamanya daripada aritmia (degupan jantung yang tak teratur). Rawatan pilihan adalah peranti yang dipanggil implan defibrilator jantung (ICD), namun ia tidak didapati secara meluas di negara‐negara berpendapatan rendah atau sederhana. Amiodarone, sejenis ubat antiaritmia, mungkin boleh mengurangkan kejadian peristiwa‐peristiwa ini dan boleh menjadi pilihan apabila ICD tidak boleh didapati.
Ciri‐ciri kajian
Kami mencari pangkalan data saintifik untuk kajian klinikal yang membandingkan kesan amiodarone dengan ubat antiaritmia lain atau plasebo pada SCD, kematian dan kesan‐kesan sampingan. Kami memasukan peserta dewasa berisiko tinggi atau yang sebelum ini telah mendapat serangan jantung, satu kepincangan tugas jantung yang serius dan boleh menyebabkan aritmia. Bukti adalah terkini sehingga Mac 2015.
Keputusan utama
Kami mendapati 24 kajian yang terdiri daripada 9,997 peserta. Dalam kalangan peserta yang berisiko tinggi, bukti menunjukkan bahawa amiodarone boleh mencegah SCD atau kematian berbanding dengan plasebo, dan ia mungkin lebih baik daripada ubat antiaritmia yang lain.
Sebaliknya, dalam kalangan peserta yang telah mengalami serangan jantung sebelum ini, adalah tidak pasti sama ada amiodarone dapat meningkatkan atau mengurangkan risiko episod serangan jantung yang baru atau kematian.
Tambahan pula, amiodarone boleh menyebabkan atau menerukkan lagi kesan buruk pada tiroid atau paru‐paru, berbanding dengan plasebo atau ubat antiaritmia yang lain.
Kualiti bukti
Kualiti bukti keseluruhan kajian‐kajian ini adalah rendah.
