Amiodarone versus other pharmacological interventions for prevention of sudden cardiac death

Juan Carlos Claro; Roberto Candia; Gabriel Rada; Fernando Baraona; Francisco Larrondo; Luz M Letelier

doi:10.1002/14651858.CD008093.pub2

Cochrane Database of Systematic Reviews

Amiodarona versus otras intervenciones farmacológicas para la prevención de la muerte súbita cardíaca

Información

DOI:

https://doi.org/10.1002/14651858.CD008093.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

08 diciembre 2015see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Corazón

Copyright:

Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Juan Carlos Claro

Correspondencia a: Departamento de Medicina Interna, Programa de Salud Basada en Evidencia, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile

[email protected]
Roberto Candia

Departamento de Gastroenterologia, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
Gabriel Rada

Department of Internal Medicine and Evidence-Based Healthcare Program, Faculty of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile
Fernando Baraona

Department of Cardiovascular Diseases, Faculty of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile
Francisco Larrondo

Department of Intensive Care, Edificio Clinico, 5th floor, Clinica Alemana, Santiago, Chile
Luz M Letelier

Departamento de Medicina Interna, Programa de Salud Basada en Evidencia, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile

Contributions of authors

Searching for trials: JCC/FL/GR
Handsearching: JCC/FB
Obtaining copies of trials: JCC
Selecting which trials to include (2 + 1 arbiter): JCC/RC + LML
Extracting data from trials (2 people): JCC/RC
Entering data into RevMan: RC/GR
Carrying out the analysis: RC/JCC/GR
Interpreting the analysis: JCC/RC/GR/LML
Drafting the final review: JCC/RC/FB/FL/GR/LML
Updating the review: JCC/RC

Sources of support

Internal sources

No sources of support provided

External sources

Proyecto FONIS SA11I2195 2011, Chile

The main authors won a grant from the National Comission for Scientific and Technological Investigation (CONICYT)

Declarations of interest

Juan Carlos Claro declares having received funding from a grant (FONIS (Fondo Nacional de Investigación y Desarrollo en Salud) project SA11l2195). This project was presented to CONICYT (Comisión Nacional de Investigación Científica y Tecnológica) in the year 2008 in order to receive some funding while carrying out the review, as the Government understood the research question addressed a pertinent issue for low‐ and middle‐income countries like Chile.
Luz M Letelier declares having received a clinical research grant from FONIS (Fondo Nacional de Investigación y Desarrollo en Salud).
Roberto Candia: none known.
Gabriel Rada: none known.
Fernando Baraona: none known.
Francisco Larrondo: none known.

Acknowledgements

The authors would like to acknowledge the invaluable help of the following collaborators who helped to translate articles from different languages: Kensuke Takaoka (Japanese), Marina Karanikolos (Russian), Taixiang Wu (Chinese), Nicole Martin (German) and Annie Tremp (French).

Version history

Published

Title

Stage

Authors

Version

2015 Dec 08

Amiodarone versus other pharmacological interventions for prevention of sudden cardiac death

Review

Juan Carlos Claro, Roberto Candia, Gabriel Rada, Fernando Baraona, Francisco Larrondo, Luz M Letelier

https://doi.org/10.1002/14651858.CD008093.pub2

2009 Oct 07

Amiodarone versus other pharmacological interventions for prevention of sudden cardiac death

Protocol

Juan Carlos Claro, Roberto Candia, Gabriel Rada, Francisco Larrondo, Fernando Baraona, Luz M Letelier

https://doi.org/10.1002/14651858.CD008093

Differences between protocol and review

We initially defined reduced LVEF as < 35%. However, we included studies with LVEF as low as 30%. A number of primary studies included participants with that LVEF, and we were not able to obtain individual patient data regarding solely those with LVEF < 35%.

We had initially stated that we would include participants with previous myocardial infarction (> 30 days prior to study). However, not a single study in the primary prevention setting included post‐MI participants of over 30 days. All of the studies included participants from 24 h post‐MI onwards. We thought that due to amiodarone pharmacodynamics, it would take more than three weeks to obtain plateau plasma levels, so the effect of amiodarone would not be apparent until the first month.

We did not plan to include Summary of Findings tables and GRADE assessment in the review at protocol stage but have done so in the review.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Funnel plot of comparison: 1 Amiodarone versus placebo or no treatment for primary prevention, outcome: 1.1 Sudden cardiac death.

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Figure 5

Funnel plot of comparison: 1 Amiodarone versus placebo or no treatment for primary prevention, outcome: 1.2 Cardiac mortality.

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Figure 6

Funnel plot of comparison: 1 Amiodarone versus placebo or no treatment for primary prevention, outcome: 1.3 All‐cause mortality.

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Analysis 1.1

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 1: Sudden cardiac death

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Analysis 1.2

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 2: Cardiac mortality

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Analysis 1.3

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 3: All‐cause mortality

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Analysis 1.4

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 4: Sudden cardiac death subgroup post‐ AMI patients

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Analysis 1.5

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 5: Sudden cardiac death subgroup heart failure

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Analysis 1.6

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 6: All‐cause mortality subgroup post‐AMI

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Analysis 1.7

Comparison 1: Amiodarone versus placebo or no treatment for primary prevention, Outcome 7: All‐cause mortality subgroup heart failure

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Analysis 2.1

Comparison 2: Amiodarone versus other antiarrhythmics for primary prevention, Outcome 1: Sudden cardiac death

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Analysis 2.2

Comparison 2: Amiodarone versus other antiarrhythmics for primary prevention, Outcome 2: Cardiac mortality

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Analysis 2.3

Comparison 2: Amiodarone versus other antiarrhythmics for primary prevention, Outcome 3: All‐cause mortality

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Analysis 3.1

Comparison 3: Amiodarone versus beta‐blockers for primary prevention, Outcome 1: Sudden cardiac death

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Analysis 3.2

Comparison 3: Amiodarone versus beta‐blockers for primary prevention, Outcome 2: Cardiac mortality

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Analysis 3.3

Comparison 3: Amiodarone versus beta‐blockers for primary prevention, Outcome 3: All‐cause mortality

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Analysis 4.1

Comparison 4: Amiodarone versus placebo or no treatment for secondary prevention, Outcome 1: Sudden cardiac death

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Analysis 4.2

Comparison 4: Amiodarone versus placebo or no treatment for secondary prevention, Outcome 2: All‐cause mortality

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Analysis 5.1

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 1: Sudden cardiac death

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Analysis 5.2

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 2: Cardiac mortality

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Analysis 5.3

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 3: All‐cause mortality

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Analysis 5.4

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 4: Sudden cardiac death subgroup with ICD

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Analysis 5.5

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 5: Sudden cardiac death subgroup without ICD

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Analysis 5.6

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 6: All‐cause mortality subgroup with ICD

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Analysis 5.7

Comparison 5: Amiodarone versus other antiarrhythmics for secondary prevention, Outcome 7: All‐cause mortality subgroup without ICD

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Analysis 6.1

Comparison 6: Amiodarone versus beta‐blockers for secondary prevention, Outcome 1: Sudden cardiac death

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Analysis 6.2

Comparison 6: Amiodarone versus beta‐blockers for secondary prevention, Outcome 2: All‐cause mortality

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Analysis 7.1

Comparison 7: Amiodarone versus sotalol for secondary prevention, Outcome 1: Sudden cardiac death

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Analysis 7.2

Comparison 7: Amiodarone versus sotalol for secondary prevention, Outcome 2: Cardiac mortality

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Analysis 7.3

Comparison 7: Amiodarone versus sotalol for secondary prevention, Outcome 3: All‐cause mortality

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Analysis 8.1

Comparison 8: Amiodarone and quality of life, Outcome 1: Quality of life (DASI at 30 months)

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Analysis 8.2

Comparison 8: Amiodarone and quality of life, Outcome 2: Quality of life (MHI‐5 at 30 months)

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Analysis 9.1

Comparison 9: Amiodarone versus placebo (adverse effects), Outcome 1: Hyperthyroidism

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Analysis 9.2

Comparison 9: Amiodarone versus placebo (adverse effects), Outcome 2: Hypothyroidism

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Analysis 9.3

Comparison 9: Amiodarone versus placebo (adverse effects), Outcome 3: Pulmonary

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Analysis 9.4

Comparison 9: Amiodarone versus placebo (adverse effects), Outcome 4: Discontinuation

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Analysis 10.1

Comparison 10: Amiodarone versus other antiarrhythmics (adverse effects), Outcome 1: Hyperthyroidism

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Analysis 10.2

Comparison 10: Amiodarone versus other antiarrhythmics (adverse effects), Outcome 2: Hypothyroidism

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Analysis 10.3

Comparison 10: Amiodarone versus other antiarrhythmics (adverse effects), Outcome 3: Pulmonary

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Analysis 10.4

Comparison 10: Amiodarone versus other antiarrhythmics (adverse effects), Outcome 4: Discontinuation

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Analysis 11.1

Comparison 11: Amiodarone versus no treatment (adverse effects), Outcome 1: Hyperthyroidism

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Analysis 11.2

Comparison 11: Amiodarone versus no treatment (adverse effects), Outcome 2: Hypothyroidism

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Analysis 11.3

Comparison 11: Amiodarone versus no treatment (adverse effects), Outcome 3: Pulmonary

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Summary of findings 1. Amiodarone compared to placebo or no treatment for high risk of Sudden Cardiac Death (primary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
Amiodarone versus placebo or no treatment for primary prevention
Patient or population: participants with high risk of sudden cardiac death (primary prevention) Settings: any setting Intervention: amiodarone Comparison: placebo or no treatment
	Assumed risk	Corresponding risk
	Placebo or no treatment	Amiodarone
Sudden cardiac death	Study population		RR 0.76 (0.66 to 0.88)	8383 (17 studies)	⊕⊕⊝⊝ low^a,b
	91 per 1000	70 per 1000 (61 to 81)
	Moderate
	114 per 1000	87 per 1000 (76 to 101)
All‐cause mortality	Study population		RR 0.88 (0.78 to 1.00)	8383 (17 studies)	⊕⊕⊝⊝ low^a,b
	203 per 1000	178 per 1000 (158 to 203)
	Moderate
	190 per 1000	167 per 1000 (148 to 190)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aRandomisation and allocation concealment methods not clear or not adequate in 10/16 studies, including studies with more weight. ^bFunnel plot compatible with publication bias. Given the nature of the intervention and the absence of other explanatory factors, publication bias is the most likely explanation.

Summary of findings 1. Amiodarone compared to placebo or no treatment for high risk of Sudden Cardiac Death (primary prevention)

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Summary of findings 2. Amiodarone compared to beta blockers for high risk of sudden cardiac death (primary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
Amiodarone versus beta blockers
Patient or population: beta blockers Settings: any setting Intervention: amiodarone
	Assumed risk	Corresponding risk
	Control	Amiodarone
Sudden cardiac death	Study population		RR 0.37 (0.11 to 1.22)	342 (2 studies)	⊕⊕⊝⊝ low^a,b
	56 per 1000	21 per 1000 (6 to 68)
	Moderate
	45 per 1000	17 per 1000 (5 to 55)
All‐cause mortality	Study population		RR 0.27 (0.1 to 0.75)	342 (2 studies)	⊕⊕⊝⊝ low^a,b
	101 per 1000	27 per 1000 (10 to 75)
	Moderate
	76 per 1000	21 per 1000 (8 to 57)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aBoth studies had serious limitations, including lack of blinding for participants and unclear generation of random sequence and allocation concealment. ^bWide confidence interval that does not exclude risk. However, point estimate shows a high magnitude effect.

Summary of findings 2. Amiodarone compared to beta blockers for high risk of sudden cardiac death (primary prevention)

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Summary of findings 3. Amiodarone compared to other antiarrhythmics for high risk of sudden cardiac death (primary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
Amiodarone versus other antiarrhythmics for high risk of sudden cardiac death (primary prevention)
Patient or population: participants with high risk of sudden cardiac death (primary prevention) Settings: any setting Intervention: amiodarone Comparison: other antiarrhythmics
	Assumed risk	Corresponding risk
	Other antiarrhythmics	Amiodarone
Sudden cardiac death	Study population		RR 0.44 (0.19 to 1)	540 (3 studies)	⊕⊕⊕⊝ moderate^a,b
Sudden cardiac death	65 per 1000	28 per 1000 (12 to 65)	RR 0.44 (0.19 to 1)	540 (3 studies)	⊕⊕⊕⊝ moderate^a,b
All‐cause mortality	Study population		RR 0.37 (0.18 to 0.76)	540 (3 studies)	⊕⊕⊕⊝ moderate^a
All‐cause mortality	100 per 1000	37 per 1000 (18 to 76)	RR 0.37 (0.18 to 0.76)	540 (3 studies)	⊕⊕⊕⊝ moderate^a
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aAll studies had serious limitations, including lack of blinding for participants and unclear allocation concealment. ^bEven though the CI crosses the line of null effect, we did not decrease the quality of the evidence since the point estimate clearly shows benefit and is consistent with the direction of the other outcomes.

Summary of findings 3. Amiodarone compared to other antiarrhythmics for high risk of sudden cardiac death (primary prevention)

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Summary of findings 4. Amiodarone compared to placebo or no treatment for high risk of sudden cardiac death (secondary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
Amiodarone compared to placebo or no treatment for high risk of sudden cardiac death (secondary prevention)
Patient or population: participants with high risk of sudden cardiac death (secondary prevention) Settings: any setting Intervention: amiodarone Comparison: placebo or no treatment
	Assumed risk	Corresponding risk
	Placebo or no treatment	Amiodarone
Sudden cardiac death	Study population		RR 4.32 (0.87 to 21.49)	440 (2 studies)	⊕⊝⊝⊝ very low^a,b
Sudden cardiac death	8 per 1000	35 per 1000 (7 to 174)	RR 4.32 (0.87 to 21.49)	440 (2 studies)	⊕⊝⊝⊝ very low^a,b
All‐cause mortality	Study population		RR 3.05 (1.33 to 7.01)	440 (2 studies)	⊕⊝⊝⊝ very low^a,b
	32 per 1000	99 per 1000 (43 to 227)
	Moderate
	35 per 1000	107 per 1000 (47 to 245)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aVery serious imprecision: quality of the evidence was downgraded two levels because the CI was very wide and includes both important risks and benefits, and because there was a very low number of events. ^bPublication bias suspected, given likelihood of publication bias in the studies of primary prevention for the same comparison, and the results showing possible harm.

Summary of findings 4. Amiodarone compared to placebo or no treatment for high risk of sudden cardiac death (secondary prevention)

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Summary of findings 5. Amiodarone compared to other antiarrhythmics for high risk of sudden cardiac death (secondary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
Amiodarone versus other antiarrhythmics for high risk of sudden cardiac death (secondary prevention)
Patient or population: participants with high risk of sudden cardiac death (secondary prevention) Settings: any setting Intervention: amiodarone Comparison: other antiarrhythmics
	Assumed risk	Corresponding risk
	Other antiarrhythmics	Amiodarone
Sudden cardiac death	Study population		RR 1.40 (0.56 to 3.52)	839 (4 studies)	⊕⊝⊝⊝ very low^a,b,c
Sudden cardiac death	99 per 1000	138 per 1000 (55 to 347)	RR 1.40 (0.56 to 3.52)	839 (4 studies)	⊕⊝⊝⊝ very low^a,b,c
All‐cause mortality	Study population		RR 1.03 (0.75 to 1.42)	898 (5 studies)	⊕⊕⊝⊝ low^a,b
All‐cause mortality	193 per 1000	198 per 1000 (144 to 273)	RR 1.03 (0.75 to 1.42)	898 (5 studies)	⊕⊕⊝⊝ low^a,b
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aAll studies had serious limitations, including 4/5 not blinded for participants. ^bWide confidence interval that does not rule out important benefit or risk. ^cDowngraded due to inconsistency (I² = 72%).

Summary of findings 5. Amiodarone compared to other antiarrhythmics for high risk of sudden cardiac death (secondary prevention)

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Summary of findings 6. Amiodarone compared to beta blockers for high risk of sudden cardiac death (secondary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
Amiodarone compared to beta blockers for high risk of sudden cardiac death (secondary prevention)
Patient or population: participants with high risk of sudden cardiac death (secondary prevention) Settings: any setting Intervention: amiodarone Comparison: beta blockers
	Assumed risk	Corresponding risk
	Beta blockers	Amiodarone
Sudden cardiac death	Study population		RR 0.84 (0.55 to 1.27)	189 (1 study)	⊕⊝⊝⊝ very low^a,b
Sudden cardiac death	351 per 1000	294 per 1000 (193 to 445)	RR 0.84 (0.55 to 1.27)	189 (1 study)	⊕⊝⊝⊝ very low^a,b
All‐cause mortality	Study population		RR 0.96 (0.7 to 1.32)	189 (1 study)	⊕⊝⊝⊝ very low^a,b
All‐cause mortality	454 per 1000	435 per 1000 (318 to 599)	RR 0.96 (0.7 to 1.32)	189 (1 study)	⊕⊝⊝⊝ very low^a,b
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aThe only study has serious limitations, including lack of blinding for participants. ^bOnly one study; quality of the evidence was downgraded two levels because confidence interval includes both important benefit and risk.

Summary of findings 6. Amiodarone compared to beta blockers for high risk of sudden cardiac death (secondary prevention)

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Summary of findings 7. Amiodarone compared to sotalol for high risk of sudden cardiac death (secondary prevention)

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
Amiodarone versus sotalol for high risk of sudden cardiac death (secondary prevention)
Patient or population: participants with high risk of sudden cardiac death (secondary prevention) Settings: any setting Intervention: amiodarone Comparison: sotalol
	Assumed risk	Corresponding risk
	Sotalol	Amiodarone
Sudden cardiac death	Study population		RR 2.87 (0.32 to 25.55)	45 (1 study)	⊕⊝⊝⊝ very low^a,b
Sudden cardiac death	45 per 1000	130 per 1000 (15 to 1000)	RR 2.87 (0.32 to 25.55)	45 (1 study)	⊕⊝⊝⊝ very low^a,b
All‐cause mortality	Study population		RR 1.08 (0.41 to 2.83)	104 (2 studies)	⊕⊝⊝⊝ very low^a,b
	137 per 1000	148 per 1000 (56 to 388)
	Moderate
	132 per 1000	143 per 1000 (54 to 374)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aThe only study has serious limitations, including lack of blinding for participants. ^bOnly one study; quality of the evidence was downgraded two levels because confidence interval includes both important benefit and risk.

Summary of findings 7. Amiodarone compared to sotalol for high risk of sudden cardiac death (secondary prevention)

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Comparison 1. Amiodarone versus placebo or no treatment for primary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Sudden cardiac death Show forest plot	17	8383	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.66, 0.88]

1.2 Cardiac mortality Show forest plot	17	8383	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.77, 0.96]

1.3 All‐cause mortality Show forest plot	17	8383	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.78, 1.00]

1.4 Sudden cardiac death subgroup post‐ AMI patients Show forest plot	6	3377	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.46, 0.91]

1.5 Sudden cardiac death subgroup heart failure Show forest plot	11	5006	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.67, 0.93]

1.6 All‐cause mortality subgroup post‐AMI Show forest plot	6	3377	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.61, 1.16]

1.7 All‐cause mortality subgroup heart failure Show forest plot	11	5006	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.80, 1.01]

Comparison 1. Amiodarone versus placebo or no treatment for primary prevention

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Comparison 2. Amiodarone versus other antiarrhythmics for primary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Sudden cardiac death Show forest plot	3	540	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.19, 1.00]

2.2 Cardiac mortality Show forest plot	3	540	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.20, 0.86]

2.3 All‐cause mortality Show forest plot	3	540	Risk Ratio (M‐H, Random, 95% CI)	0.37 [0.18, 0.76]

Comparison 2. Amiodarone versus other antiarrhythmics for primary prevention

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Comparison 3. Amiodarone versus beta‐blockers for primary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Sudden cardiac death Show forest plot	2	342	Risk Ratio (M‐H, Random, 95% CI)	0.37 [0.11, 1.22]

3.2 Cardiac mortality Show forest plot	2	342	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.11, 0.84]

3.3 All‐cause mortality Show forest plot	2	342	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.10, 0.75]

Comparison 3. Amiodarone versus beta‐blockers for primary prevention

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Comparison 4. Amiodarone versus placebo or no treatment for secondary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Sudden cardiac death Show forest plot	2	440	Risk Ratio (M‐H, Random, 95% CI)	4.32 [0.87, 21.49]

4.2 All‐cause mortality Show forest plot	2	440	Risk Ratio (M‐H, Random, 95% CI)	3.05 [1.33, 7.01]

Comparison 4. Amiodarone versus placebo or no treatment for secondary prevention

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Comparison 5. Amiodarone versus other antiarrhythmics for secondary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Sudden cardiac death Show forest plot	4	839	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.56, 3.52]

5.2 Cardiac mortality Show forest plot	2	273	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.49, 1.21]

5.3 All‐cause mortality Show forest plot	5	898	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.75, 1.42]

5.4 Sudden cardiac death subgroup with ICD Show forest plot	1	377	Risk Ratio (M‐H, Random, 95% CI)	24.45 [2.79, 214.59]

5.5 Sudden cardiac death subgroup without ICD Show forest plot	2	234	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.45, 2.05]

5.6 All‐cause mortality subgroup with ICD Show forest plot	1	377	Risk Ratio (M‐H, Random, 95% CI)	1.96 [0.98, 3.93]

5.7 All‐cause mortality subgroup without ICD Show forest plot	3	293	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.72, 1.31]

Comparison 5. Amiodarone versus other antiarrhythmics for secondary prevention

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Comparison 6. Amiodarone versus beta‐blockers for secondary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Sudden cardiac death Show forest plot	1	189	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.55, 1.27]

6.2 All‐cause mortality Show forest plot	1	189	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.70, 1.32]

Comparison 6. Amiodarone versus beta‐blockers for secondary prevention

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Comparison 7. Amiodarone versus sotalol for secondary prevention

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Sudden cardiac death Show forest plot	1	45	Risk Ratio (M‐H, Random, 95% CI)	2.87 [0.32, 25.55]

7.2 Cardiac mortality Show forest plot	1	45	Risk Ratio (M‐H, Random, 95% CI)	1.43 [0.26, 7.78]

7.3 All‐cause mortality Show forest plot	2	104	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.41, 2.83]

Comparison 7. Amiodarone versus sotalol for secondary prevention

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Comparison 8. Amiodarone and quality of life

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
8.1 Quality of life (DASI at 30 months) Show forest plot	1	1160	Mean Difference (IV, Random, 95% CI)	1.20 [‐0.56, 2.96]

8.2 Quality of life (MHI‐5 at 30 months) Show forest plot	1	1124	Mean Difference (IV, Random, 95% CI)	2.20 [‐0.26, 4.66]

Comparison 8. Amiodarone and quality of life

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Comparison 9. Amiodarone versus placebo (adverse effects)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
9.1 Hyperthyroidism Show forest plot	8	5972	Risk Ratio (M‐H, Random, 95% CI)	4.14 [1.54, 11.17]

9.2 Hypothyroidism Show forest plot	8	4008	Risk Ratio (M‐H, Random, 95% CI)	6.13 [2.46, 15.28]

9.3 Pulmonary Show forest plot	12	5924	Risk Ratio (M‐H, Random, 95% CI)	1.66 [1.15, 2.40]

9.4 Discontinuation Show forest plot	13	7616	Risk Ratio (M‐H, Random, 95% CI)	1.45 [1.26, 1.67]

Comparison 9. Amiodarone versus placebo (adverse effects)

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Comparison 10. Amiodarone versus other antiarrhythmics (adverse effects)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
10.1 Hyperthyroidism Show forest plot	3	514	Risk Ratio (M‐H, Random, 95% CI)	7.43 [1.33, 41.57]

10.2 Hypothyroidism Show forest plot	4	886	Risk Ratio (M‐H, Random, 95% CI)	7.77 [1.85, 32.68]

10.3 Pulmonary Show forest plot	6	1296	Risk Ratio (M‐H, Random, 95% CI)	2.30 [0.36, 14.67]

10.4 Discontinuation Show forest plot	8	1438	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.84, 1.33]

Comparison 10. Amiodarone versus other antiarrhythmics (adverse effects)

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Comparison 11. Amiodarone versus no treatment (adverse effects)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
11.1 Hyperthyroidism Show forest plot	3	414	Risk Ratio (M‐H, Random, 95% CI)	4.97 [0.60, 41.16]

11.2 Hypothyroidism Show forest plot	3	414	Risk Ratio (M‐H, Random, 95% CI)	12.82 [0.73, 225.33]

11.3 Pulmonary Show forest plot	2	405	Risk Ratio (M‐H, Random, 95% CI)	14.79 [0.85, 256.43]

Comparison 11. Amiodarone versus no treatment (adverse effects)

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Amiodarona versus otras intervenciones farmacológicas para la prevención de la muerte súbita cardíaca

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