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Health Technology Assessment... Oct 2010This paper presents a summary of the evidence review group (ERG) report on the clinical effectiveness and cost-effectiveness of dronedarone for the treatment of atrial... (Review)
Review
This paper presents a summary of the evidence review group (ERG) report on the clinical effectiveness and cost-effectiveness of dronedarone for the treatment of atrial fibrillation (AF) or atrial flutter based upon a review of the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The population considered in the submission were adult clinically stable patients with a recent history of or current non-permanent AF. Comparators were the current available anti-arrhythmic drugs: class 1c agents (flecainide and propafenone), sotalol and amiodarone. Outcomes were AF recurrence, all-cause mortality, stroke, treatment discontinuations (due to any cause or due to adverse events) and serious adverse events. The main evidence came from four phase III randomised controlled trials, direct and indirect meta-analyses from a systematic review, and a synthesis of the direct and indirect evidence using a mixed-treatment comparison. Overall, the results from the different synthesis approaches showed that the odds of AF recurrence appeared statistically significantly lower with dronedarone and other anti-arrhythmic drugs than with non-active control, and that the odds of AF recurrence are statistically significantly higher for dronedarone than for amiodarone. However, the results for outcomes of all-cause mortality, stroke and treatment discontinuations and serious adverse events were all uncertain. A discrete event simulation model was used to evaluate dronedarone versus antiarrhythmic drugs and standard therapy alone. The incremental cost-effectiveness ratio of dronedarone was relatively robust and less than 20,000 pounds per quality-adjusted life-year. Exploratory work undertaken by the ERG identified that the main drivers of cost-effectiveness were the benefits assigned to dronedarone for all-cause mortality and stroke. Dronedarone is not cost-effective relative to its comparators when the only effect of treatment is a reduction in AF recurrences. In conclusion, uncertainties remain in the clinical effectiveness and cost-effectiveness of dronedarone. In particular, the clinical evidence for the major drivers of cost-effectiveness (all-cause mortality and stroke), and consequently the additional benefits attributed in the economic model to dronedarone compared to other anti-arrhythmic drugs are highly uncertain. The final guidance, issued by NICE on 25 August 2010, states that: Dronedarone is recommended as an option for the treatment of non-permanent atrial fibrillation only in people: whose atrial fibrillation is not controlled by first-line therapy (usually including beta-blockers), that is, as a second-line treatment option, and who have at least one of the following cardiovascular risk factors: - hypertension requiring drugs of at least two different classes, diabetes mellitus, previous transient ischaemic attack, stroke or systemic embolism, left atrial diameter of 50 mm or greater, left ventricular ejection fraction less than 40% (noting that the summary of product characteristics [SPC] does not recommend dronedarone for people with left ventricular ejection fraction less than 35% because of limited experience of using it in this group) or age 70 years or older, and who do not have unstable New York Heart Association (NYHA) class III or IV heart failure. Furthermore, 'People who do not meet the criteria above who are currently receiving dronedarone should have the option to continue treatment until they and their clinicians consider it appropriate to stop'.
Topics: Adult; Aged; Aged, 80 and over; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Atrial Flutter; Clinical Trials, Phase III as Topic; Cost-Benefit Analysis; Dronedarone; Humans; Middle Aged; Randomized Controlled Trials as Topic
PubMed: 21047492
DOI: 10.3310/hta14suppl2/08 -
Journal of Clinical Medicine Jul 2023Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery; it is associated with morbidity and mortality. We undertook this review... (Review)
Review
BACKGROUND
Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery; it is associated with morbidity and mortality. We undertook this review to compare the effects of rhythm vs. rate control in this population.
METHODS
We searched MEDLINE, Embase and CENTRAL to March 2023. We included randomized trials and observational studies comparing rhythm to rate control in cardiac surgery patients with POAF. We used a random-effects model to meta-analyze data and rated the quality of evidence using GRADE.
RESULTS
From 8,110 citations, we identified 8 randomized trials (990 patients). Drug regimens used for rhythm control included amiodarone in four trials, other class III anti-arrhythmics in one trial, class I anti-arrhythmics in four trials and either a class I or III anti-arrhythmic in one trial. Rhythm control compared to rate control did not result in a significant difference in length of stay (mean difference -0.8 days; 95% CI -3.0 to +1.4, I = 97%), AF recurrence within 1 week (130 events; risk ratio [RR] 1.1; 95%CI 0.6-1.9, I = 54%), AF recurrence up to 1 month (37 events; RR 0.9; 95%CI 0.5-1.8, I = 0%), AF recurrence up to 3 months (10 events; RR 1.0; 95%CI 0.3-3.4, I = 0%) or mortality (25 events; RR 1.6; 95%CI 0.7-3.5, I = 0%). Effect measures from seven observational studies (1428 patients) did not differ appreciably from those in randomized trials.
CONCLUSIONS
Although atrial fibrillation is common after cardiac surgery, limited low-quality data guide its management. Limited available evidence suggests no clear advantage to either rhythm or rate control. A large-scale randomized trial is needed to inform this important clinical question.
PubMed: 37445569
DOI: 10.3390/jcm12134534 -
The Cochrane Database of Systematic... Jan 2013Atrial fibrillation is a common post-operative complication of cardiac surgery and is associated with an increased risk of post-operative stroke, increased length of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Atrial fibrillation is a common post-operative complication of cardiac surgery and is associated with an increased risk of post-operative stroke, increased length of intensive care unit and hospital stays, healthcare costs and mortality. Numerous trials have evaluated various pharmacological and non-pharmacological prophylactic interventions for their efficacy in preventing post-operative atrial fibrillation. We conducted an update to a 2004 Cochrane systematic review and meta-analysis of the literature to gain a better understanding of the effectiveness of these interventions.
OBJECTIVES
The primary objective was to assess the effects of pharmacological and non-pharmacological interventions for preventing post-operative atrial fibrillation or supraventricular tachycardia after cardiac surgery. Secondary objectives were to determine the effects on post-operative stroke or cerebrovascular accident, mortality, cardiovascular mortality, length of hospital stay and cost of treatment during the hospital stay.
SEARCH METHODS
We searched the Cochrane Central Register of ControlLed Trials (CENTRAL) (Issue 8, 2011), MEDLINE (from 1946 to July 2011), EMBASE (from 1974 to July 2011) and CINAHL (from 1981 to July 2011).
SELECTION CRITERIA
We selected randomized controlled trials (RCTs) that included adult patients undergoing cardiac surgery who were allocated to pharmacological or non-pharmacological interventions for the prevention of post-operative atrial fibrillation or supraventricular tachycardia, except digoxin, potassium (K(+)), or steroids.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted study data and assessed trial quality.
MAIN RESULTS
One hundred and eighteen studies with 138 treatment groups and 17,364 participants were included in this review. Fifty-seven of these studies were included in the original version of this review while 61 were added, including 27 on interventions that were not considered in the original version. Interventions included amiodarone, beta-blockers, sotalol, magnesium, atrial pacing and posterior pericardiotomy. Each of the studied interventions significantly reduced the rate of post-operative atrial fibrillation after cardiac surgery compared with a control. Beta-blockers (odds ratio (OR) 0.33; 95% confidence interval) CI 0.26 to 0.43; I(2) = 55%) and sotalol (OR 0.34; 95% CI 0.26 to 0.43; I(2) = 3%) appear to have similar efficacy while magnesium's efficacy (OR 0.55; 95% CI 0.41 to 0.73; I(2) = 51%) may be slightly less. Amiodarone (OR 0.43; 95% CI 0.34 to 0.54; I(2) = 63%), atrial pacing (OR 0.47; 95% CI 0.36 to 0.61; I(2) = 50%) and posterior pericardiotomy (OR 0.35; 95% CI 0.18 to 0.67; I(2) = 66%) were all found to be effective. Prophylactic intervention decreased the hospital length of stay by approximately two-thirds of a day and decreased the cost of hospital treatment by roughly $1250 US. Intervention was also found to reduce the odds of post-operative stroke, though this reduction did not reach statistical significance (OR 0.69; 95% CI 0.47 to 1.01; I(2) = 0%). No significant effect on all-cause or cardiovascular mortality was demonstrated.
AUTHORS' CONCLUSIONS
Prophylaxis to prevent atrial fibrillation after cardiac surgery with any of the studied pharmacological or non-pharmacological interventions may be favored because of its reduction in the rate of atrial fibrillation, decrease in the length of stay and cost of hospital treatment and a possible decrease in the rate of stroke. However, this review is limited by the quality of the available data and heterogeneity between the included studies. Selection of appropriate interventions may depend on the individual patient situation and should take into consideration adverse effects and the cost associated with each approach.
Topics: Adrenergic beta-Antagonists; Adult; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Cardiac Pacing, Artificial; Cardiac Surgical Procedures; Humans; Magnesium Compounds; Pericardiectomy; Randomized Controlled Trials as Topic; Sotalol; Tachycardia, Supraventricular
PubMed: 23440790
DOI: 10.1002/14651858.CD003611.pub3 -
Frontiers in Cardiovascular Medicine 2022To evaluate the efficiency of amiodarone in preventing the occurrence of reperfusion ventricular fibrillation (RVF) after aortic cross-clamp (ACC) release in patients...
Effectiveness of Amiodarone in Preventing the Occurrence of Reperfusion Ventricular Fibrillation After the Release of Aortic Cross-Clamp in Open-Heart Surgery Patients: A Meta-Analysis.
OBJECTIVE
To evaluate the efficiency of amiodarone in preventing the occurrence of reperfusion ventricular fibrillation (RVF) after aortic cross-clamp (ACC) release in patients undergoing open-heart surgery.
METHODS
We searched the Web of Science, Cochrane Library, EMBASE, and PubMed databases through January 2021 for relevant studies addressing the efficacy of amiodarone in preventing RVF after ACC release in patients undergoing cardiac surgery. A complete statistical analysis was performed using RevMan 5.3. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to express the results of dichotomous outcomes using random or fixed-effect models. The chi-square test and test were used to calculate heterogeneity.
RESULTS
Seven studies (856 enrolled patients; 311 in the amiodarone group, 268 in the lidocaine group, and 277 in the placebo group) were selected for the meta-analysis. The incidence of RVF was significantly decreased in the amiodarone group compared to the placebo group (RR = 0.69, 95%CI: 0.50-0.94, = 0.02). However, amiodarone and lidocaine did not confer any significant difference (RR = 0.98, 95%CI: 0.61-1.59, = 0.94). The percentage of patients requiring electric defibrillation counter shocks (DCSs) did not confer any significant difference between patients administered amiodarone and lidocaine or placebo (RR = 1.58, 95%CI: 0.29-8.74, = 0.60; RR = 0.55, 95%CI: 0.27-1.10, = 0.09; respectively).
CONCLUSIONS
Amiodarone is more effective than a placebo in preventing RVF after ACC release in cardiac surgery. However, the amiodarone group required the same number of electrical DCSs to terminate RVF as the lidocaine or placebo groups.
PubMed: 35187132
DOI: 10.3389/fcvm.2022.821938 -
Current Cardiology Reviews 2022Junctional Ectopic Tachycardia (JET) is an arrhythmia originating from the AV junction, which may occur following congenital heart surgery, especially when the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Junctional Ectopic Tachycardia (JET) is an arrhythmia originating from the AV junction, which may occur following congenital heart surgery, especially when the intervention is near the atrioventricular junction.
OBJECTIVE
The aim of this systematic review and meta-analysis is to compare the effectiveness of amiodarone, dexmedetomidine, and magnesium in preventing JET following congenital heart surgery.
METHODS
This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement, where 11 electronic databases were searched from the date of inception to August 2020. The incidence of JET was calculated with the relative risk of 95% Confidence Interval (CI). Quality assessment of the included studies was assessed using the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.
RESULTS
Eleven studies met the predetermined inclusion criteria and were included in this meta-analysis. Amiodarone, dexmedetomidine, and magnesium significantly reduced the incidence of postoperative JET [Amiodarone: risk ratio 0.34; I2= 0%; Z=3.66 (P=0.0002); 95% CI 0.19-0.60. Dexmedetomidine: risk ratio 0.34; I2= 0%; Z=4.77 (P<0.00001); 95% CI 0.21-0.52. Magnesium: risk ratio 0.50; I2= 24%; Z=5.08 (P<0.00001); 95% CI 0.39-0.66].
CONCLUSION
All three drugs have shown promising results in reducing the incidence of JET. Our systematic review found that dexmedetomidine is better in reducing the length of ICU stays as well as mortality. In addition, dexmedetomidine also has the least pronounced side effects among the three. However, it should be noted that this conclusion was derived from studies with small sample sizes. Therefore, dexmedetomidine may be considered as the drug of choice for preventing JET.
Topics: Cardiac Surgical Procedures; Dexmedetomidine; Humans; Postoperative Complications; Tachycardia, Ectopic Junctional
PubMed: 34082685
DOI: 10.2174/1573403X17666210603113430 -
Circulation. Arrhythmia and... Dec 2021
Meta-Analysis
Topics: Administration, Oral; Amiodarone; Anti-Arrhythmia Agents; Heart Rate; Humans; Recovery of Function; Tachycardia, Supraventricular; Time Factors; Treatment Outcome
PubMed: 34802256
DOI: 10.1161/CIRCEP.121.010321 -
Frontiers in Cardiovascular Medicine 2022Double sequential external defibrillation (DSED) in cardiopulmonary resuscitation has shown different results in comparison with standard defibrillation in the treatment...
INTRODUCTION
Double sequential external defibrillation (DSED) in cardiopulmonary resuscitation has shown different results in comparison with standard defibrillation in the treatment of refractory ventricular fibrillation (RVF). This review aims to compare the advantages of DSED with standard defibrillation in the treatment of refractory ventricular fibrillation.
MATERIALS AND METHODS
PubMed, Embase, Web of Science, and Cochrane Library were searched from inception to May 1, 2022. Studies included adult patients who developed RVF. The study used random-effects and fixed-effects models for meta-analysis, which was reported by risk ratio (RR) with 95% confidence interval (CI), mean difference (MD), or standardized mean difference (SMD). The risk of bias in individual studies was assessed using the Robins-I tool for observational studies and the Cochrane Risk of Bias 2 (ROB-2) tool for clinical trials. Primary outcomes included the termination of RVF, prehospital return of spontaneous circulation (ROSC), survival to hospital admission, survival to hospital discharge, and good neurological recovery. Secondary outcomes included age, total defibrillation attempts, emergency medical system arrival time, and dose of epinephrine and amiodarone used.
RESULTS
In this systematic review and meta-analysis, 10 studies containing 1347 patients with available data on treatment outcomes were included. The pooled estimate was (RR 1.03, 95% CI, 0.89 to 1.19; = 0.42, = 0.678 > 0.05) for Termination of RVF, (RR 0.84, 95% CI, 0.63 to 1.11; = 1.23, = 0.219 > 0.05) for ROSC, (RR 0.86, 95% CI, 0.69 to 1.06; = 1.4, = 0.162 > 0.05) for survival to hospital admission, (RR 0.77, 95%CI, 0.52 to 1.15; = 1.26, = 0.206 > 0.05) for survival to hospital discharge, (RR 0.65, 95%CI, 0.35 to 1.22; = 1.33, = 0.184 > 0.05) for good neurologic recovery, (MD -1.01, 95%CI, -3.07 to 1.06; = 0.96, = 0.34 > 0.05) for age, (MD 2.27, 95%CI, 1.80 to 2.73; = 9.50, = 0.001 < 0.05) for total defibrillation attempts, (MD 1.10, 95%CI, -0.45 to 66; = 1.39, = 0.16 > 0.05) for emergency medical system arrival time, (SMD 0.34, 95%CI, 0.17 to 0.50; = 4.04, = 0.001 < 0.05) for epinephrine, and (SMD -0.30, 95%CI, -0.65 to -0.05; = 1.66, = 0.1 > 0.05) for amiodarone.
CONCLUSION
We discovered no differences between DSED and standard defibrillation in termination of RVF, prehospital return of spontaneous circulation, survival to hospital admission, survival to hospital discharge, good neurological outcome, emergency medical system arrival time, and amiodarone doses in patients with RVF. There were some differences in the number of defibrillations and epinephrine doses utilized during resuscitation.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=329354], identifier [CRD42022329354].
PubMed: 36505388
DOI: 10.3389/fcvm.2022.1017935 -
Journal of Cardiothoracic Surgery May 2024To evaluate the clinical efficacy and safety of intraoperative intravenous amiodarone for arrhythmia prevention in on-pump coronary artery bypass grafting (CABG)... (Meta-Analysis)
Meta-Analysis Review
The efficacy and safety of intraoperative intravenous amiodarone in patients undergoing on-pump coronary artery bypass grafting surgery: a systemic review and PRISMA-compliant meta-analysis.
BACKGROUND
To evaluate the clinical efficacy and safety of intraoperative intravenous amiodarone for arrhythmia prevention in on-pump coronary artery bypass grafting (CABG) patients.
METHODS
A meta-analysis of randomized controlled trials was conducted. Pubmed, Embase, Cochrane Library, Ovid, China National Knowledge Infrastructure, and the Wan Fang database until July 1th, 2023. The primary outcomes of interest included the incidences of intra- and post-operative atrial fibrillation (POAF), ventricular fibrillation, or any arrhythmia, including atrial fibrillation, ventricular fibrillation, ventricular tachycardia, premature ventricular contraction, and sinus bradycardia. For continuous and dichotomous variables, treatment effects were calculated as the weighted mean difference (WMD)/risk ratio (RR) and 95% confidence interval (CI).
RESULTS
A database search yielded 7 randomized controlled trials including 608 patients, where three studies, including three treatments (amiodarone, lidocaine, and saline), contributed to the clinical outcome of atrial fibrillation, ventricular fibrillation, or any arrhythmia. Meta-analysis demonstrated that amiodarone can significantly reduce the incidence of POAF (RR, 0.39; 95%CI: 0.20, 0.77; P = 0.007, I = 0%) in patients undergoing on-pump CABG; there was no statistically significant influence on intra-operative atrial fibrillation, intra- and post-operative ventricular fibrillation, or any arrhythmia.
CONCLUSIONS
The current study suggests that intraoperative administration of intravenous amiodarone may be safe and effective in preventing POAF in patients undergoing on-pump CABG. More well-designed clinical trials are needed to validate this result.
Topics: Humans; Amiodarone; Coronary Artery Bypass; Anti-Arrhythmia Agents; Arrhythmias, Cardiac; Intraoperative Care; Administration, Intravenous; Postoperative Complications; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38702789
DOI: 10.1186/s13019-024-02732-9 -
Drugs & Aging Feb 2023Drug-drug interactions (DDIs) can lead to medication-related harm, and the older population is at greatest risk. We conducted a systematic review and meta-analysis to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Drug-drug interactions (DDIs) can lead to medication-related harm, and the older population is at greatest risk. We conducted a systematic review and meta-analysis to estimate DDI prevalence and identify common DDIs in older community-dwelling adults.
METHODS
PubMed and EMBASE were searched for observational studies published between 01/01/2010 and 10/05/2021 reporting DDI prevalence in community-dwelling individuals aged ≥ 65 years. Nursing home and inpatient hospital studies were excluded. Study quality was assessed using the Joanna Briggs Institute critical appraisal tool. Meta-analysis was performed using a random-effects model with logit transformation. Heterogeneity was evaluated using Cochran's Q and I. DDI prevalence and 95% confidence intervals (CIs) are presented. All analyses were performed in R (version 4.1.2).
RESULTS
There were 5144 unique articles identified. Thirty-three studies involving 17,011,291 community-dwelling individuals aged ≥ 65 years met inclusion criteria. Thirty-one studies reported DDI prevalence at the study-participant level, estimates ranged from 0.8% to 90.6%. The pooled DDI prevalence was 28.8% (95% CI 19.3-40.7), with significant heterogeneity (p < 0.10; I = 100%; tau = 2.13) largely explained by the different DDI identification methods. Therefore, 26 studies were qualitatively synthesised and seven studies were eligible for separate meta-analyses. In a meta-analysis of three studies (N = 1122) using Micromedex, pooled DDI prevalence was 57.8% (95% CI 52.2-63.2; I = 69.6%, p < 0.01). In a meta-analysis of two studies (N = 809,113) using Lexi-Interact, pooled DDI prevalence was 30.3% (95% CI 30.2-30.4; I = 6.8%). In a meta-analysis of two studies (N = 947) using the 2015 American Geriatrics Society Beers criteria, pooled DDI prevalence was 16.6% (95% CI 5.6-40.2; I = 97.5%, p < 0.01). Common DDIs frequently involved cardiovascular drugs, including ACE inhibitor-potassium-sparing diuretic; amiodarone-digoxin; and amiodarone-warfarin.
CONCLUSIONS
DDIs are prevalent among older community-dwelling individuals; however, the methodology used to estimate these events varies considerably. A standardised methodology is needed to allow meaningful measurement and comparison of DDI prevalence.
Topics: Humans; Aged; Independent Living; Prevalence; Drug Interactions; Nursing Homes; Skilled Nursing Facilities
PubMed: 36692678
DOI: 10.1007/s40266-022-01001-5 -
BMJ Open Mar 2020The aim of this review is to summarise the latest evidence on efficacy and safety of treatments for new-onset atrial fibrillation (NOAF) in critical illness.
OBJECTIVES
The aim of this review is to summarise the latest evidence on efficacy and safety of treatments for new-onset atrial fibrillation (NOAF) in critical illness.
PARTICIPANTS
Critically ill adult patients who developed NOAF during admission.
PRIMARY AND SECONDARY OUTCOMES
Primary outcomes were efficacy in achieving rate or rhythm control, as defined in each study. Secondary outcomes included mortality, stroke, bleeding and adverse events.
METHODS
We searched MEDLINE, EMBASE and Web of Knowledge on 11 March 2019 to identify randomised controlled trials (RCTs) and observational studies reporting treatment efficacy for NOAF in critically ill patients. Data were extracted, and quality assessment was performed using the Cochrane Risk of Bias Tool, and an adapted Newcastle-Ottawa Scale.
RESULTS
Of 1406 studies identified, 16 remained after full-text screening including two RCTs. Study quality was generally low due to a lack of randomisation, absence of blinding and small cohorts. Amiodarone was the most commonly studied agent (10 studies), followed by beta-blockers (8), calcium channel blockers (6) and magnesium (3). Rates of successful rhythm control using amiodarone varied from 30.0% to 95.2%, beta-blockers from 31.8% to 92.3%, calcium channel blockers from 30.0% to 87.1% and magnesium from 55.2% to 77.8%. Adverse effects of treatment were rarely reported (five studies).
CONCLUSION
The reported efficacy of beta-blockers, calcium channel blockers, magnesium and amiodarone for achieving rhythm control was highly varied. As there is currently significant variation in how NOAF is managed in critically ill patients, we recommend future research focuses on comparing the efficacy and safety of amiodarone, beta-blockers and magnesium. Further research is needed to inform the decision surrounding anticoagulant use in this patient group.
Topics: Adrenergic beta-Antagonists; Adult; Amiodarone; Atrial Fibrillation; Calcium Channel Blockers; Critical Illness; Humans; Magnesium; Stroke
PubMed: 32209631
DOI: 10.1136/bmjopen-2019-034774